Test DIRECTORY
Explore our comprehensive menu of laboratory tests designed to support accurate, reliable results across every specialty.
APG LAB's test directory provides a comprehensive list of specialty and general laboratory testing services.
There are currently 35 names in this directory beginning with the letter P.
Pancreatitis: PRSS1 (Known Mutation)
Test Includes
This test looks for presence or absence of familial mutations. The number of amplicons tested depends on the number and location of the familial mutations.
Special Instructions
This option is available when the mutation is known and can be documented by the ordering physician. If the mutation cannot be documented, please order test 252773.
Expected Turnaround Time
21 - 28 days
Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.
Related Documents
For more information, please view the literature below.
Chronic Pancreatitis Genetic Testing
Consent for Genetic Testing (Consentimiento para análisis genético)
Test Details
Methodology
DNA sequencing
Papain
Expected Turnaround Time
3 - 4 days
Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.
Related Information
Related Documents
Specimen Requirements
Specimen
Serum
Volume
0.2 mL
Container
10 mL red-top tube or 10 mL gel-barrier tube
Storage Instructions
Room temperature
Stability Requirements
| Temperature | Period |
|---|---|
| Room temperature | 14 days |
| Refrigerated | 14 days |
| Frozen | 3 months |
| Freeze/thaw cycles | Stable x3 |
Test Details
Methodology
Thermo Fisher ImmunoCAP®
Parasite Identification, Worm
Synonyms
- Gross Worm Identification
Expected Turnaround Time
2 - 7 days
Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.
Related Information
Related Documents
For more information, please view the literature below.
Microbiology Specimen Collection and Transport Guide
Specimen Requirements
Specimen
Worm or segment of worm from urine, stool, sputum, or other clinical specimen
Container
Worms, or portions of them, must be submitted in formalin; the ova and parasite vial (Para-Pak® pink) may be used.
Storage Instructions
Maintain specimen at room temperature.
Causes for Rejection
Improper labeling; dry specimen
Test Details
Use
Diagnose parasitic infestation; identify worms recovered from patient; eliminate possibility of parasite presence
Methodology
Macroscopic and microscopic evaluation
Parathyroid Hormone (PTH) Plus Calcium
Synonyms
- PTH Intact
Special Instructions
This test may exhibit interference when sample is collected from a person who is consuming a supplement with a high dose of biotin (also termed as vitamin B7 or B8, vitamin H, or coenzyme R). It is recommended to ask all patients who may be indicated for this test about biotin supplementation. Patients should be cautioned to stop biotin consumption at least 72 hours prior to the collection of a sample.
Expected Turnaround Time
Within 1 day
Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.
Related Documents
Specimen Requirements
Specimen
Plasma and serum
Volume
1.5 mL plasma and 1 mL serum
Minimum Volume
0.7 mL plasma and 0.5 mL serum
Container
Lavender-top (EDTA) tube and red-top tube or gel-barrier tube
Collection
Transfer separated plasma to a plastic transport tube clearly labeled as EDTA plasma and maintain refrigerated temperature. If red-top tube is used, transfer serum to a plastic transport tube clearly labeled as serum.
Storage Instructions
Refrigerate
Stability Requirements
| Temperature | Period |
|---|---|
| Room temperature | 3 days |
| Refrigerated | 3 days |
| Frozen | 14 days |
| Freeze/thaw cycles | Stable x3 |
Causes for Rejection
Whole blood; plasma other than EDTA; hemolysis; room temperature serum sent for PTH intact
Test Details
Use
Differential diagnosis of hypercalcemia. PTH is an 84-amino acid peptide hormone that is responsible for the regulation of serum calcium levels within a narrow range.
PTH is secreted in response to decrease in serum calcium levels by increasing the renal reabsorption of calcium and lowering reabsorption of phosphorus. The measurement of PTH is a useful tool in the differential diagnosis and management of hypercalcemia. PTH assays can be of help in the diagnosis of tumors and hyperplasia of the parathyroid gland, as well as in localizing hyperfunctioning parathyroid tissue by assay of samples obtained via venous catheterization. The native or intact (1-84) PTH has a short half-life, measured in minutes, whereas the carboxy and midmolecule fragments, which are biologically inactive, have half-lives 10- to 20-fold higher. The high concentrations of biologically inactive fragments have interfered with use of C-terminal or midmolecule assays for evaluation of parathyroid function in patients with impaired renal function. Intact PTH assays provide a more accurate assessment of parathyroid patients including those with various renal diseases.
Methodology
Plasma: electrochemiluminescence immunoassay (ECLIA); serum: colorimetric
Parathyroid Hormone (PTH), Intact
Synonyms
- PTH Whole Molecule
Special Instructions
This test may exhibit interference when sample is collected from a person who is consuming a supplement with a high dose of biotin (also termed as vitamin B7 or B8, vitamin H, or coenzyme R). It is recommended to ask all patients who may be indicated for this test about biotin supplementation. Patients should be cautioned to stop biotin consumption at least 72 hours prior to the collection of a sample.
Expected Turnaround Time
Within 1 day
Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.
Related Documents
Specimen Requirements
Specimen
Plasma (preferred)
Volume
1.5 mL
Minimum Volume
0.7 mL (Note: This volume does not allow for repeat testing.)
Container
Lavender-top (EDTA) tube (preferable)
Collection
Transfer separated plasma into a plastic transport tube clearly labeled as "EDTA Plasma" and maintain at refrigerated temperature.
Storage Instructions
Refrigerate (preferable)
Stability Requirements
| Temperature | Period |
|---|---|
| Room temperature | 3 days |
| Refrigerated | 3 days |
| Frozen | 14 days |
| Freeze/thaw cycles | Stable x3 |
Causes for Rejection
Whole blood; plasma other than EDTA; hemolysis; room temperature or refrigerated serum
Test Details
Use
Diagnosis of parathyroid disease and other diseases of calcium homeostasis; monitoring patients undergoing renal dialysis
Methodology
Electrochemiluminescence immunoassay (ECLIA)
Reference Interval
See table.1
| Intact PTH (pg/mL) | Calcium (mg/dL) | Interpretation |
|---|---|---|
| 15−65 | 8.6−10.2 | Normal |
| >65 | >10.2 | Primary hyperparathyroidism |
| >65 | <10.2 | Secondary hyperparathyroidism |
| <65 | >10.2 | Nonparathyroid hypercalcemia |
| <15 | <8.6 | Hypoparathyroidism |
| 15−65 | <8.6 | Nonparathyroid hypocalcemia |
Additional Information
PTH is an 84-amino-acid peptide hormone which is responsible for the regulation of serum calcium levels within a narrow range. PTH is secreted in response to decrease in serum calcium levels by increasing the renal reabsorption of calcium and lowering reabsorption of phosphorus. The measurement of PTH is a very useful tool in the differential diagnosis and management of hypercalcemia. PTH assays can be of help in the diagnosis of tumors and hyperplasia of the parathyroid gland, as well as in localizing hyperfunctioning parathyroid tissue by assay of samples obtained via venous catheterization. The native or intact (1-84) PTH has a short half-life, measured in minutes, whereas the carboxy and midmolecule fragments, which are biologically inactive, have half-lives 10- to 20-fold higher. The high concentrations of biologically inactive fragments have interfered with use of C-terminal or midmolecule assays for evaluation of parathyroid function in patients with impaired renal function. Intact PTH assays provide a more accurate assessment of parathyroid patients including those with various renal diseases.
