An evaluation of competitive and second generation ELISA screening tests for antibody to HIV

Maskill, William J.; Crofts, Nick; Waldman, Edward; Healey, David S.; Howard, Teresa; Silvester, Colin; Gust, Ian D.

doi:10.1016/0166-0934(88)90088-2

Cited by 25 publications

(11 citation statements)

References 13 publications

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“…From the sample-by-sample analysis of the individual dilutions, we identified difficulty in the interpretation of the samples mimicking weak reactivity. These dilutions were the least accurately interpreted photographs for all five assays, confirming previous studies (10,18). These samples mimicked weak or nonspecific reactivity, similarly to that occurring during seroconversion or biological false reactivity, but most importantly do not offer information about the sensitivity and specificity of an assay (16).…”

Section: Discussionsupporting

confidence: 74%

Assessing Proficiency of Interpretation of Rapid Human Immunodeficiency Virus Assays in Nonlaboratory Settings: Ensuring Quality of Testing

et al. 2008

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Rapid antibody tests for the detection of human immunodeficiency virus (HIV) offer an effective means of providing a timely result of HIV serostatus to individuals. The increased use of rapid HIV antibody tests outside the laboratory has highlighted the need for new, cost-effective quality assurance methods to be developed for use in nonlaboratory-based and resource-limited settings. Photographed rapid HIV test results were used in a modified external quality assessment scheme to assess the interpretation proficiency and, therefore, to assess the feasibility of using this method as a basis for a quality assessment program for nonlaboratory-based testing. Participants (n ‫؍‬ 148), both experienced and inexperienced in the performance and interpretation of rapid HIV testing, interpreted the photographed results of five rapid HIV assays. These were scored according to the degree of technical discordance. Error scores were grouped according to each participant's technical experience. The accuracy of interpretation for four of the five assays was between 80 and 97%, indicating that the photographed results of samples, including those difficult to read or borderline difficult to read, can be used to assess the proficiency of test operators in interpreting results. Participants had greater difficulty in interpreting samples of weak reactivity; this was consistent across the five assays. Experience played an important role in accurate interpretation, with experienced laboratory participants exhibiting greater proficiency (P < 0.05) in interpreting the results of three of the five rapid HIV assays. It was established that photographed results of rapid HIV assays could be interpreted with accuracy and demonstrated that prior experience resulted in a more accurate interpretation performance.

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Section: Discussionsupporting

confidence: 74%

Assessing Proficiency of Interpretation of Rapid Human Immunodeficiency Virus Assays in Nonlaboratory Settings: Ensuring Quality of Testing

et al. 2008

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“…Since the Nagasaki panel (n ¼ 397) contains both HTLV antibody negative and positive specimens, it is ideal for analyzing the separation between the two populations. The Delta (d) value provides a mathematical method to quantify the degree of separation between positive and negative populations and to correspondingly determine the adequacy of the defined assay CO. A higher absolute value of d correlates with a higher probability that the assay will correctly identify specimens as either antibody positive or negative Maskill et al, 1988]. The ARCHITECT rHTLV-I/II S/CO values of the Nagasaki panel members were log 10 transformed and then the d values were calculated.…”

Section: Assay Sensitivitymentioning

confidence: 99%

Evaluation of a new, fully automated immunoassay for detection of HTLV‐I and HTLV‐II antibodies

Qiu

Hodges

Lukaszewska

et al. 2008

Journal of Medical Virology

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Screening blood donations for human T-lymphotropic virus types I and II (HTLV-I/II) continues to be important in protecting the safety of blood products and controlling the global spread of these retroviruses. We have developed a fully automated, third generation chemiluminescent immunoassay, ARCHITECT rHTLV-I/II, for detection of antibodies to HTLV-I/II. The assay utilizes recombinant proteins and synthetic peptides and is configured in a double antigen sandwich assay format. Specificity of the assay was 99.98% (9,254/9,256, 95% CI = 99.92-100%) with the negative specimens from the general population including blood donors, hospital patients and pregnant women from the US, Japan and Nicaragua. The assay demonstrated 100% sensitivity by detecting 498 specimens from individuals infected with HTLV-I (n = 385) and HTLV-II (n = 113). ARCHITECT rHTLV-I/II results were in complete agreement with the Murex HTLV-I/II reference assay and 99.7% agreement with the Genelabs HTLV Blot 2.4 confirmatory assay. Analytical sensitivity of the assay was equivalent to Murex HTLV-I/II assay based on end point dilutions. Furthermore, using a panel of 397 specimens from Japan, the ARCHITECT rHTLV-I/II assay exhibited distinct discrimination between the antibody negative (Delta Value = -7.6) and positive (Delta Value = 7.6) populations. Based on the excellent specificity and sensitivity, the new ARCHITECT rHTLV-I/II assay should be an effective test for the diagnosis of HTLV-I/II infection and also for blood donor screening.

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“…The inadequacy of these bacterial recombinant N antigens in diagnostic antibody assays contrasts with the situation found using other recombinant viral proteins produced in bacteria, notably in diagnostic assays for antibodies specific for human immunodeficiency virus. Such assays have been found to be at least as efficient as those using conventionally produced antigens (Maskill et al, 1988;Ng et al, 1989).…”

Section: Discussionmentioning

confidence: 99%

Expression of the Lassa Virus Nucleocapsid Protein in Insect Cells Infected With a Recombinant Baculovirus: Application to Diagnostic Assays for Lassa Virus Infection

Barber

Clegg

Lloyd

1990

Journal of General Virology

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An evaluation of competitive and second generation ELISA screening tests for antibody to HIV

Cited by 25 publications

References 13 publications

Assessing Proficiency of Interpretation of Rapid Human Immunodeficiency Virus Assays in Nonlaboratory Settings: Ensuring Quality of Testing

Assessing Proficiency of Interpretation of Rapid Human Immunodeficiency Virus Assays in Nonlaboratory Settings: Ensuring Quality of Testing

Evaluation of a new, fully automated immunoassay for detection of HTLV‐I and HTLV‐II antibodies

Expression of the Lassa Virus Nucleocapsid Protein in Insect Cells Infected With a Recombinant Baculovirus: Application to Diagnostic Assays for Lassa Virus Infection

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