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Review
. 2016 Jul 4;7(7):CD010502.
doi: 10.1002/14651858.CD010502.pub2.

Rapid Antigen Detection Test for Group A Streptococcus in Children With Pharyngitis

Affiliations
Free PMC article
Review

Rapid Antigen Detection Test for Group A Streptococcus in Children With Pharyngitis

Jérémie F Cohen et al. Cochrane Database Syst Rev. .
Free PMC article

Abstract

Background: Group A streptococcus (GAS) accounts for 20% to 40% of cases of pharyngitis in children; the remaining cases are caused by viruses. Compared with throat culture, rapid antigen detection tests (RADTs) offer diagnosis at the point of care (within five to 10 minutes).

Objectives: To determine the diagnostic accuracy of RADTs for diagnosing GAS in children with pharyngitis. To assess the relative diagnostic accuracy of the two major types of RADTs (enzyme immunoassays (EIA) and optical immunoassays (OIA)) by indirect and direct comparison.

Search methods: We searched CENTRAL, MEDLINE, EMBASE, Web of Science, CDSR, DARE, MEDION and TRIP (January 1980 to July 2015). We also conducted related citations tracking via PubMed, handsearched reference lists of included studies and relevant review articles, and screened all articles citing included studies via Google Scholar.

Selection criteria: We included studies that compared RADT for GAS pharyngitis with throat culture on a blood agar plate in a microbiology laboratory in children seen in ambulatory care.

Data collection and analysis: Two review authors independently screened titles and abstracts for relevance, assessed full texts for inclusion, and carried out data extraction and quality assessment using the QUADAS-2 tool. We used bivariate meta-analysis to estimate summary sensitivity and specificity, and to investigate heterogeneity across studies. We compared the accuracy of EIA and OIA tests using indirect and direct evidence.

Main results: We included 98 unique studies in the review (116 test evaluations; 101,121 participants). The overall methodological quality of included studies was poor, mainly because many studies were at high risk of bias regarding patient selection and the reference standard used (in 73% and 43% of test evaluations, respectively). In studies in which all participants underwent both RADT and throat culture (105 test evaluations; 58,244 participants; median prevalence of participants with GAS was 29.5%), RADT had a summary sensitivity of 85.6%; 95% confidence interval (CI) 83.3 to 87.6 and a summary specificity of 95.4%; 95% CI 94.5 to 96.2. There was substantial heterogeneity in sensitivity across studies; specificity was more stable. There was no evidence of a trade-off between sensitivity and specificity. Heterogeneity in accuracy was not explained by study-level characteristics such as whether an enrichment broth was used before plating, mean age and clinical severity of participants, and GAS prevalence. The sensitivity of EIA and OIA tests was comparable (summary sensitivity 85.4% versus 86.2%). Sensitivity analyses showed that summary estimates of sensitivity and specificity were stable in low risk of bias studies.

Authors' conclusions: In a population of 1000 children with a GAS prevalence of 30%, 43 patients with GAS will be missed. Whether or not RADT can be used as a stand-alone test to rule out GAS will depend mainly on the epidemiological context. The sensitivity of EIA and OIA tests seems comparable. RADT specificity is sufficiently high to ensure against unnecessary use of antibiotics. Based on these results, we would expect that amongst 100 children with strep throat, 86 would be correctly detected with the rapid test while 14 would be missed and not receive antibiotic treatment.

Conflict of interest statement

Jérémie F Cohen: None known. Robert Cohen: My relevant financial activities are only in the field of vaccines. Martin Chalumeau: No financial competing interest. Potential academic competing interest (as any expert in the field). Nathalie Bertille: I am supported by educational grants from Laboratoires Guigoz ‐ Société Française de Pédiatrie ‐ Groupe de Pédiatrie Générale ‐ Groupe de Recherches Epidémiologiques en Pédiatrie and Ecole Doctorale 393 (Sorbonne Universités, UPMC Univ Paris 06) and I have no patents, products in development or marketed products to declare. JFC, RC and MC have been involved in studies that were included in the review.