Parentage/Relationship Testing
Synonyms
- DNA Analysis for Parentage Evaluation
- Exclusion of Parentage
- Genetic testing for parentage Evaluation
- Grandparent Studies
- Immigration Testing
- Parentage Studies
- Paternity Testing
- Relationship testing
- Sibling determination
- STR Analysis
Special Instructions
Appointments and paternity kits are required. Specimens must be collected with chain-of-custody paperwork. Clinical account numbers cannot be used. To receive a complete paternity kit, blood or buccal swab, set up account numbers, or for an appointment, telephone 800-742-3944.
Expected Turnaround Time
2 - 14 days
Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.
Related Documents
Specimen Requirements
Storage Instructions
Maintain specimen at room temperature and keep dry.
Causes for Rejection
Inadequate labeling; improperly filled-out client authorization/chain-of-custody form; insufficient amount of DNA on buccal swabs
Test Details
Use
Determine the chance of paternity or nonpaternity in cases of disputed paternity, establish blood relationship of potential immigrant, sibling determination, grandparent/child testing, other relationships
Limitations
Probability of parentage is provided for nonexcluded individuals, which is a probability, not a “yes” answer. Some tests may be inconclusive. Mutations, related alleged fathers, and other genetic limitations may affect the test.
Methodology
DNA analysis by polymerase chain reaction (PCR)
Parvovirus B19, DNA PCR
Synonyms
- B19
- Parvo
Expected Turnaround Time
4 - 5 days
Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.
Specimen Requirements
Specimen
Whole blood
Volume
1 mL
Minimum Volume
0.5 mL
Container
Lavender-top (EDTA) tube
Storage Instructions
Refrigerate
Stability Requirements
| Temperature | Period |
|---|---|
| Room temperature | 7 days |
| Refrigerated | 7 days |
| Frozen | Unstable |
Causes for Rejection
Quantity not sufficient for analysis; gross specimen contamination; specimen too old; leaking or broken tube; frozen specimen
Test Details
Use
This test is intended to be used as an aid in the diagnosis of infections caused by parvovirus B19.
Methodology
Real-time polymerase chain reaction (PCR)
PD-L1 IHC (Nivolumab) Squamous Cell Carcinoma of the Head and Neck
Synonyms
- OPDIVO®
- Programmed Death Ligand 1
Special Instructions
Please provide a copy of the pathology report.
Note: This test number is used for tracking oncology IHC specimens to the laboratory. Bill codes will be added when testing is complete, based on the processes performed in the laboratory.
Expected Turnaround Time
5 - 9 days
Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.
Related Documents
Specimen Requirements
Specimen
Tissue
Volume
One formalin-fixed paraffin embedded (FFPE) tissue block or five unstained positively charged slides sectioned from FFPE tissue block at 4 to 5 microns.
Minimum Volume
Three unstained tissue slides
Container
Tissue block or slide
Collection
Tissue should be fixed in 10% neutral buffered formalin for no more than 72 hours. Embed in paraffin.
Storage Instructions
Room temperature
Causes for Rejection
Insufficient tissue; tumor other than squamous cell carcinoma of the head and neck
Test Details
Methodology
Immunohistochemistry (IHC)
Penicillium chrysogenum
Synonyms
- Penicillium Notatum
Expected Turnaround Time
2 - 4 days
Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.
Related Information
Related Documents
Specimen Requirements
Specimen
Serum
Volume
0.2 mL
Container
Red-top tube or gel-barrier tube
Storage Instructions
Room temperature
Stability Requirements
| Temperature | Period |
|---|---|
| Room temperature | 14 days |
| Refrigerated | 14 days |
| Frozen | 3 months |
| Freeze/thaw cycles | Stable x3 |
Test Details
Methodology
Thermo Fisher ImmunoCAP®
Phencyclidine (PCP) Screen with Reflex Confirmation, Meconium
Test Includes
Phencyclidine (PCP)
Expected Turnaround Time
3 - 6 days
Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.
Specimen Requirements
Specimen
Meconium
Volume
5 grams
Minimum Volume
1 gram
Container
Meconium Collection Kit (PeopleSoft No. 96663) or clean, leakproof polypropylene container
Collection
Specimens from different voidings may be pooled if necessary. For step-by-step instructions for collecting and preparing meconium specimens, see Meconium Testing Collection Instructions.
Storage Instructions
Submission/transport (<3 days):Room temperature. For storage beyond three days, specimen should be refrigerated or frozen.
Test Details
Use
Detect fetal exposure to phencyclidine
Methodology
Initial presumptive testing by immunoassay at a testing threshold of 25 ng/gm. Presumptive positives confirmed by definitive liquid chromatography/tandem mass spectrometry (LC/MS-MS).
Phoma betae
Expected Turnaround Time
2 - 4 days
Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.
Related Information
Related Documents
Specimen Requirements
Specimen
Serum
Volume
0.2 mL
Container
Red-top tube or gel-barrier tube
Storage Instructions
Room temperature
Stability Requirements
| Temperature | Period |
|---|---|
| Room temperature | 14 days |
| Refrigerated | 14 days |
| Frozen | 3 months |
| Freeze/thaw cycles | Stable x3 |
Test Details
Methodology
Thermo Fisher ImmunoCAP®
Phosphorus
Synonyms
- Inorganic Phosphate, Blood
Expected Turnaround Time
Within 1 day
Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.
Related Documents
Specimen Requirements
Specimen
Serum (preferred) or plasma
Volume
1 mL
Minimum Volume
0.5 mL
Container
Red-top tube, gel-barrier tube, green-top (heparin) tube, or lavender-top (EDTA) tube
Collection
Separate serum or plasma from cells within 45 minutes of collection.
Storage Instructions
Maintain specimen at room temperature.
Stability Requirements
| Temperature | Period |
|---|---|
| Room temperature | 7 days |
| Refrigerated | 14 days |
| Frozen | 14 days |
| Freeze/thaw cycles | Stable x3 |
Patient Preparation
Patient should be fasting.
Causes for Rejection
Hemolysis; gross lipemia; improper labeling
Test Details
Use
Causes of high phosphorus: Youth; exercise; dehydration and hypovolemia; high phosphorus content enema; acromegaly; hypoparathyroidism; pseudohypoparathyroidism; bone metastases; hypervitaminosis D; sarcoidosis; milk-alkali syndrome; liver disease, such as portal cirrhosis; catastrophic events such as cardiac resuscitation, pulmonary embolism, renal failure; diabetes mellitus with ketosis; serum artifact−sample not refrigerated; overheated, hemolyzed sample, or serum allowed to remain too long on the clot.
Although phosphate accumulation occurs as renal disease progresses, hyperphosphatemia is not a feature of early renal failure;1 it does not usually develop before renal function has diminished to about 25% of normal.2 Osteitis fibrosa in uremic subjects, from excessive bone turnover, relates to hyperphosphatasia. The role of hyperphosphatemia in promotion of such secondary hyperparathyroidism is well established.3 A relationship to osteomalacia in hemodialysis patients exists.3
Causes of low phosphorus: (Hypophosphatemia may occur with or without phosphate depletion. Serum levels vary as much as 2.0 mg/dL during the day.)
Very severely malnourished subjects may have low phosphate levels, but even in starvation, phosphorus levels usually are normal. Antacids, diuretics, and long term steroids are among the common agents bearing a relationship to severe hypophosphatemia.4 Recent carbohydrate ingestion decreases phosphorus, as does intravenous glucose administration; cases of hypophosphatemia relate to I.V. carbohydrate,4 dialysis, hyperalimentation, prolonged intravenous administration of phosphate-free fluids, metabolic states involving glucose, potassium, and pH. Depletion of phosphate occurs in diabetic ketoacidosis. Like potassium, phosphorus returns to the cell with therapy of diabetic ketoacidosis and serum levels may diminish significantly during treatment. Osmotic diuresis induced by glycosuria in poorly controlled diabetes may lead to urinary phosphate losses with negative phosphorus balance. PO4 levels may prove useful in initiation of insulin therapy, in diabetic ketoacidosis and other situations of insulin lack; with hyperglucagonemia, corticosteroid and epinephrine use, and in respiratory alkalosis. Association of hypophosphatemia with impaired glucose metabolism is thought to reflect decreased tissue sensitivity to insulin.5 Alcoholism and other hepatic disorders are found very frequently among patients with low PO4. Alcoholic ketosis and alcohol withdrawal are among causes of hypophosphatemia. There is a slight decrease in serum phosphorus in the last trimester of pregnancy.
