Abstract
Sensitivity and specificity of rapid antigen detection tests (RADTs) for detection of group A hemolytic streptococcus (GAS) vary. The purpose is to present the first SKUP (Scandinavian evaluation of laboratory equipment for point of care testing) evaluations concerning the assessment of the diagnostic performance and user-friendliness of two RADTs for detection of GAS when used under real-life conditions in primary health care. Throat samples were collected in duplicates at primary health care centers (PHCCs) from patients with symptoms of pharyngitis. The performance of QuickVue Dipstick Strep A test (307 samples) and DIAQUICK Strep A Blue Dipstick (348 samples) was evaluated using culture results at a clinical microbiology laboratory as comparison. The user-friendliness was evaluated using a questionnaire. The diagnostic sensitivity was 92% (90% confidence interval (CI) 87–96%) and 72% (90% CI 65–79%), while the diagnostic specificity was 86% (90% CI 81–90%) and 98% (90% CI 96–99%) for QuickVue Dipstick Strep A test and DIAQUICK Strep A Blue Dipstick, respectively. Both RADTs obtained acceptable assessments for user-friendliness and fulfilled SKUP’s quality goal for user-friendliness. The diagnostic sensitivity for QuickVue Dipstick Strep A test and the diagnostic specificity for DIAQUICK Strep A Blue Dipstick in this objective and supplier-independent evaluation were higher compared with previous meta-analyses of RADTs. However, the diagnostic specificity for QuickVue Dipstick Strep A test and the diagnostic sensitivity for DIAQUICK Strep A Blue Dipstick were lower compared with previous meta-analyses of RADTs.
Highlights
Group A hemolytic streptococcus (Streptococcus pyogenes; S. pyogenes) (GAS) is the most frequent bacterial cause of infectious pharyngitis
This paper presents the first SKUP evaluations concerning the assessment of the diagnostic accuracy performance and user-friendliness of two rapid antigen detection tests (RADTs) for group A hemolytic streptococcus (GAS), QuickVue Dipstick Strep A test and DIAQUICK Strep A Blue Dipstick, when used under real-life conditions by the intended users in primary health care
Consecutive patients with severe symptoms of pharyngitis seeking care in primary health care centers (PHCCs) in Skåne county (Sweden) were asked if they were willing to participate in the study
Summary
Group A hemolytic streptococcus (Streptococcus pyogenes; S. pyogenes) (GAS) is the most frequent bacterial cause of infectious pharyngitis. Common signs and symptoms of the disease include sore throat, fever, tonsillar exudates, and swollen cervical lymph nodes. The Norwegian guidelines for primary health care on streptococcal pharyngitis recommend using rapid antigen detection tests (RADTs) for GAS in patients fulfilling at least two of the four Centor criteria (fever, anterior cervical lymphadenopathy, tonsillar rubor and exudates, and lack of cough) [3, 4]. In the Danish guidelines, two or more of the modified Centor criteria [5] must be fulfilled [6], while the Swedish guidelines recommend usage of RADTs upon clinical suspicion of bacterial pharyngitis and fulfillment of three or four Centor criteria [7]. Antibiotics are recommended if positive RADT [4, 6, 7]
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