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.
For specimen requirements pertaining to collection, shipping and handling, please refer to the test menu option.

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 test is a Real Time RT-PCR assay for human influenza A virus, and the differential detection of 2009 H1N1 influenza virus in nasopharyngeal swabs, nasal swabs, throat swabs and nasal aspirates only.   The sample is to be placed in viral transport media.  Stability is 48 hrs at RT, 7 days refrigerated and 30 days frozen.

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).

The recommendation applies to testing performed at adult and pediatric therapeutic HIV/AIDS clinical trial sites both in the United States and internationally, as well as the centralized network laboratories in the United States.

The Abbott RealTime HIV-1 test is intended for use in conjunction with clinical presentation and other laboratory markers as an indicator of disease prognosis and for use as an aid in assessing viral response to antiretroviral treatment as measured by changes in plasma HIV-1 RNA levels. The assay is not intended to be used as a donor-screening test for HIV-1 or as a diagnostic test to confirm the presence of HIV-1 infection.
 
The report will include both copies/mL and log copies/mL when detected.