Comparison of seven kits for detection of rotavirus in fecal specimens with a sensitive, specific enzyme immunoassay

Abstract

A sensitive, specific enzyme immunoassay (SSEIA) was compared to four commercial, enzyme-linked immunosorbent assay (ELISA) kits and three latex agglutination assay (LAA) kits: (1) Rotavirus EIA, International Diagnostic Laboratories (IDL), (2) Pathfinder, Kallestadt (KAL), (3) Rotavirus Bio-EnzaBead, Litton (LIT), (4) Rotazyme II, Abbott (RTZII), (5) Slidex Rota-Kit, bioMerieux (SRK), (6) Meritec-Rotavirus, Meridian (MER), and (7) Rotalex, Medical Technology Corporation (RLX). The SSEIA was chosen as the reference method due to its greater sensitivity in comparison to immunoelectron microscopy and polyacrylamide gel electrophoreses of viral RNA segments. Upon evaluation of 136 specimens (of which 44 were positive by SSEIA), the ELISA kits (LIT, KAL, IDL, and RTZII) had sensitivities of 80%, 98%, 91% and 84%; specificities of 95%, 78%, 100%, and 88%; positive predictive values (PPV) of 88%, 68%, 100%, and 77%; and negative predictive values (NPV) of 91%, 99%, 96%, and 92%. When compared with SSEIA, the three LAA tests (SRK, MER, and RLX) had sensitivities of 73%, 75%, and 62%; specificities of 99%, 93%, and 95%; PPVs of 97%, 85%, and 84%; and NPVs of 88%, 89%, and 84%. LAA test results appeared to be reliable, if positive, but the sensitivities of these tests were less than those of the ELISA tests. The ELISA tests that employed specimen specific negative controls were superior in minimizing false positive reactions.