Occurrence of nonspecific reactions among stool specimens tested by the Abbott TestPack rotavirus enzyme immunoassay
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Published on: July 22, 2012
S M Lipson1, G P Leonardi, R J Salo
1Department of Pathology and Laboratories, Nassau County Medical Center, East Meadow, New York 11554.
Insights
The Abbott TestPack Rotavirus assay showed low specificity, with many false-positive results for rotavirus antigen in children's stool samples. This limits its use in routine diagnostic testing for gastroenteritis.
Area of Science:
- Clinical Virology
- Diagnostic Assay Evaluation
- Pediatric Infectious Diseases
Background:
- Gastroenteritis in children is frequently caused by rotavirus.
- Accurate and rapid diagnostic tests are crucial for patient management and epidemiological studies.
Purpose of the Study:
- To evaluate the diagnostic performance of the Abbott TestPack Rotavirus enzyme immunoassay kit.
- To compare the TestPack assay with established reference methods for rotavirus antigen detection.
Main Methods:
- Sixty-five stool specimens from children with gastroenteritis were tested using the Abbott TestPack Rotavirus kit.
- Reference assays included Kallestad Pathfinder enzyme immunoassay, polyacrylamide gel electrophoresis, immune electron microscopy, and virus isolation.
Main Results:
- The TestPack assay showed agreement with the Kallestad Pathfinder assay in 54 specimens.
- Eleven specimens were positive by TestPack but negative by reference methods.
- The TestPack assay demonstrated a specificity of 83%, with a high rate of false-positive results.
Conclusions:
- The Abbott TestPack Rotavirus assay exhibits poor specificity, leading to a significant number of false-positive results.
- The high false-positive rate precludes the use of this kit in routine diagnostic virologic testing for rotavirus in this setting.
Abstract:
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.
