Early HIV and Hepatitis C disease testing

Early HIV and Hepatitis C disease testing

HIV/HBV/HCV Multiplex by PCR

HIV and Hepatitis C Early Detection Screen

Introducing real-time PCR testing to detect:

HIV type 1 (Groups M & O)

HIV type 2 (RNA)

Hepatitis B virus (HBV DNA)

Hepatitis C virus (HCV RNA)

in a single automated multiplex assay (simultaneous reporting). Nucleic acid amplification technologies (NAT) allow for more specific detection of active infections in blood earlier than conventional serology tests are able.

Early Detection of HIV by PCR at 10 days post exposure for HIV I/II and HCV and 24 days before detection of HBsAg by enzyme. Performance: The AMPLINAT MPX HIV and Hepatitis C testing assay has a diagnostic sensitivity of 99.8% and specificity of 99.85%.

Summary and explanation of the screening test

The Roche COBAS TaqScreen MPX Test is a qualitative multiplex test that enables simultaneous screening of HIV-1 Group M and Group O RNA, HIV-2 RNA, HCV RNA and HBV DNA in pooled and individual plasma donations. The cobas TaqScreen MPX Test does not discriminate which virus is detected in a specimen. Results are reported as either NOT DETECTED or DETECTED. Positive findings are immediately reflexed for individual CONFIRMATORY testing using the Roche COBAS AmpliScreen HIV-1 Test, v1.5, COBAS AmpliScreen HCV Test, v2.0 and COBAS AmpliScreen HBV Test for viral target identification (Discriminatory Testing) of HIV-1 Group M, HCV and HBV*, as follows:-

HIV = 20 HIV-1 RNA cp/ml to 1.00E+07 cp/ml

Hep C= 15 HCV RNA IU/ml to 6.90E+07 IU/ml

Hep B = 20 HBV DNA IU/ml to 1.70E+08 IU/ml

In addition, we are now able to add syphilis to the testing system looking for syphilis IgG and IgM.

A negative HIV and Hepatitis C early detection test at 7 days or more carries an overall accuracy of greater than 99.8%.

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