Figures

1
1
Flow diagram of studies in the review. *Studies awaiting classification (n = 14)
2
2
Risk of bias and applicability concerns graph: review authors' judgements about each domain across all included study cohorts (n = 116).
3
3
Risk of bias and applicability concerns summary: review authors' judgements about each domain for each included study cohort (n = 116).
4
4
Forest plots of RADT sensitivity and specificity for GAS detection, ordered by commercial kit. TP = True Positive; FP = False Positive; FN = False Negative; TN = True Negative.
5
5
Summary ROC plot of RADT sensitivity and specificity for GAS detection (n = 105). Each individual study cohort is represented by an empty circle. The filled circle is the pooled summary estimate for sensitivity and specificity. The solid curve represents the 95% confidence region around the summary estimate; the dashed curve represents the 95% prediction region.
6
6
Summary ROC plot of RADT sensitivity and specificity for GAS detection: EIA (n = 86) versus OIA (n = 19). The filled black circle is the pooled summary estimate for sensitivity and specificity of EIA tests; the filled red circle is the pooled summary estimate for sensitivity and specificity of OIA tests The solid curves represent the 95% confidence region around the summary estimate; the dashed curves represent the 95% prediction region.
7
7
Summary ROC plot of RADT sensitivity and specificity for GAS detection: direct comparison of EIA versus OIA (n = 2). Each individual study cohort is represented by an empty black circle (EIA) and an empty red diamond (OIA), connected by a dotted line.
1
1. Test
All studies (n = 116).
2
2. Test
Complete verification (n = 105).
3
3. Test
EIA (direct comparison).
4
4. Test
OIA (direct comparison).
5
5. Test
Acceava Strep A (Biostar).
6
6. Test
ACON Strep A Rapid Test Strip.
7
7. Test
BioNexia Strep A (BioMerieux).
8
8. Test
CARDS QS Strep A (Quidel).
9
9. Test
Clearview Exact Strep A.
10
10. Test
Clearview Strep A.
11
11. Test
Diaquick Strep A Test (Dialab).
12
12. Test
Directgen 1‐2‐3 Group A Strep (Becton Dickinson).
13
13. Test
Direct Strep A EIA.
14
14. Test
EIA (no name).
15
15. Test
Group A Strep Test (Quidel).
16
16. Test
IM Strep A (International Microbio).
17
17. Test
Meridian Bioscience.
18
18. Test
OSOM Strep A (Genzyme).
19
19. Test
OSOM Ultra Strep A (Genzyme).
20
20. Test
QuickVue Dipstick Strep A (Quidel).
21
21. Test
QuickVue Flex Strep A (Quidel).
22
22. Test
QuickVue In‐Line Strep A (Quidel).
23
23. Test
QuickVue+ Strep A (Quidel).
24
24. Test
Sacks Biological Farms.
25
25. Test
SD Bioline Strep A.
26
26. Test
Signify Strep A (Abbott).
27
27. Test
SMART Group A Strep (New Horizons).
28
28. Test
Strep A Abon kit.
29
29. Test
Strep A OIA (Biostar).
30
30. Test
Strep A OIA Max (Biostar).
31
31. Test
Strep A Rapid Test Device.
32
32. Test
Strep A Sign.
33
33. Test
Strep A test II (INTEX Diagnostica).
34
34. Test
StreptAtest (Dectrapharm).
35
35. Test
Streptavit.
36
36. Test
Streptop A (ALL‐Diag).
37
37. Test
SUDS Group A Strep.
38
38. Test
SureScreen Test Strep A.
39
39. Test
TestPack Strep A (Abbott).
40
40. Test
TestPack Plus (Abbott).
41
41. Test
TestPack Plus Strep A with OBC II (Abbott).
42
42. Test
Ventrescreen Strep A (Ventrex Lab).
43
43. Test
Visuwell Strep A (ADI).
44
44. Test
Icon Strep A.
45
45. Test
Qtest (Becton Dickinson).
46
46. Test
Link 2 Strep A Rapid Test (Becton Dickinson).
47
47. Test
Event Test Strip Strep A.

Update of

  • Cochrane Database Syst Rev. doi: 10.1002/14651858.CD010502

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