Primary hyperparathyroidism and other causes of calcium elevation, including ectopic hyperparathyroidism (pseudohyperparathyroidism).
Patients with sepsis, including Legionnaires' disease and other respiratory infections. Twenty-two percent of instances of respiratory infections had serum phosphorous ≤2.4.6 Halevy and Bulvik report gram-negative septicemia as a common cause of severe hypophosphatemia among 55,000 chemistry profiles of hospitalized patients they studied.4 (Hypophosphatemia impairs bactericidal activity).
Vitamin D deficiency; osteomalacia, inherited and sporadic forms of hypophosphatemic rickets. In work-up for osteomalacia, look for decreased calcium and phosphorus and increased alkaline phosphatase. Biopsy, however, can be abnormal even when these biochemical parameters are within normal limits.
Renal tubular disorders (Fanconi syndrome, renal tubular acidosis); use of antacids that bind phosphorus (look for hypercalciuria, low urinary phosphorus, high alkaline phosphatase);7 dialysis, vomiting; saline or lactate I.V.; steatorrhea, malabsorption, severe diarrhea, nasogastric suction; hypokalemia; negative nitrogen balance; decreased dietary PO4 intake; recovery from severe burn injury; salicylate poisoning; acute gout; tumor-related: described as including hemangiopericytomas (uncommon pathologic entities) and neurofibromatosis; transfusion of blood; arteriography.
The signs and symptoms of phosphate depletion may include neuromuscular, neuropsychiatric, gastrointestinal, skeletal, and cardiopulmonary systems. Manifestations usually are accompanied by serum levels <1.0 mg/dL.
Severe hypophosphatemia is most common in elderly patients and is often found in postoperative subjects.4
Complications of hypophosphatemia: Effect on RBC 2,3-diphosphoglycerate and oxygen dissociation.8 Depression of myocardial function (contractibility), decreased cardiac output; respiratory failure and respiratory muscle weakness; increased incidence of sepsis, impairment of bactericidal activities.9 CNS consequences: polyradiculopathy, paresthesias, tremor, ataxia, weakness, slurred speech, stupor, coma, seizure; joint stiffness; myopathy; renal stones, hypercalciuria secondary to renal phosphate leak; insulin resistance, glucose intolerance. Rhabdomyolysis may complicate marked hypophosphatemia. A mortality rate of 20% is described in patients whose phosphorus concentration was 1.1−1.5 mg/dL.4
Methodology
Colorimetric
Phthalic Anhydride
Expected Turnaround Time
3 - 4 days
Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.
Related Information
Related Documents
Specimen Requirements
Specimen
Serum
Volume
0.2 mL
Container
Red-top tube or gel-barrier tube
Storage Instructions
Room temperature
PIK3CA Mutation Analysis, Breast Cancer
Synonyms
- PIK3CA
Special Instructions
Please provide a copy of the pathology report. Testing will be delayed if the pathology report is not received. Please direct any questions regarding this test to customer service at 800-345-4363.
Expected Turnaround Time
5 - 7 days
Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.
Specimen Requirements
Specimen
Formalin-fixed, paraffin-embedded tissue (FFPE) block or slides from tissue resection or core needle biopsy (CNB)
Volume
Formalin-fixed, paraffin-embedded tissue (FFPE) block or 6 unstained slides at 4-5m and one matching H&E-stained slide or 7 unstained slides
Minimum Volume
3 unstained slides at 4-5m and one matching H&E-stained slide or 4 unstained slides. Resection or Surgical Biopsies require > or =10% tumor content. Core Needle Biopsies require a minimum of > or = 20 mm2 tumor area total available for extraction. Minimum volume allows only one attempt at DNA extraction.
Container
FFPE block or slides
Collection
Ship specimen at room temperature. Please direct any questions regarding this test to customer service at 800-345-4363.
Storage Instructions
Maintain blocks/slides at room temperature.
Causes for Rejection
Specimen does not meet all of the above criteria for sample type, container, minimum volume, collection and storage; specimens containing suspicious foreign material; no tumor tissue in FFPE block or slides; broken or stained slides; fixative other than formalin
Test Details
Use
The therascreen PIK3CA RGQ RT-PCR Kit is a real-time, qualitative PCR assay for the detection of 11 mutations in the phosphatidyl 3-kinases catalytic subunit alpha (PIK3CA) gene (Exon 7: C420R; Exon 9: E542K; E545A, E545D [1635G>T only], E545G, E545K, Q546E, Q546R; and Exon 20: H1047L, H1047R, H1047Y) using genomic DNA (gDNA) extracted from formalin-fixed paraffin-embedded (FFPE) breast tumor tissue. The test is intended to aid clinicians in identifying breast cancer patients who may be eligible for treatment with PIQRAY(R) (alpelisib) based on a PIK3CA Mutation Detected result. Patients whose FFPE tissue produce a positive therascreen PIK3CA RGQ PCR Kit test result for the presence of one or more PIK3CA mutations are eligible for treatment with PIQRAY® (alpelisib).
Table 1. List of mutations detected and COSMIC identities
| Exon | Mutation | COSMIC* ID | Base Change |
|---|---|---|---|
| 7 | C420R | 757 | 1258 T>C |
| 9 | E542K | 760 | 1624 G>A |
| 9 | E545A | 12458 | 1634 A>C |
| 9 | E545D | 765 | 1635G>T |
| 9 | E545G | 764 | 1634A>G |
| 9 | E545K | 763 | 1633 G>A |
| 9 | Q546E | 6147 | 1636 A>G |
| 9 | Q546R | 12459 | 1637 A>G |
| 20 | H1047L | 776 | 3140 A>T |
| 20 | H1047R | 775 | 3140 A>G |
| 20 | H1047Y | 774 | 3139 C>T |
| * COSMIC: Catalogue of somatic mutations in cancer: https://cancer.sanger.ac.uk/cosmic | |||
Limitations
Results from the product must be interpreted within the context of all relevant clinical and laboratory findings and are not to be used alone for diagnosis.
Samples with results reported as "No Mutation Detected" may harbor PIK3CA mutations not detected by the therascreen PIK3CA RGQ PCR Kit.
Detection of mutations is dependent on sample integrity and the amount of amplifiable DNA present. The test procedure should be repeated if analysis of the DNA in the sample indicates that the quantity and/or quality is either not sufficient or the concentration is too high for mutation analysis.
The therascreen PIK3CA RGQ PCR Kit is used in a PCR procedure. As with all PCR procedures, samples may become contaminated by external sources of DNA in the test environment and the DNA in the positive control. Use caution to avoid contamination of samples and kit reagents.
If the sample contains less than the percentage of mutant alleles that is able to be detected by the therascreen PIK3CA RGQ PCR Kit, it will lead to a result of "No Nutation Detected."
It is not known whether the therascreen PIK3CA RGQ PCR Kit shows cross-reactivity (results of "Mutation Detected") to additional PIK3CA mutations different than those included in the kit.
