Are current rapid detection tests for Group A Streptococci sensitive enough? Evaluation of 2 commercial kits

Scand J Infect Dis. 2002;34(11):797-9. doi: 10.1080/0036554021000026953.

Abstract

A new, 1-step, enzyme-linked immunoassay kit for detection of Group A Streptococci (GAS) in throat samples (QuickVue In-Line One-Step Strep A Test; Quidel Corporation, San Diego, CA) was evaluated for use in a study comprising 536 patients in 8 primary healthcare centres. Compared to conventional culture at the clinical microbiology laboratory, the sensitivity achieved was 73.9% and the specificity 86.8%; these figures were not affected to any major extent by broth enrichment of samples before culturing or following PCR testing of the cysteine proteinase gene for independent diagnosis of GAS. It was also found that most samples containing low numbers of GAS were missed by the rapid test. We therefore evaluated the kit in use in our area (TestPack Plus Strep A Test; Abbott Laboratories, Chicago, IL) in a separate study of 615 patients. Somewhat increased sensitivity (82.8%) and specificity (96.1%) were obtained. As current antigen tests depend on subjective judgement of test outcome, improvements in test design or provision of more detailed instructions may be desirable in order to achieve optimal results.

Publication types

  • Comparative Study
  • Evaluation Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Antigens, Bacterial / analysis
  • Child
  • Enzyme-Linked Immunosorbent Assay / methods*
  • Enzyme-Linked Immunosorbent Assay / standards
  • Female
  • Humans
  • Male
  • Middle Aged
  • Pharyngitis / diagnosis
  • Reagent Kits, Diagnostic / standards*
  • Sensitivity and Specificity
  • Streptococcal Infections / diagnosis*
  • Streptococcus / classification*
  • Streptococcus / isolation & purification*
  • Tonsillitis / diagnosis

Substances

  • Antigens, Bacterial
  • Reagent Kits, Diagnostic