PI Perspective #27

April 1999     View PDF     En español

Ultrasensitive PCR Approved

The Food and Drug Administration recently approved the ultrasensitive PCR (polymerase chain reaction) test, which measures the amount of HIV found in blood. This new test is an improvement over the existing test because it can measure the amount of HIV found in blood down to 50 copies of HIV RNA per milliliter of plasma (the liquid part of blood). The older test is only able to measure down to 400 copies per milliliter of plasma.

Several studies have shown that people who are able to suppress HIV levels below 50 copies HIV RNA are more likely to have longer-lasting anti-HIV activity. The ultrasensitive test is considered to give accurate results in people with HIV levels between 50 and 75,000 copies HIV RNA whereas the older test is considered accurate between 400 and 750,000 copies HIV RNA.

Roche Diagnostics, the developers of these two tests, has established a Patient Assistance Program to ensure access to the test for those not covered by insurance or other third-party payers. The program can be reached at 1-888-TEST-PCR.