The therascreen PIK3CA RGQ PCR Kit is a qualitative test. The test will not provide quantitative measurements of the Mutant Allele Frequency (MAF) present in a sample.
The impact of the performance of the therascreen PIK3CA RGQ PCR Kit is unknown if microbial contamination is introduced during assay procedures; operators must exercise due caution to avoid introduction of microbial contaminants during testing procedures and should not use kit components if evidence of microbial growth is observed.
The therascreen PIK3CA RGQ PCR Kit is only for use with DNA extracted from formalin-fixed, paraffin-embedded breast cancer tissue.
The therascreen PIK3CA RGQ PCR Kit is only for use with the QIAamp DSP DNA FFPE Tissue Kit (for tissue specimens).
Methodology
The therascreen PIK3CA RGQ PCR Kit is a real-time qualitative PCR in vitro diagnostic test, performed on the Rotor-Gene Q MDx (US) instrument. It uses allele refractory mutation system (ARMS) primers, hydrolysis probes and PCR clamp technologies to detect 11 mutations in exons 7, 9 and 20 of the PIK3CA oncogene against a background of wild-type gDNA.
Plasminogen Gene Sequencing
Special Instructions
The PLG gene is sequenced using Next Generation Sequencing (NGS).
Specimen Requirements
Specimen
Whole blood; acceptable alternate: cheek swab (buccal swab)
Volume
3 mL
Minimum Volume
1 mL
Container
Lavender-top (EDTA) tube
Collection
Invert tube 4 times to ensure adequate mixing.
Storage Instructions
Room temperature
Stability Requirements
| Temperature | Period |
|---|---|
| Room temperature | 1 month |
Causes for Rejection
Sample contamination
Test Details
Use
PLG is the human gene coding for the plasminogen protein. Plasminogen deficiency is the major disorder associated with mutations in PLG.
Limitations
This genetic panel is designed to detect single nucleotide variants, multiple nucleotide variants, smallindels (<50bps), and large copy number variations (deletions or duplications spanning multiple exons). The panel may miss some structural variants such as inversions, translocations, medium sized deletions/duplications, and medium/large insertions; these types of structural variants are considered to be rare, and are challenging to detect for any clinical method without prior knowledge of the nature and location of the specific structural variant.Copy number assays determine the presence of zero, one, two (normal), or three plus copies (ie, it cannot distinguish four from five copies, though either would be abnormal) of the gene or gene region. This test does not detect acquired or non-hereditary disorder.
Methodology
Next Generation Sequencing (NGS)
Potassium
Expected Turnaround Time
Within 1 day
Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.
Related Documents
Specimen Requirements
Specimen
Serum (preferred) or plasma
Volume
1 mL
Minimum Volume
0.5 mL
Container
Red-top tube, gel-barrier tube, or green-top (heparin) tube
Collection
Separate serum or plasma from cells within 45 minutes of collection; avoid hemolysis.
Storage Instructions
Maintain specimen at room temperature or refrigerate.
Stability Requirements
| Temperature | Period |
|---|---|
| Room temperature | 14 days |
| Refrigerated | 14 days |
| Frozen | 14 days |
| Freeze/thaw cycles | Stable x3 |
Causes for Rejection
Hemolysis; improper labeling
Test Details
Use
Evaluate electrolyte balance; followed patients on diuretic therapy and with renal diseases, particularly salt-losing nephropathy; evaluate patients being treated for acidosis; prevent cardiac arrhythmias; evaluate alcoholism with delirium tremens; evaluate and treat ketoacidosis in diabetes mellitus; evaluate acid-base balance, water balance; manage intravenous therapy; evaluate anion gap; evaluate muscular weakness, leukemia, diseases of the gastrointestinal tract including laxative abuse, large villous adenomas, emesis, fistulas and tube drainage; detect, diagnose, and manage mineral corticoid excess (primary aldosteronism, Cushing syndrome, tumor with ectopic ACTH production, some cases of congenital adrenal hyperplasia); licorice ingestion. Potassium is increased in oliguria, anuria, urinary obstruction, renal failure due to shock (decreased removal of potassium), and renal tubular acidosis. Potassium is decreased in three ways:
• Inadequate intake
• Excessive loss due to diarrhea or vomiting or decreased reabsorption due to increased secretion of mineralocorticosteroids
• Movement into the cell as occurs with conditions causing alkalosis
Methodology
Ion-selective electrode (ISE)
Reference Interval
See table.
| Age | Range (mmol/L) |
|---|---|
| 0 to 7 d | 3.7−5.2 |
| 8 to 30 d | 3.7−6.4 |
| 1 to 6 m | 3.8−6.0 |
| 7 m to 1 y | 3.8−5.3 |
| >1 y | 3.5−5.2 |
Additional Information
Hypokalemia (low potassium) has been found in >90% of hypertensive patients with primary aldosteronism (Conn syndrome). This uncommon entity is a curable cause of hypertension. Low potassium occurs with endogenous or exogenous increase in other corticosteroids, including that in Cushing syndrome as well as with dietary or parenteral deprivation of potassium (eg, parenteral therapy without adequate potassium replacement). Hypokalemia occurs with vomiting, diarrhea, fistulas, laxatives, diuretics, burns, excessive perspiration, Bartter syndrome, some cases of alcoholism and folic acid deficiency, in alkalosis and in renal tubular acidosis as well as in other entities.
Low potassium is much more significant with a low pH than with a high pH. When pH increases by 0.1, potassium decreases approximately 0.6 mmol/L. With low pH, as in ketoacidosis, as therapeutic adjustment towards normal is made, plasma/serum K+ levels will decrease. Phosphorus levels tend to follow potassium levels downwards during therapy of diabetic ketoacidosis; both are largely intracellular. With insulin therapy (and increased utilization of carbohydrate), potassium moves into cells and serum/plasma level falls. Hyperalimentation may have a similar effect. Hypokalemia has been reported in slightly over one-half of a series of 32 patients with acute myelogenous leukemia,1 but thrombocytosis can increase serum potassium levels, vide supra.
Thiazide/chlorthalidone therapy may cause hyperuricemia and hypercalcemia as well as hypokalemia.
The watery diarrhea-hypokalemia-achlorhydria (WDHA) syndrome most often is related to vasoactive intestinal polypeptide (VIP).
Hyperkalemia (high potassium) reflects generally inadequate renal excretion, mobilization of potassium from the tissues, or excessive intake or administration. Hyperkalemia occurs with hemolysis, trauma, with administration of potassium salts of some drugs, Addison disease, acidosis, insulin lack, with increased osmolality (eg, glucose, mannitol), and in other entities as well as with renal diseases. Increased potassium can occur with potassium sparing diuretics, nonsteroidal anti-inflammatory drugs, especially in the presence of renal disease. Systemic heparin therapy can suppress aldosterone release and increase potassium, especially in the presence of other factors.
A discussion of the relation between lactic acidosis and ketoacidosis and elevated serum potassium levels is provided in a paper by Fulop.2
Drug effects are summarized.3
Preëclampsia Monitoring Profile
Synonyms
- Preëclampsia Monitoring Profile Without 24-Hour Urine
Test Includes
Alanine aminotransferase (ALT); aspartate aminotransferase (AST); complete blood count with differential and platelets (CBC); lactic acid dehydrogenase (LD); random urine albumin:creatinine ratio; serum creatinine; serum urea nitrogen (BUN); serum uric acid (SUA)
Expected Turnaround Time
Within 1 day
Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.
Related Information
Related Documents
Specimen Requirements
Specimen
Serum, whole blood, and urine (random)
Volume
1 mL serum, lavender tube filled to capacity, and 10 mL of random urine
Minimum Volume
0.5 mL serum, lavender tube filled to capacity, and 2 mL of random urine (Note: This volume does not allow for repeat testing.)
