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Guidelines for laboratory test result reporting of human immunodeficiency virus type 1 ribonucleic acid
Insights
Standardized reporting guidelines for human immunodeficiency virus type 1 (HIV-1) ribonucleic acid levels (viral load) are essential. These guidelines ensure consistent and accurate HIV viral load test results for patient care and public health reporting.
Area of Science:
- Virology
- Public Health
- Clinical Laboratory Science
Background:
- Monitoring human immunodeficiency virus type 1 (HIV-1) ribonucleic acid levels, or viral load, is standard for assessing HIV treatment efficacy.
- The increasing use of viral load testing by public and private laboratories since 1996 has highlighted variability in test methods and result reporting.
Framework:
- Development of standardized reporting guidelines for HIV viral load test results.
- Guidelines aim to promote uniformity in how licensed laboratories report test outcomes to healthcare providers and facilities.
Implementation:
- Standards were established through data review, expert working groups, and laboratory practice assessments.
- Guidelines were discussed, refined, and endorsed at the Human Retrovirus and Hepatitis C Laboratory Testing Conference in March 2000.
Implications:
- Adoption by all laboratories performing HIV viral load testing will enhance result quality and utility.
- Standardized reporting improves data for physicians managing HIV-infected patients and for public health surveillance of HIV infection and AIDS.
Abstract:
Monitoring human immunodeficiency virus type 1 (HIV-1) ribonucleic acid levels (also known as HIV viral load) has become the standard of care for monitoring response to therapy in HIV-infected patients. In 1999, CDC published updated surveillance case definitions for HIV infection and acquired immunodeficiency syndrome (AIDS) reporting, including positive results of HIV-1 viral detection tests (CDC. Guidelines for national human immunodeficiency virus case surveillance, including monitoring for human immunodeficiency virus infection and acquired immunodeficiency syndrome. MMWR 1999;48[No. RR-131:1-28). Since 1996, an increased number of public and private laboratories have begun performing viral load tests. Results obtained with available test methods are variable, and laboratories present these results in different ways, indicating that guidelines to promote standard practice in reporting of test results are warranted. This report provides guidelines for standardized reporting of viral load test results by licensed laboratories to health-care providers and facilities for public health case reporting of HIV infection and AIDS. Recommended standards were developed through data review, input involving a working group of physicians and laboratorians experienced in viral load testing, and an assessment of laboratory practices. These guidelines were discussed, refined, and endorsed at the annual Human Retrovirus and Hepatitis C Laboratory Testing Conference, held March 6-9, 2000, in Charlotte, North Carolina, with participation of representatives from public health, hospital, independent, and blood-collection-facility laboratories. Adoption of these guidelines by all public and private laboratories that perform HIV viral load testing will improve the quality and usefulness of viral load test results for the physician ordering the test and for reporting to public health departments.
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