HIV ELISA Test – Vironostika

The Standard HIV Test. The whole thing is worth a deep read, goat-serum, cross-reactivity and all.

Some annotated excerpts:

SUMMARY AND EXPLANATION OF THE TEST

Published data indicate a strong correlation between the acquired immunodeficiency syndrome (AIDS) and a retrovirus referred to as Human Immunodeficiency Virus (HIV).”

“Currently, two HIV serotypes, designated as HIV-1 and HIV-2, have been identified based on the results of serologic and molecular studies. Both HIV serotypes have been isolated from patients with AIDS and AIDS-related complex (ARC), as well as from apparently healthy individuals at high risk for AIDS.”

“A majority of patients who exhibit symptoms of AIDS or ARC have HIV specific antibodies in their blood. In addition, a significant proportion of apparently healthy individuals at increased risk for AIDS also contain HIV specific antibodies in their blood specimens.”

“The Vironostika HIV-1 Plus O Microelisa System assay was designed to be highly sensitive for a spectrum of HIV-1 serotypes, including group O virus. As a result, nonspecific reactions may occasionally be seen in specimens from people who have prior pregnancy, blood transfusion, or exposure to human cells or media containing cultured HIV antigen.”

Because of these and other potential nonspecific reactions, specimens reactive with the Vironostika HIV-1 Plus O Microelisa System assay should be confirmed with a confirmatory test ,e.g., Western Blot.”

“Reactive specimens upon initial testing with the Vironostika HIV-1 Plus O Microelisa System assay should be re-tested in duplicate.”

“Reactivity in either or both of the duplicate tests indicates a potential for the presence of HIV-specific antibody.”

“In individuals at increased risk of infection, such as homosexual men, hemophiliacs, or intravenous drug users, repeatedly reactive specimens are usually found to contain antibodies to HIV by additional, more specific tests.”

“However, when the ELISA is used to screen populations with a low prevalence of HIV infections, nonspecific reactions may be more common than specific reaction.”

“Information about prevalence of HIV infections in persons in various categories of risk, as well as clinical and public health guidelines, are available in each CDC publication of Morbidity and Mortality Weekly Reports.”

“Although information about the degree of risk for HIV-1 infection and the degree of reactivity of the serum are of value in interpreting the test, a diagnosis should not be based only on this information.”

“Therefore, it is appropriate to investigate repeatedly reactive specimens by additional, more specific tests, such as Western Blot, immunofluorescence, radioimmunoprecipitation, viral antigen based immunoassays, peptide ELISAs, or nucleic acid amplification assays.”

High-risk populations:

To assess the performance of the test with specimens collected from high-risk populations, fifteen hundred and fourteen (1,514) specimens were collected from four high-risk populations, which included prison inmates, STD (sexually transmitted diseases) clinic patients, inner city hospital emergency room patients, and HIV-1 outreach clinic patients.”

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