Container
Gel-barrier tube, lavender-top (EDTA) tube, and plastic urine container
Storage Instructions
Serum and whole blood: Maintain specimen at room temperature. Urine: Refrigerate. Whole blood: Stable for one day at room temperature; refrigerated for three days. Unstable frozen. Serum: Stable at room temperature and refrigerated for seven days. Stable for one day frozen; Freeze/thaw x1. Urine: Stable for seven days at room temperature; refrigerated for 14 days. Stable for 14 days frozen; Freeze/thaw x3.
Causes for Rejection
Serum: Hemolysis; lipemia; improper labeling. Whole blood: specimen other than lavender-top (EDTA) tube; hemolysis; clotted specimen diluted or contaminated with IV fluid; tube not filled with minimum volume; transport tubes with whole blood; specimen received with plasma removed; improper labeling. Random urine: bloody specimen; improper labeling.
Test Details
Use
Aid in management and monitoring of patients suspected or diagnosed with preëclampsia.
Limitations
Results of this profile should be used in conjunction with clinical findings and other diagnostic tests.
Methodology
See individual tests.
Pregnancy Test, Urine
Synonyms
- hCG, Urine
- Human Chorionic Gonadotropin (hCG), Qualitative, Urine
Expected Turnaround Time
Within 1 day
Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.
Related Information
Related Documents
Specimen Requirements
Specimen
Urine (first morning)
Volume
1 mL
Minimum Volume
0.5 mL
Container
Plastic urine container
Collection
Deliver specimen to the laboratory immediately following collection.
Storage Instructions
Refrigerate
Causes for Rejection
Gross contamination with blood or bacteria; specimen older than 48 hours from date and time of collection
Test Details
Use
Confirmation of pregnancy; normal or ectopic (latter is best done by the more sensitive type assay such as ICMA); evaluation of threatened abortion, trophoblastic tumors, support for the diagnosis of testicular tumors, ectopic hCG production by nontrophoblastic tumors
Limitations
Five-minute immunoenzymetric assay: sensitivity − 20 mIU/mL (The test will normally become positive by the seventh day after menstruation fails to occur.) Proteinuria or hematuria may affect the performance of the test. Interpret specimens with these conditions cautiously. False-positive and false-negative results may also occur in specimens from individuals taking a variety of drugs. Urines from patients on methadone replacement therapy >100 mg/day have demonstrated a high incidence of false-positive reactions when using this test. If this condition is suspected and a positive test results, the test should be repeated using a different methodology. False-positives may also be reported with ectopic production of hCG and/or hCG-like substances by trophoblastic or nontrophoblastic neoplasms (eg, ovarian cysts, testicular tumors, carcinoma of the lung). Positive results from patients suspected to have elevated concentrations of pituitary gonadotropins such as LH should be interpreted with caution although cross reactivity is minimal. Positive tests are also found with various types of choriocarcinoma and hydatidiform mole. A complete abortion may result in a positive test for a week following the procedure.
Methodology
Enzyme immunoassay (EIA)
Prenatal Profile I Without Hepatitis B Surface Antigen
Synonyms
- Prenatal B Super Profile With Differential Without HBsAg
Test Includes
ABO grouping and Rh typing; antibody screen (includes ID and titer of all irregular antibodies detected); CBC with differential; rubella antibodies, IgG; syphilis serology (if positive, confirmation is performed by TP-PA at an additional charge)
Expected Turnaround Time
1 - 3 days
Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.
Specimen Requirements
Specimen
Serum and whole blood
Volume
One 10 mL red-top tube, two 5 mL lavender-top (EDTA) tubes, two peripheral blood films, and one additional 10 mL gel-barrier tube
Collection
Gently invert lavender-top tubes immediately to mix specimen with anticoagulant. Make two fresh blood films on glass slides. Centrifuge only the gel-barrier tube within 45 minutes of collection.
Storage Instructions
All specimens are stable at room temperature for three days. The lavender-top tube for CBC must be run within 72 hours. Other specimens are stable refrigerated for seven days.
Causes for Rejection
Hemolysis; clotted specimen; specimen diluted with IV fluid; tube not filled with minimum volume; improper labeling
Test Details
Use
Evaluate a woman's health status early in pregnancy; evaluate for anemia, leukemia, reaction to inflammation and infections, peripheral blood cellular characteristics, state of hydration and dehydration, polycythemia, hemolytic disease of the newborn, and ABO incompatibilities
Methodology
See individual tests.
Prenatal Spinal Muscular Atrophy (SMA) Testing
Synonyms
- Arthron-Ryposis Multiplex Congenita (Prental SMA)
- Congenital Axonal Neurotherapy
- Dubowitz Disease (SMA type II)
- Kugelberg-Welander Disease (SMA type III)
- SMA
- SMN1 Copy-Number Analysis
- Werdnig-Hoffman Disease (SMA type I)
Special Instructions
For prenatal/fetal testing only.
Testing referred to Integrated Genetics. To speak to a laboratory genetic coordinator before collecting specimens, LabCorp Clients, call 800-345-4363; Integrated Genetics clients, call 800-848-4436.
In some circumstances, specimens from other family members may be required. All prenatal specimens (including cord blood) must be accompanied by a maternal blood or mouthwash specimen for analysis of the specimen for possible maternal cell contamination. Cultures are required for prenatal SMA testing.
Related Information
Specimen Requirements
Specimen
Cultured amniotic fluid, or cultured chorionic villus (CVS) cells are required for testing.
Direct specimen can be submitted but a culture fee may be included. Submission of maternal blood is required for analysis of maternal cell contamination (MCC). MCC should be ordered on a separate requisition using test code 511402, Maternal Cell Contamination. Cultures are required for prenatal SMA testing.
Volume
Amniotic fluid: One T-25 flask of confluent cells. CVS: One T-25 flask of confluent cells. If cultured at another facility please maintain back-up cultures.
Container
Amniotic fluid: T-25 flasks
CVS: T-25 flasks
Collection
Amniotic fluid: Discard first 2 mL; then 15 mL amniotic fluid in 15 mL orange-top polypropylene tube. If cultured at another facility: 1 T-25 flask of confluent cells.
Storage Instructions
Maintain specimen at room temperature.
Causes for Rejection
Frozen or hemolyzed specimen; quantity not sufficient for analysis
Test Details
Use
Prenatal diagnosis for at-risk pregnancies, when both parents are carriers or when severe joint contractures are found on fetal ultrasound.
If prenatal diagnosis testing indicated an affected fetus (a 0 SMN1 copy number result), testing will reflex to SMN2 copy number analysis. SMN2, an adjacent gene to SMN1, also encodes low levels of SMN protein. Therefore, an increased SMN2 copy number (3+) may reduce disease severity among affected patients.
Limitations
This copy number analysis does not detect carriers of SMA as a result of either two (or very rarely three) copies of the SMN1 gene on one chromosome False-positive results or false-negative results may occur for reasons that include genetic variants, blood transfusions, bone marrow transplantation, erroneous representation of family relationships, or contamination of a fetal sample with maternal cells.
Methodology
After DNA is isolated, exon 7 of the SMN1 gene and internal standard reference genes are amplified by real-time polymerase chain reaction (PCR). A mathematical algorithm calculates SMN1 copy numbers of 0, 1, 2 or 3 with statistical confidence. To rule out the presence of sequence variants that could interfere with analysis and interpretation, sequence analysis of primer and probe binding sites is performed for postnatal samples with one copy of SMN1 and for all fetal samples. Reflex testing to SMN2 copy number analysis is performed for affected fetus with 0 copies of SMN1.
