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March 12, 1997

Performance Evaluation Programs for Determining HIV-1 Viral Loads, Testing for HIV p24 Antigen, and Identifying Mycobacterium tuberculosis Using Nucleic Acid Amplification Tests

JAMA. 1997;277(10):786. doi:10.1001/jama.1997.03540340020012

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CDC's Division of Laboratory Systems, Public Health Practice Program Office, is implementing three new laboratory performance evaluation (PE) programs. The first assesses the performance of laboratories that perform tests to determine the viral RNA copy number (viral load) in the blood of persons infected with human immunodeficiency virus type 1 (HIV-1); the second assesses the performance of laboratories that perform HIV p24 antigen (Ag) testing; and the third assesses the performance of laboratories that perform nucleic acid amplification (NAA) tests for Mycobacterium tuberculosis.

Results of viral load determinations are being used by physicians treating HIVinfected patients to make decisions regarding initiation of antiretroviral therapy and to determine whether current antiretroviral therapy is effective or whether changes in antiretroviral therapy should be implemented based on the amount of virus in the blood of HIV-infected patients.1-4 In June 1996, the Food and Drug Administration (FDA) approved a reverse-transcriptase polymerase chain