[Performance Assessment of a Newly Developed Rapid Diagnostic Reagent for Human Immunodeficiency Virus].

Extremely early diagnosis of human immunodeficiency virus (HIV) infection has been considered highly important for its treatment. We conducted a performance assessment of a newly developed rapid diagnostic reagent for HIV by using a fourth-generation immunochromatographic assay (Alere HIV Combo). We used whole-blood, plasma, and serum samples obtained from 250 Japanese adults who visited the Kawasaki Medical School Hospital and underwent HIV screening tests. We also used 12 types of commercial HIV-1 sero- conversion panels and World Health Organization standard antigens. This method, which has a detection sensitivity of 100% and a specificity of 99.3%, was as accurate as the chemiluminescent immunoassay (CLIA) method. In a sensitivity test using seroconversion panels in the early phase of infection, the mean duration until positive conversion was 19.3 days. With this method having a high detection sensitivity for HIV-1p24 antigen, the results from whole-blood samples were the same as those from plasma and serum samples. Therefore, it can be considered as a useful rapid measurement method for general practice.

Assessment of biological reagents for presence of human immunodeficiency virus-1 (HIV-1) antigens.

We tested 122 biological reagents including laboratory quality assurance sera and therapeutic human immune serum globulin products using an immunoenzymometric assay (IEMA) for HIV-1 antigens. Biological reagents tested were 64 HIV-1 antibody non-reactive and 44 HIV-1 antibody reactive quality assurance samples, and 14 HIV-1 antibody reactive human immune serum globulins from 21 manufacturers. Twenty-one of these biological reagents were previously reported by us as Western blot reactive. All 122 samples tested were non-reactive for HIV-1 antigens. Low incidence of HIV-1 antigen in these biological reagents should not alter laboratory safety practices in which all samples are considered infectious. Use of HIV-1 antigen measurements, either alone or with HIV-1 antibody determinations does not increase the likelihood of detecting HIV-1 reactive samples.

Prevalence of human immunodeficiency virus type 1 p24 antigen in U.S. blood donors--an assessment of the efficacy of testing in donor screening. The HIV-Antigen Study Group.

BACKGROUND: We performed a multicenter study in 1989 to determine whether screening whole-blood donors for human immunodeficiency virus type 1 (HIV-1) p24 antigen would improve transfusion safety by identifying carriers of the virus who are seronegative for HIV-1 antibody. METHODS: More than 500,000 donations were tested at 13 U.S. blood centers with test kits from two manufacturers. Units found repeatedly reactive were retested in a central laboratory; if the results were positive, they were confirmed by a neutralization assay. A subgroup of units was also tested for HIV-1 by the polymerase chain reaction. Selected donors confirmed or not confirmed as having p24 antigen were contacted for follow-up interviews to identify risk factors and undergo retesting for HIV-1 markers. RESULTS: Positive tests for p24 antigen were confirmed by neutralization in five donors (0.001 percent of all donations tested), all of whom were also positive for HIV-1 antibody and HIV-1 by polymerase chain reaction. Three of the antigen-positive donors had other markers of infectious disease that would have resulted in the exclusion of their blood; two had risk factors for HIV-1 that should have led to self-exclusion. Of 220 blood units with repeatedly reactive p24 antigen whose presence could not be confirmed by neutralization (0.04 percent of the donations studied), none were positive for HIV-1 antibody, HIV-1 by polymerase chain reaction (120 units tested), or virus culture (76 units tested)--attesting to the specificity of confirmatory neutralization. CONCLUSIONS: The finding that no donation studied was positive for p24 antigen and negative for HIV-1 antibody suggests that screening donors for p24 antigen with tests of the current level of sensitivity would not add substantially to the safety of the U.S. blood supply.

Assessment by gene amplification and serological markers of transmission of HIV-1 from hemophiliacs to their sexual partners and secondarily to their children.

The transmission of HIV-1 infection from men with hemophilia A to their female sex partners and secondarily to their children was studied by serological markers including antibody, antigen, and HIV genome as detected by the polymerase chain reaction (PCR). Among 27 sex partners of 26 seropositive hemophiliacs, 5 were seropositive-PCR positive (active), 11 were seronegative-PCR positive (latent), and 11 were negative for both. These results were confirmed by testing serial serum samples and paired samples of DNA from peripheral blood mononuclear cells (PBMCs) and serum from seronegative women. PCR negativity in exposed women was correlated with the use of condoms (p less than 0.01). Eight children from five couples were seronegative. However, HIV-1 infection as detected by PCR was transmitted to 60% of exposed children, including one from a seronegative-PCR positive mother.

A model for estimating incremental benefits and costs of testing donated blood for human immunodeficiency virus antigen (HIV-Ag).

We propose a model for estimating the benefit of adding a test for the human immunodeficiency virus antigen (HIV-Ag) to current procedures for testing donated blood. Using this model, data on HIV infection from published studies, and certain assumptions about blood donor behavior, we estimate that the probability of detecting an additional HIV-infective blood component is approximately 1 in 4,860,000. If this estimate is correct, adding HIV-Ag testing would prevent approximately 4 cases of primary transfusion-transmitted HIV infection annually in the United States. After adjustments for the median incubation period for AIDS, and for mortality due to primary illnesses, this estimate represents prevention of approximately 1 case of AIDS per year, within the 4 years after transfusion. A primary advantage of this model is its adaptability for recalculating cost-benefit analyses if more sensitive tests for HIV infection become available. In addition, we propose that comparing the anticipated costs and benefits of HIV-Ag testing to other possible uses of these funds should be an important factor in assessing the desirability of HIV-Ag testing.

Avidin-biotin enhanced reverse passive hemagglutination method for detection of HIV antigens.

A new assay for HIV antigens, the avidin-biotin enhanced reverse passive hemagglutination (AB RPHA) test is described which is suitable for detection of infection in cell culture experiments. This assay is simple to perform and economical, and has sensitivity equal to or greater than that of commercial ELISA assays. The coated red cells used for this assay may be stored in the frozen or lyophilized state.