Privet, Common
Synonyms
- Common Privet
Expected Turnaround Time
3 - 4 days
Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.
Related Information
Related Documents
Specimen Requirements
Specimen
Serum
Volume
0.2 mL
Container
Red-top tube or gel-barrier tube
Storage Instructions
Room temperature
Stability Requirements
| Temperature | Period |
|---|---|
| Room temperature | 14 days |
| Refrigerated | 14 days |
| Frozen | 3 months |
| Freeze/thaw cycles | Stable x3 |
Test Details
Methodology
Thermo Fisher ImmunoCAP®
Proinsulin
Expected Turnaround Time
3 - 5 days
Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.
Related Documents
Specimen Requirements
Specimen
Serum, frozen
Volume
0.6 mL
Minimum Volume
0.4 mL (Note: This volume does not allow for repeat testing.)
Container
Red-top tube or gel-barrier tube
Collection
Transfer the serum into a LabCorp PP transpak frozen purple tube with screw cap (LabCorp N° 49482). Freeze immediately and maintain frozen until tested. To avoid delays in turnaround time when requesting multiple tests on frozen samples, please submit separate frozen specimens for each test requested.
Storage Instructions
Freeze.
Stability Requirements
| Temperature | Period |
|---|---|
| Room temperature | Unstable |
| Refrigerated | Unstable |
| Frozen | 12 days |
| Freeze/thaw cycles | Stable x3 |
Patient Preparation
Baseline proinsulin levels should be collected after a 12-hour fast.
Causes for Rejection
Nonfrozen specimen; nonserum specimen; gross hemolysis; gross lipemia
Test Details
Methodology
Enzyme immunoassay (EIA)
Reference Interval
0.0−10.0 pmol/L
Additional Information
Proinsulin is synthesized in the pancreatic beta cells as a 9390 mw polypeptide of 86 amino acids.1-3 Proinsulin is subsequently cleaved enzymatically, releasing insulin into the circulation along with a residual 3000 mw fragment called C-peptide, so-named because it connects the A and B chains of insulin within the proinsulin molecule.
Proinsulin, which has relatively low biological activity (approximately 10% of insulin potency), is the major storage form of insulin. Normally, only small amounts (∼3% of the amount of insulin, on a molar basis) of proinsulin enter the circulation. Because the hepatic clearance of proinsulin is only 25% of insulin clearance, the half-life of proinsulin is two- to threefold longer and concentrations in the fasting state are approximately 10% to 15% of insulin concentrations.
High proinsulin concentrations have been associated with benign or malignant β-cell tumors of the pancreas4 and endocrine pancreatic tumors associated with MEN-1.5 Elevated proinsulin levels have been observed in individuals with impaired glucose tolerance even in the absence of abnormal glucose or C-peptide levels.6 Elevated proinsulin levels have been found to be a positive risk factor for the development on NIDDM.7,8 Most patients with β-cell tumors have increased insulin, C-peptide, and proinsulin concentrations, but occasionally only proinsulin is elevated. Despite its low biological activity, proinsulin may be increased sufficiently to produce hypoglycemia.9 In addition, a rare form of familial hyperproinsulinemia, due to impaired conversion to insulin, has been described. Increased proinsulin concentrations may also be detected in patients with chronic renal failure, cirrhosis, or hyperthyroidism.
Prolactin, Seven Specimens
Special Instructions
Please refer to the directions for Sequential Sampling.
Expected Turnaround Time
1 - 2 days
Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.
Promethazine, Whole Blood
Synonyms
- Anergan®
- Phenadoz®
- Phenergan®
- Promethegan®
Expected Turnaround Time
7 - 10 days
Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.
Specimen Requirements
Specimen
Whole blood
Volume
3 mL
Minimum Volume
0.6 mL
Container
Lavender-top (EDTA) tube, gray-top (sodium fluoride) tube, or green-top (heparin) tube
Storage Instructions
Submission/transport (<3 days): Room temperature. For storage beyond three days, specimen should be refrigerated or frozen.
Test Details
Use
Therapeutic drug management
Methodology
Liquid chromatography/tandem mass spectrometry (LC/MS-MS)
Propoxyphene/Norpropoxyphene, Screen and Confirmation, Urine
Test Includes
Immunoassay; reflex to confirmation
Special Instructions
This assay is intended for pain management. It is not intended for workplace testing and does not comply with state regulatory workplace testing programs.
Expected Turnaround Time
2 - 5 days
Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.
Specimen Requirements
Specimen
Urine
Volume
20 mL
Container
Plastic urine container
Storage Instructions
Maintain specimen at room temperature. If arrival at lab will extend beyond seven days, refrigerate.
Test Details
Use
Detect and confirm the presence of propoxyphene or norpropoxyphene
Methodology
Initial testing by immunoassay (IA); confirmation of positives by mass spectrometry (MS)
Prostate-specific Antigen (PSA)
Synonyms
- PSA, Serum
Special Instructions
Values obtained with different assays should not be used interchangeably in serial testing. It is recommended that only one assay method be used consistently to monitor each patient's course of therapy. This procedure does not provide serial monitoring; it is intended for one-time use only. If serial monitoring is required, please use the serial monitoring number 480145 to order.
This test may exhibit interference when sample is collected from a person who is consuming a supplement with a high dose of biotin (also termed as vitamin B7 or B8, vitamin H, or coenzyme R). It is recommended to ask all patients who may be indicated for this test about biotin supplementation. Patients should be cautioned to stop biotin consumption at least 72 hours prior to the collection of a sample.
Expected Turnaround Time
Within 1 day
Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.
Related Information
Related Documents
Specimen Requirements
Specimen
Serum
Volume
0.8 mL
Minimum Volume
0.3 mL (Note: This volume does not allow for repeat testing.)
Container
Red-top tube or gel-barrier tube
Collection
If a red-top tube is used, transfer separated serum to a plastic transport tube.
Storage Instructions
Maintain specimen at room temperature.
Stability Requirements
| Temperature | Period |
|---|---|
| Room temperature | 7 days |
| Refrigerated | 7 days |
| Frozen | 14 days |
| Freeze/thaw cycles | Stable x3 |
Causes for Rejection
Plasma or whole blood specimen; hemolysis
Test Details
Use
Prostate-specific antigen (PSA) is a glycoprotein produced by the epithelial cells lining the prostatic ducts and acini. Normally, it is secreted into the prostatic ducts and is present only in prostate tissue, prostatic fluid, and seminal plasma. PSA is produced by normal, hyperplastic, and cancerous prostatic tissue. PSA is used as a tumor marker for the early detection of prostate cancer and in other areas of prostate disease management.1 The Prostate-Specific Antigen Best Practice Statement: 2009 Update published by the American Urologic Association1 describes the use of PSA testing for:
• The evaluation of men at risk for prostate cancer
• Assistance in pretreatment staging
• Risk assessment posttreatment monitoring
• Use as a guide in management of men who recur after primary or secondary therapy
Limitations
The measured PSA value of a patient's sample can vary depending on the testing procedure used.2 PSA values determined on patient's samples by different testing procedures cannot be directly compared with one another and could be the cause of erroneous medical interpretations.2 Results cannot be interpreted as absolute evidence of the presence or absence of malignant disease.1 The PSA value should be used in conjunction with information from clinical evaluation and other diagnostic procedures.1
PSA levels can be elevated in patients with prostatitis.1 Treatment with antibiotics will decrease PSA by approximately 30% in men whose PSA elevation is due to prostatitis alone.1 PSA can also be increased in men with benign prostatic hyperplasia (BPH).1 PSA can be increased due to urethral or prostatic trauma.1 Prostate biopsy can cause substantial elevation of PSA levels.1 Cystoscopy may increase PSA levels immediately after testing.1 Ejaculation and DRE have been reported to increase PSA levels but studies have shown the effects to be variable or insignificant.1 PSA testing can be performed with reasonable accuracy after rectal examination.1
Surgical castration or medical castration (with LHRH-agonist or antiandrogen therapy) can lower PSA levels dramatically.1 Finasteride and dutasteride (5-α reductase inhibitors) can lower PSA levels by approximately 50% regardless of the dose.1 Prostatic intraepithelial neoplasia (PIN) does not increase PSA levels.1
Methodology
Electrochemiluminescence immunoassay (ECLIA)
Prostate-specific Antigen (PSA) (Serial Monitor)
Test Includes
Long-term serial monitoring of results; color graphic summary report
Special Instructions
The account must submit the patient's Social Security number to monitor. Values obtained with different assay methods should not be used interchangeably in serial testing. It is recommended that only one assay method be used consistently to monitor each patient's course of therapy. To order this test without the serial monitor service, order 010322. For a complete test description, see Prostate-Specific Antigen (PSA).
