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

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.

Distribution of Rotavirus VP4 Genotypes and VP7 Serotypes among Nonhospitalized and Hospitalized Patients with Gastroenteritis and Patients with Nosocomially Acquired Gastroenteritis in Austria

“…We found that the ELISA was false positive for 12% of the samples compared to the results of RT-PCR. Similar rates of false-positive results for samples tested by the TestPack ELISA were described by Lipson et al (17).…”

Increased detection of rotavirus using a real time reverse transcription‐polymerase chain reaction (RT‐PCR) assay in stool specimens from children with diarrhea

“…Enzyme immunoassays (EIA) detecting viral antigen represent an alternate diagnostic method and have been used as an endpoint assessment in the efficacy trials of rotavirus vaccine [Rennels et al, 1996;Joensuu et al, 1997;Perez-Schael et al, 1997]. While EIA assay is 10-100 times more sensitive than EM, there is variability of the sensitivity and specificity of the EIA assays [Dennehy et al, 1988;Lipson et al, 1990Lipson et al, , 2001Rabenau et al, 1998]. Molecular methods utilizing reverse transcription-polymerase chain reaction (RT-PCR) have increased the rate of detection of rotaviruses by 15-27% in comparison with EIA [Xu et al, 1990;Gouvea et al, 1991;Wilde et al, 1992;Pang et al, 1999].…”

Outbreaks of food-borne and waterborne viral gastroenteritis.

“…EIAs for rotavirus are widely used by clinical laboratories (21). Several studies comparing the performances of these assays with virus isolation have demonstrated test sensitivities of 70 to 100% and test specificities of 50 to 100% (21,22,83). Problems with false-positive test results have led to recommendations to avoid use of specific test kits and to perform other confirmatory tests when situations in which rotavirus is not a common diagnosis are being evaluated (83).…”