33192 - Hepatitis C Virus (HCV) ChLIA | Clinical

Clinical Utility

The Abbott PRISM HCV assay is a chemiluminescent immunoassay for the qualitative detection of antibodies to HCV. This assay is intended to screen donors of blood and blood components and premortem organ donors.

Procedure

The ABBOTT PRISM HCV assay is a two-step sandwich ChLIA. The reactions occur within the ABBOTT PRISM System in the following sequence.

Microparticles coated with HCV recombinant antigens are incubated with Specimen Diluent and sample (either plasma, serum, calibrator or control) in the incubation well of the reaction tray. During incubation, HCV antibodies present int he sample bind to the antigen(s) on the Microparticles.
After this first incubation is complete, the reaction mixture is transferred to the glass fiber matrix (matrix) of the reaction tray using the Transfer Wash. The Microparticles are captured by the matrix while the remaining mixture flows through to the absorbent blotter.
The Anti-Biotin (Mouse Monoclonal): Acridinium Conjugate/Biotinylated F (ab')₂Fragment (Goat) Anti-Human IgG is added to the Microparticles on the matrix and incubated. After this second incubation, the unbound Conjugate is washed into the blotter with the Conjugate Wash.
The chemiluminescent signal is generated by addition of an alkaline hydrogen peroxide solution. The resultant photons are counted.

The amount of light emitted is proportional to the amount of anti-HCV in the sample. The presence or absence of anti-HCV in the sample is determined by comparing the number of photons collected from the sample to a cutoff value determined from a calibration performed in the same batch. If the number of photons collected from a test sample is less than the cutoff value, the sample is considered nonreactive for anti-HCV by the criteria of the ABBOTT PRISM HCV assay. These specimens need not be further tested. If the number of photons collected from a test sample is greater than or equal to the cutoff value, the sample is considered reactive for anti-HCV by the criteria of the ABBOTT PRSIM HCV assay. Specimens that tare initially reactive must be handled according to the table in the SPECIMEN COLLECTION AND PREPARATION FOR ANALYSIS section of this package insert and retested in duplicate. Follow appropriate FDA recommendations and regulations for specimens found to be repeatedly reactive. See package insert for more information. Testing is performed by Indiana Blood Center, 3450 N. Meridian St. Indianapolis, IN 46208, CLIA #: 15D0664398.

Turnaround Time

1-2 days from receipt of specimen. Set up and reported Monday - Sunday.

Specimen Information

Specimen Type	Test Code	CPT Code	NY Approved	Volume	Assay Range	Special Instructions
Serum (1)	33192		Yes	3 mL	Qualitative	Collect whole blood in an gold, red, or red/gray tiger top tube. Do not freeze whole blood. Sample sent in original vacutainer tube can be shipped at ambient temperature and must be received within 7 days. Can be shipped refrigerated temperature and must be received within 14 days of collection. If not shipping in original container, centrifuge and transfer 3 mL serum to screw top tube. Serum shipped at ambient temperature must be received within 7 days of collection. Serum shipped at refrigerated temperature must be received within 14 days of collection or frozen. Stable at a combination of 15-30ºC and 2-8ºC for no more than 14 days and at ≤ -20°C for up to 3 months following separation from the clot. No more than 6 freeze/thaw cycles.
plasma	33192		Yes	3 mL	Qualitative	Collect whole blood in an EDTA, Sodium Citrate or Plasma Separator tube. Do not freeze whole blood. Sample sent in original vacutainer tube can be shipped at ambient temperature and must be received within 7 days. Can be shipped refrigerated temperature and must be received within 14 days of collection. If not shipping in original container, centrifuge and transfer 3 mL plasma to screw top tube. Plasma shipped at ambient temperature must be received within 7 days of collection. Serum shipped at refrigerated temperature must be received within 14 days of collection or frozen. Stable at a combination of 15-30ºC and 2-8ºC for no more than 14 days and at ≤ -20°C for up to 3 months following separation from the clot. No more than 6 freeze/thaw cycles.

Shipping

All specimens must be labeled with patient's name and collection date. A Eurofins Viracor/DPT Pre-Transplant test requisition form must accompany each specimen. Multiple tests can be run on one specimen. Ship specimens FedEx Priority Overnight® to: Eurofins DPT, 6933 S. Revere Parkway, Centennial, CO 80112.

Causes for Rejection

Whole blood frozen, specimens beyond their acceptable length of time from collection as listed in the specimen handling, or specimen types other than those listed.

Disclaimer

Specimens are approved for testing in New York only when indicated in the Specimen Information field above. The CPT codes provided are based on Eurofins DPT's interpretation of the American Medical Association's Current Procedural Terminology (CPT) codes and are provided for informational purposes only. CPT coding is the sole responsibility of the billing party. Questions regarding coding should be addressed to your local Medicare carrier. Eurofins DPT assumes no responsibility for billing errors due to reliance on the CPT codes illustrated in this material.