This test may exhibit interference when sample is collected from a person who is consuming a supplement with a high dose of biotin (also termed as vitamin B7 or B8, vitamin H, or coenzyme R). It is recommended to ask all patients who may be indicated for this test about biotin supplementation. Patients should be cautioned to stop biotin consumption at least 72 hours prior to the collection of a sample.
Expected Turnaround Time
1 - 2 days
Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.
Protein and Creatinine, Random Urine
Test Includes
Creatinine; protein, total; protein:creatinine ratio
Expected Turnaround Time
Within 1 day
Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.
Related Documents
Specimen Requirements
Specimen
Urine (random)
Volume
50 mL
Minimum Volume
1 mL
Container
Plastic urine container, no preservative
Collection
Collect random urine in a clean plastic container. Label the urine container with the patient's full name and the date and time of collection.
Storage Instructions
Room temperature
Stability Requirements
| Temperature | Period |
|---|---|
| Room temperature | 7 days |
| Refrigerated | 14 days |
| Frozen | 14 days |
| Freeze/thaw cycles | Stable x3 |
Test Details
Use
Protein:creatinine ratio in a first-morning or random untimed "spot" urine specimen is recommended testing to ascertain chronic kidney disease.1 It is also used to evaluate nephrotic syndromes; work up other renal diseases, including malignant hypertension, glomerulonephritis, Goodpasture syndrome, cryoglobulinemia, toxemia of pregnancy, drug nephrotoxicity, and renal tubular lesions; manage myeloma and macroglobulinemia of Waldenström (Bence Jones proteinuria); evaluate hypoproteinemia; tubular proteinurias, including Wilson's disease and Fanconi syndrome. Albumin/Creatinine Ratio, Random Urine is a more sensitive marker of progression and regression of renal disease than urine total protein, especially when urine total protein is <300 mg/g creatinine.
Methodology
Spectrophotometric
Protein C Antigen/Factor VII Antigen
Test Includes
Protein C antigen; factor VII antigen; protein C:factor VII ratio
Expected Turnaround Time
3 - 6 days
Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.
Related Documents
Specimen Requirements
Specimen
Plasma, frozen
Volume
1 mL
Container
Blue-top (sodium citrate) tube
Collection
Citrated plasma samples should be collected by double centrifugation. Blood should be collected in a blue-top tube containing 3.2% buffered sodium citrate.1 Evacuated collection tubes must be filled to completion to ensure a proper blood to anticoagulant ratio.2,3 The sample should be mixed immediately by gentle inversion at least six times to ensure adequate mixing of the anticoagulant with the blood. A discard tube is not required prior to collection of coagulation samples.4,5 When noncitrate tubes are collected for other tests, collect sterile and nonadditive (red-top) tubes prior to citrate (blue-top) tubes. Any tube containing an alternate anticoagulant should be collected after the blue-top tube. Gel-barrier tubes and serum tubes with clot initiators should also be collected after the citrate tubes. Centrifuge for 10 minutes and carefully remove 2/3 of the plasma using a plastic transfer pipette, being careful not to disturb the cells. Deliver to a plastic transport tube, cap, and recentrifuge for 10 minutes. Use a second plastic pipette to remove the plasma, staying clear of the platelets at the bottom of the tube. Transfer the plasma into a LabCorp PP transpak frozen purple tube with screw cap (LabCorp N° 49482). Freeze immediately and maintain frozen until tested. To avoid delays in turnaround time when requesting multiple tests on frozen samples, please submit separate frozen specimens for each test requested.
Please print and use the Volume Guide for Coagulation Testing to ensure proper draw volume.
Storage Instructions
Freeze.
Causes for Rejection
Hemolysis; clotted specimen; specimen contaminated with heparin (ie, drawn with blood gases); samples containing fibrin clots; specimens received thawed for more than 24 hours
Test Details
Use
This assay is used to obtain a presumptive diagnosis of protein C deficiency while a patient is receiving antivitamin K therapy. Use of this assay is discouraged.
Limitations
The extremely rare presence of antirabbit antibodies in certain subjects leads to aberrant results.
This procedure may be considered by Medicare and other carriers as an investigational and, therefore, may not be payable as a covered benefit for patients.
Methodology
Enzyme-linked immunosorbent assay (ELISA)
Reference Interval
0.5:2.2 ratio
Additional Information
Protein C (PrC) and factor VII (F VII) are vitamin K-dependent factors and may be decreased in patients on stable antivitamin K (warfarin) therapy. By calculating a PrC:VII ratio, a tentative diagnosis of PrC deficiency can be made in those patients receiving stable antivitamin K therapy. A decreased PrC:VII antigen ratio is indicative of a protein C deficiency; however, a final diagnosis of protein C deficiency should not be made until and individual has been removed from warfarin therapy for a minimum of two weeks and then testing repeated. The kindred of protein C deficient individuals should be screened for deficiency both to confirm its hereditary nature and to assess thrombotic risk to family members.
Protein Electrophoresis With Interpretation With Reflex to IFE, Cerebrospinal Fluid
Synonyms
- Interpretation, Protein Electrophoresis With Reflex to IFE, CSF
- Protein Electrophoresis With Interpretation and Reflex to IFE, CSF
Expected Turnaround Time
5 - 7 days
Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.
Related Documents
Specimen Requirements
Specimen
Cerebrospinal fluid (CSF)
Volume
2 mL
Minimum Volume
1.6 mL
Container
Sterile tube
Collection
The third tube of a routinely obtained three-tube set of CSF should be used for protein electrophoretic study.
Storage Instructions
Refrigerate at 2°C to 8°C.
Test Details
Use
Evaluate for possible multiple sclerosis, subacute sclerosing panencephalitis, and other chronic CNS disorders associated with local IgG synthesis
Methodology
Protein electrophoresis on agarose media; agarose gel immunofixation (IFE), if reflexed
Protein Electrophoresis, Random Urine
Synonyms
- Electrophoresis, Protein, Random Urine
- Globulins, Random Urine
Test Includes
Graph with quantitation of total urine protein, urine albumin, urine α1, urine α2, urine β, urine γ-globulin fractions if present; quantitation (in %) of M-spike if present
Special Instructions
For 24-hour urine specimens, order test 003368.
Expected Turnaround Time
2 - 5 days
Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.
Related Documents
Specimen Requirements
Specimen
Urine (random)
Volume
20-mL aliquot
Minimum Volume
6-mL aliquot
Container
12-mL plastic transport tube (LabCorp N° 23597) without preservative
Collection
Collect first morning urine; mix well.
