EFFECTIVE JULY 31, 2008

THE MICROBIOLOGY LABORATORY IS PLEASED TO ANNOUNCE
THE IMPLEMENTATION OF

REAL TIME POLYMERASE CHAIN REACTION (PCR)
FOR HEPATITIS C QUANTITATIVE VIRAL LOAD TESTING

Testing will be performed using Roche Ampliprep-Taqman Real Time PCR Technology, replacing the current Siemens Versant Branched Chain DNA (bDNA) technology.

IMPROVED LOWER DETECTION LIMIT: The lower detection limit of this new assay is 100 Hepatitis C International Units/mL versus 615 IU/mL for the current bDNA assay.

RELIABILITY: This assay detects Hepatitis C genotypes 1A, 1B, 2A, 2B, 3A, 4, 5, and 6.  Quantitation of multiple replicas from serial dilutions of each genotype demonstrated reliability equivalent to the current assay.

CORRELATION: In comparison studies, correlation was excellent; eliminating the need for re-baselining.

REPORTING: Results will be reported in copies/mL, Log10 copies/mL, IU/mL, and Log10 IU/mL.

SPECIMEN COLLECTION:

• Collect blood into TWO dedicated Lavender-top EDTA tubes. 
• Centrifuge tubes within 6 hours of collection. 
• Carefully remove plasma from both tubes within the 6 hours of collection and transfer to ONE Purple Screw-capped tube (2 mL of plasma required).
• Store and transport plasma in the Purple Screw-capped tube at room temperature if transported to the laboratory within 24 hours.
• If transport may be delayed, refrigerate and transport within 3 days. 
• If other tests are required, please draw additional tubes.  To avoid possible contamination, the specimen for Hepatitis C Viral Load testing should not be used for other testing.

PLEASE NOTE:  A minimum of 1.5 mL of plasma in a dedicated tube is required.  If other testing is requested, please submit a separate specimen.

ORDERING :

• Test Name:  HEPATITIS C QUANTITATIVE NUCLEIC ACID AMPLIFIED TEST
• Test Code:  6650008
• Mnemonic:  HEPCNAATQT, PDM number