Ability of TESTPACK ROTAVIRUS enzyme immunoassay to diagnose rotavirus gastroenteritis

Chernesky, Max; Castriciano, Santina; Mahony, James B.; Spiewak, M; Schaefer, Lawrence

doi:10.1128/jcm.26.11.2459-2461.1988

Cited by 13 publications

(5 citation statements)

References 17 publications

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“…1), immune electron microscopy, and isolation. In our hands, TestPack failed to approach the near-perfect test specifications reported by others (3,15). However, our results showing an 83% specificity are more in agreement with those of workers reporting a specificity of 90% (2).…”

Section: Resultssupporting

confidence: 77%

“…The sensitivity of the assay has been found to be satisfactory for the diagnosis of rotavirus gastroenteritis. However, the specificity of TestPack, at selected geographic locations, has been shown to vary from 90 to 100% (2,3,15). The purpose of this study was to investigate the performance of the TestPack in the Long Island, N.Y., area, to identify any recrementitious variability in the specificity of the test.…”

mentioning

confidence: 99%

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Occurrence of nonspecific reactions among stool specimens tested by the Abbott TestPack rotavirus enzyme immunoassay

et al. 1990

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Sixty-five stool specimens obtained from children suffering from gastroenteritis were tested for the presence of antigen to rotavirus by the Abbott TestPack Rotavirus (TestPack) enzyme immunoassay kit. The Kallestad Pathfinder enzyme immunoassay, polyacrylamide gel electrophoresis, immune electron microscopy, and virus isolation were utilized as reference assays. Fifty-four specimens were in accord by TestPack and Kallestad Pathfinder. Among 11 discordant specimens positive with TestPack but negative by Kallestad Pathfinder, rotavirus was not identified by polyacrylamide gel electrophoresis, immune electron microscopy, or isolation in primary African green monkey kidney cell cultures. TestPack displayed a performance specificity of 83%. The inordinately high number of stool specimens reported as false-positive by TestPack precludes the incorporation of this antigen detection kit into our routine regimen of diagnostic virologic testing.

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Section: Resultssupporting

confidence: 77%

mentioning

confidence: 99%

Occurrence of nonspecific reactions among stool specimens tested by the Abbott TestPack rotavirus enzyme immunoassay

et al. 1990

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“…These results are similar to those recently described by Marchlewicz et al, who found an ATR sensitivity of 89%, and a specificity of 88% when testing stools from symptomatic children (10). Chernesky et al also recently described their experience with the use of ATR on stool samples from 172 patients (3). The sensitivity and specificity were both 100% when compared to a standard (DEM and blocking assay) similar to that used in the second part of our study.…”

supporting

confidence: 91%

Comparison of a new rapid test (TestPack Rotavirus) with standard enzyme immunoassay and electron microscopy for the detection of rotavirus in symptomatic hospitalized children

Brooks

Brown

1989

J Clin Microbiol

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We compared a new, rapid, qualitative test for rotavirus (TestPack Rotavirus; Abbott Laboratories, North Chicago, Ill.) with another enzyme immunoassay (Pathfinder Rotavirus; Kallestad Laboratories, Inc., Austin, Tex.) and electron microscopy to determine its clinical utility in a population of symptomatic hospitalized children. In the first part of the study, 100 frozen stool samples were tested. The results after resolution with a blocking reagent showed a sensitivity of only 50% and a specificity of 88% for TestPack Rotavirus. In the second part of the study, we tested TestPack Rotavirus on 100 fresh, unfrozen samples. The results (sensitivity/specificity) were as follows: TestPack Rotavirus, 95/90%; Pathfinder Rotavirus, 84/98%; direct electron microscopy, 63/100%. Although it was not as sensitive or specific as immune electron microscopy, TestPack Rotavirus was more sensitive than direct electron microscopy or Kallestad Pathfinder Rotavirus. TestPack Rotavirus represents a rapid, qualitative method for the detection of rotavirus in stools of symptomatic children.

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“…The choice of a reference standard for the evaluation of rotavirus assays is important in determining the clinical utility of assays and in comparisons of evaluations of assays done in a variety of laboratory settings. Reference standards used in prior evaluations of rotavirus assays have included direct EM (5,6,15,22,24,27), immune EM (2,3,20), solid-phase immune EM (11), polyacrylamide gel electrophoresis of rotaviral RNA (21), a spin-amplified culture with fluorescent focus assay (16), or a reference EIA (8,10,12,19,29).…”

Section: Discussionmentioning

confidence: 99%

Choice of reference assay for the detection of rotavirus in fecal specimens: electron microscopy versus enzyme immunoassay

1990

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Two previously demonstrated sensitive and specific enzyme immunoassays (EIAs) for rotavirus, one using polyclonal and monoclonal antisera (TestPack Rotavirus [TPK]; Abbott Laboratories) and the other using only monoclonal anti-rotavirus antibodies (Rotaclone [RTC]; Cambridge BioScience Corporation), were evaluated as potential reference assays for rotavirus testing in comparison with direct negative-staining electron microscopy (EM), the current laboratory standard. Two hundred and seven stool samples collected consecutively during the winter of 1989 from children with acute diarrhea admitted to a ward for infants from 0 to 2 years of age were tested by the EIAs and by EM. TPK specimens were read visually; RTC results were read spectrophotometrically. Specimens with discordant EIA and EM results were further evaluated by a fluorescent focus assay. Specimens positive by EM and those negative by EM but positive by fluorescent focus assay were considered to be positive for rotavirus. Of the 207 stools tested, 35 (17%) were positive for rotavirus by these criteria. EM had a sensitivity of only 80%. Specificities were 100% for RTC and EM and 89% for TPK. These findings indicate that EM, although very specific, is relatively insensitive compared with a highly sensitive monoclonal antibody-based EIA. An EIA with high sensitivity and specificity, such as RTC, is a more appropriate reference standard for rotavirus testing.

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Ability of TESTPACK ROTAVIRUS enzyme immunoassay to diagnose rotavirus gastroenteritis

Cited by 13 publications

References 17 publications

Occurrence of nonspecific reactions among stool specimens tested by the Abbott TestPack rotavirus enzyme immunoassay

Occurrence of nonspecific reactions among stool specimens tested by the Abbott TestPack rotavirus enzyme immunoassay

Comparison of a new rapid test (TestPack Rotavirus) with standard enzyme immunoassay and electron microscopy for the detection of rotavirus in symptomatic hospitalized children

Choice of reference assay for the detection of rotavirus in fecal specimens: electron microscopy versus enzyme immunoassay

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