Evolution in the sensitivity of quantitative HIV-1 viral load tests
Section snippets
Background HIV-1 RNA viral load tests
Real-time PCR tests are capable of detecting and quantifying small amounts of nucleic acid. This is especially the case with HIV-1 viral load monitor tests, where the analytical sensitivity of commercial tests is currently as low as 20 copies/mL.1 Nearly two decades ago, Roche Molecular Systems (Pleasanton, CA) HIV-1 viral load tests, the AMPLICOR® HIV-1 MONITOR Test, version 1.5 (which used microwell plates) and later the semi-automated COBAS® AMPLICOR HIV-1 MONITOR Test, version 1.5 (CA-HIM
Analytical considerations
In a given plasma sample from an HIV-1-infected patient, the volume drawn will have various proportions of numbers, “X”, of HIV-1 RNA copies that generate three types of reported test results (Table 3 and Fig. 1). These proportions can be approximated using a Poisson probability distribution describing the probability of having X = 0, 1, 2,… copies in a test sample as a function of the mean number of copies per sample volume in the patient's blood. The random variation of the number of copies in
Conclusions
Advances in technologies will continue to bolster improvements in molecular diagnostics applications, potentially providing a diagnostic tool before it can be well understood clinically. This has been the case with more sensitive tests for HIV-1 RNA viral load monitoring and detecting low levels of HIV-1 RNA without a clear context or supporting data to determine clinical significance. However, more sensitive HIV-1 RNA tests have proved to be useful in research studies to help better understand
Funding source
None.
Ethical approval
Not required.
Conflict of interest
Bryan R. Cobb, Jeffrey E. Vaks, Tri Do, and Regis A. Vilchez are employees of Roche Molecular Systems.
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