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Clinical Updates: March 3, 2010 New Test Release Hepatitis C RNA, Quantitative Real-Time PCR HCCL is pleased to announce the availability of Hepatitis C RNA, Quantitative Real-Time PCR. The detectable limit and reportable range provides the sensitivity needed to detect very low viral loads as well as quantitate levels that are very high.
The
Hepatitis C Quantitative Real Time PCR assay is an in vitro reverse
transcription-polymerase chain reaction (RT-PCR) assay for the
quantitation of the Hepatitis C virus on the automated m2000 System in
human plasma from HCV infected individuals over the range of 12 to
10,000,000 IU/mL or 1.1-7.00 Log IU/mL. The HCV Real Time PCR assay is
intended for use in conjunction with clinical presentation and other
laboratory markers for disease prognosis and for use as an aid in
assessing viral response to antiretroviral treatment as measured changes
in plasma HCV RNA levels. This assay is not intended to be used as a
donor screening test for HCV or as a diagnostic test to confirm the
presence of HCV infection. Influenza A H1N1 (2009) Test HealthCare
Clinical Laboratories is pleased to announce the availability of the
Novel H1N1 Influenza Virus and the HIV 1 RNA Quantitation
Abbott RealTime PCR assay. The assay provides two test results. One result is for the detection of the seasonal influenza A virus and the other result is for the Novel 2009 H1N1 influenza virus in the specimen. Testing is currently performed Monday through Friday, with plans to increase frequency soon. The kit is Authorized by the FDA for Emergency Use, for the 2009 Influenza season only. Testing with the 2009 H1N1 kit should not be performed unless the patient meets clinical and epidemiologic criteria for testing suspect specimens. Abbott RealTime HIV-1 Test Based on several published studies, current molecular or PCR based diagnostic tests vary in their ability to detect and reliably quantify variant strains of HIV-1 and have been found to under-quantify them. As such HCCL is adopting the Abbott RealTime HIV-1 assay because of this assays demonstrated ability to detect and measure diverse group M subtypes of HIV-1 including all known non-B subtypes, as well as group M, N and O isolates. Also, the Abbott
RealTime HIV-1 Assay and Abbott m2000 System have been
recommended as a standard protocol for viral load testing in
HIV/AIDS clinical trials sponsored by the National Institutes of
Health (NIH).
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