Clinical evaluation of the sensitivity and specificity of a commercially available enzyme immunoassay for detection of rubella virus-specific immunoglobulin M

Chernesky, Max; Wyman, Leland C.; Mahony, James B.; Castriciano, Santina; Unger, John T.; Safford, J W; Metzel, Peyton

doi:10.1128/jcm.20.3.400-404.1984

Cited by 25 publications

(8 citation statements)

References 25 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…In this study, subpassage yielded five additional isolates. While it has been suggested that the order of sample collection may affect test results (7, 10), our findings are consistent with those of other studies that have shown the swab order not to be a significant factor (3,6,20,22). Chi-square analysis showed that the swab order did not adversely affect the outcome of either nonculture assay (data not shown).…”

Section: Discussionsupporting

confidence: 92%

Comparison of the Syva MicroTrak enzyme immunoassay and Gen-Probe PACE 2 with cell culture for diagnosis of cervical Chlamydia trachomatis infection in a high-prevalence female population

et al. 1993

View full text Add to dashboard Cite

Culture is currently considered the "gold standard" for detecting Chiamydia trachomatis infections. We evaluated the Syva MicroTrak enzyme immunoassay (EIA) and Gen-Probe PACE 2 tests, which detect chlamydial antigens and rRNA, respectively. These assays were compared with each other and with culture for the detection of C. trachomatis in cervical specimens obtained from 217 women attending a clinic for sexually transmitted diseases. The prevalence of infection was 22.1% by culture. The sensitivity, specificity, and positive and negative predictive values were 79.2, 98.2, 92.6, and 94.3%, respectively, for EIA. For PACE 2, the respective values were 77.1, 97.6, 90.1, and 93.7%. After corrections for two false-negative cultures, the sensitivities and specificities were 80 and 99.4%, respectively, for the EIA and 78 and 98.8%, respectively, for the probe assay. Quantitative evaluation of the results showed that false-negative results with either assay were associated with cultures that had low inclusion counts or were negative without subpassage. Analysis of nonculture results revealed that 2.3% of the EIA results and 4.6% of the probe assay results were within ±30%o of the respective assay cutoff values. These included four false-negative (one EIA and three probe) and two false-positive (one EIA and one probe) results. The Syva MicroTrak EIA and the Gen-Probe PACE 2 assay are comparable to but significantly less sensitive than culture. Use of a grey zone may help identify the need for repeat or confirmatory testing.

show abstract

Section: Discussionsupporting

confidence: 92%

Comparison of the Syva MicroTrak enzyme immunoassay and Gen-Probe PACE 2 with cell culture for diagnosis of cervical Chlamydia trachomatis infection in a high-prevalence female population

et al. 1993

View full text Add to dashboard Cite

show abstract

“…As per WHO standards, Rubella IgG titers of 10 IU/mL was considered as positive and a pregnant woman was presumed to be naturally immune; whereas the index value of 1.1 was considered Rubella IgM seropositive signifying recent or acute infection as per manufacturer guidelines. The sensitivity and specificity of IgG ELISA used was >99% (Field et al, 1988;Rawls and Chernesky, 1976) while for IgM, sensitivity was 97.6% with specificity of 99.3% (Chernesky et al, 1984). Randomly selected 300 positive samples and 30 negative samples were re-tested at Institute of Microbiology Gottingen, Germany using AxSYM rubella virus IgG/IgM-MEIA (Abbott, IL, USA) as quality control.…”

Section: Detection Of Rubella Antibodiesmentioning

confidence: 99%

Adverse pregnancy outcomes among pregnant women with acute Rubella infections in Mwanza city, Tanzania

Mirambo

Aboud

Majigo

et al. 2019

International Journal of Infectious Diseases

View full text Add to dashboard Cite

Objective: This study investigated the adverse pregnancy outcomes among pregnant women with acute Rubella infections in the city of Mwanza, Tanzania. Methods: A longitudinal study was conducted between 2014 and 2016 among pregnant women attending antenatal clinics. Women were screened for Rubella IgG and IgM antibodies using enzyme immunoassay (EIA). IgM seropositive pregnant women were followed up until the end of the pregnancy to determine Congenital Rubella Syndrome, congenital infections and other pregnancy outcomes. Results: The median age of 685 enrolled pregnant women was 23 (IQR: 19-27) years. A total of 629(91.8%) were Rubella IgG seropositive while 61 (8.9%) were IgM seropositive. The IgM seropositivity was found to decrease significantly from first trimester to third trimester, p < 0.001. Forty six (83.6%) of 55 Rubella IgM seropositive women had adverse pregnancy outcomes and 6 (10.9%) delivered neonates with CRS, making the overall incidence of CRS to be 6/685 (0.87%). First trimester IgM seropositive women had significantly higher adverse pregnancy outcomes than those in second/third trimesters (70.4% vs. 35.7, p = 0.01).Conclusion: There is one case of CRS in every 100 pregnancies necessitating additional strategies to reach a goal of elimination of CRS in developing countries.

show abstract

“…Untreated sera were assayed, and the ratio of the absorbance of the test serum to that of the control in the kit yielded an index which was a quantitative result. A Rubazyme index greater than 1.0 indicates the presence of rubella IgM antibody (5). All specimens in the analysis yielded an index above 1.1 Agglutination assays.…”

Section: Methodsmentioning

confidence: 94%

Differences in antibody responses with rapid agglutination tests for the detection of rubella antibodies

Chernesky¹,

DeLong²,

Mahony³

et al. 1986

J Clin Microbiol

Self Cite

View full text Add to dashboard Cite

Rapid agglutination tests (Rubaquick, Rubascan, and Rubacell) were used to screen sera (374 from immune and 124 from susceptible patients) for rubella immunity. Compared with enzyme immunoassay (Rubazyme) the erythrocyte agglutination assays (Rubaquick and Rubacell) were greater than 98% sensitive and 92 to 96% specific. The latex test (Rubascan) was sensitive (97.8%) and specific (96.8%) on undiluted serum but only 68.7% sensitive on serum diluted 1:10. Although the three rapid assays detected a substantial number of positive sera within 3 months of rubella immunization, a large number of variable responses were seen after infection with rubella. Analysis of discordant results suggests that these tests may be effectively used for immunity screening. The different individual assay results observed on low-titered sera or blood collected shortly after infection or immunization may not be comparable, because each assay has a different antigenic component on the agglutinin.

show abstract

Clinical evaluation of the sensitivity and specificity of a commercially available enzyme immunoassay for detection of rubella virus-specific immunoglobulin M

Cited by 25 publications

References 25 publications

Comparison of the Syva MicroTrak enzyme immunoassay and Gen-Probe PACE 2 with cell culture for diagnosis of cervical Chlamydia trachomatis infection in a high-prevalence female population

Comparison of the Syva MicroTrak enzyme immunoassay and Gen-Probe PACE 2 with cell culture for diagnosis of cervical Chlamydia trachomatis infection in a high-prevalence female population

Adverse pregnancy outcomes among pregnant women with acute Rubella infections in Mwanza city, Tanzania

Differences in antibody responses with rapid agglutination tests for the detection of rubella antibodies

Contact Info

Product

Resources

About