Storage Instructions
Refrigerate at 2°C to 8°C.
Causes for Rejection
Preservative added
Test Details
Use
Evaluate myeloma, macroglobulinemia of Waldenström, lymphoma, amyloidosis; differentiate between normal renal function, glomerular proteinuria, and tubular proteinuria. Increased glomerular permeability leads to higher concentrations of large proteins in the glomerular filtrate. Diminished tubular reabsorptive capacity results in a marked increase in urinary excretion of low molecular weight problems.
Limitations
May not detect pathologic light chains due to insufficient sensitivity. Should be followed with immunoelectrophoretic or immunofixation study performed on concentrated urine. Optimal specimen when looking for a free monoclonal light chain (Bence Jones protein) is a 24-hour collection.
Methodology
Electrophoresis on agarose media
Protein S Antigen
Test Includes
Protein S, total; protein S, free
Special Instructions
If the patient's hematocrit exceeds 55%, the volume of citrate in the collection tube must be adjusted. Refer to Coagulation Collection Procedures for directions.
Expected Turnaround Time
2 - 3 days
Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.
Related Information
Related Documents
For more information, please view the literature below.
Procedures for Hemostasis and Thrombosis: A Clinical Test Compendium
Specimen Requirements
Specimen
Plasma, frozen
Volume
3 mL
Minimum Volume
2 mL
Container
Blue-top (sodium citrate) tube
Collection
Citrated plasma samples should be collected by double centrifugation. Blood should be collected in a blue-top tube containing 3.2% buffered sodium citrate.1 Evacuated collection tubes must be filled to completion to ensure a proper blood to anticoagulant ratio.2,3 The sample should be mixed immediately by gentle inversion at least six times to ensure adequate mixing of the anticoagulant with the blood. A discard tube is not required prior to collection of coagulation samples, except when using a winged blood collection device (ie, "butterfly"), in which case a discard tube should be used.4,5 When noncitrate tubes are collected for other tests, collect sterile and nonadditive (red-top) tubes prior to citrate (blue-top) tubes. Any tube containing an alternate anticoagulant should be collected after the blue-top tube. Gel-barrier tubes and serum tubes with clot initiators should also be collected after the citrate tubes. Centrifuge for 10 minutes and carefully remove 2/3 of the plasma using a plastic transfer pipette, being careful not to disturb the cells. Deliver to a plastic transport tube, cap, and recentrifuge for 10 minutes. Use a second plastic pipette to remove the plasma, staying clear of the platelets at the bottom of the tube. Transfer the plasma into a LabCorp PP transpak frozen purple tube with screw cap (LabCorp No. 49482). Freeze immediately and maintain frozen until tested.
Please print and use the Volume Guide for Coagulation Testing to ensure proper draw volume.
Storage Instructions
Freeze.
Patient Preparation
Avoid warfarin (Coumadin®) therapy for two weeks and heparin therapy for two days prior to the test. Do not draw from an arm with a heparin lock or heparinized catheter.
Causes for Rejection
Gross hemolysis; clotted specimen; frozen specimen thawed in transit; improper labeling
Test Details
Use
Confirmation and characterization of protein S (PS) congenital deficiency
Methodology
Total and free PS antigens are measured by latex immunoassay.
Reference Interval
Total: In newborns, total PS levels are lower than in adults (12% to 60%). Levels gradually reach adult ranges by six months of age.6
Protein, Total
Expected Turnaround Time
Within 1 day
Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.
Related Documents
Specimen Requirements
Specimen
Serum (preferred) or plasma
Volume
1 mL
Minimum Volume
0.5 mL
Container
Gel-barrier tube, transport tube, green-top (heparin) tube, or lavender-top (EDTA) tube
Collection
Separate serum or plasma from cells within four hours of collection.
Storage Instructions
Maintain specimen at room temperature.
Stability Requirements
| Temperature | Period |
|---|---|
| Room temperature | 14 days |
| Refrigerated | 14 days |
| Frozen | 14 days |
| Freeze/thaw cycles | Stable x3 |
Causes for Rejection
Hemolysis; improper labeling
Test Details
Use
Evaluate nutritional status; investigate edema.
In the entities which follow, the diseases listed are sometimes increased or decreased as indicated, but are not always so.
Causes of high total protein: dehydration; some cases of chronic liver disease, including chronic active hepatitis and cirrhosis; neoplasms, especially myeloma; macroglobulinemia of Waldenström; tropical diseases (eg, kala-azar, leprosy, and others); granulomatous diseases, such as sarcoidosis; diseases in which total protein is sometimes high include collagen disease (eg, systemic lupus erythematosus (SLE), and other instances of chronic infection/inflammation).
Causes of low total protein: pregnancy; intravenous fluids; cirrhosis or other liver disease, including chronic alcoholism; prolonged immobilization; heart failure; nephrotic syndromes; glomerulonephritis; neoplasia; protein losing enteropathies; Crohn's disease and chronic ulcerative colitis; starvation, malabsorption or malnutrition; hyperthyroidism; burns; severe skin disease; and other chronic diseases.
Very low total protein (<4 g/dL) and low albumin cause edema (eg, the nephrotic syndromes).
Limitations
Clinical interpretation is greatly enhanced by examination of the fractions composing total protein, when such separation is clinically indicated (ie, serum protein electrophoresis, quantitative immunodiffusion or other methods for IgG, IgA, IgM, immunofixation, immunoelectrophoresis).
Methodology
Colorimetric
Additional Information
Total protein and albumin normally decrease by 5% to 10% upon recumbency, as in hospitalization. Drug effects are summarized.1
Prothrombin Time (PT) (Serial Monitor)
Test Includes
Long-term serial monitoring of results; color graphic summary report
Special Instructions
The account must submit the patient's Social Security number to monitor. Values obtained with different methods should not be used interchangeably in serial testing. It is recommended that only one assay method be used consistently to monitor each patient's course of therapy. To order this test without the serial monitor service, use test 005199. For a complete description, see Prothrombin Time (PT) [005199].
Expected Turnaround Time
Within 1 day
Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.
Common Lab Tests
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This test, also known as a CBC, is the most common blood test performed. It measures the types and numbers of cells in the blood, including red and white blood cells and platelets. This test is used to determine general health status, screen for disorders and evaluate nutritional status. It can help evaluate symptoms such as weakness, fatigue and bruising, and can help diagnose conditions such as anemia, leukemia, malaria and infection.
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Also known as PT and Pro Time, this test measures how long it takes blood to clot. This coagulation test measures the presence and activity of five different blood clotting factors. This test can screen for bleeding abnormalities, and may also be used to monitor medication treatments that prevent the formation of blood clots.
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This test measures glucose, sodium, potassium, calcium, chloride, carbon dioxide, blood urea nitrogen and creatinine which can help determine blood sugar level, electrolyte and fluid balance as well as kidney function. The Basic Metabolic Panel can help your doctor monitor the effects of medications you are taking, such as high blood pressure medicines, can help diagnose certain conditions, or can be part of a routine health screening. You may need to fast for up to 12 hours before this test.
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The lipid panel is a group of tests used to evaluate cardiac risk. It includes cholesterol and triglyceride levels.
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The liver panel is a combination of tests used to assess liver function and establish the possible presence of liver tumors.
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This test is used to diagnose and monitor diabetes.
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Often the first lab test performed, this is a general screening test used to check for early signs of disease. It may also be used to monitor diabetes or kidney disease.
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Cultures are used to test for diagnosis and treatment of infections. Illnesses such as urinary tract infections, pneumonia, strep throat, MRSA and meningitis can be detected and tested for appropriate antibiotic treatment.
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