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In vitro evaluation of five rapid antigen detection tests for group A beta-haemolytic streptococcal sore throat infections

In vitro evaluation of five rapid antigen detection tests for group A beta-haemolytic streptococcal sore throat infections
In vitro evaluation of five rapid antigen detection tests for group A beta-haemolytic streptococcal sore throat infections
Background. Using accurate and easy to use rapid antigen detection tests (RADTs) to identify group A beta-haemolytic Streptococci (GABHS) sore throat infections could reduce unnecessary antibiotic prescribing and antimicrobial resistance. Although there is no international consensus on the use of RADTs, these kits have been widely adopted in Finland, France and the USA. Yet in the UK, the Clinical Knowledge Summaries, that provide the main online guidance for GPs, discourage RADTs use, citing their poor sensitivity and inability to impact on prescribing decisions in acute sore throat infections.

Objective. The purpose of this study was to evaluate the ease of use and in vitro accuracy (sensitivity and specificity) of the five most commonly used RADTs in Europe (OSOM Ultra, Quickvue Dipstick, Streptatest, Clearview Exact Strep A and IMI Test Pack).

Methods. To ensure the RADTs were evaluated objectively, a standardized in vitro method using known concentrations of GABHS was used to remove the inherent biases associated with clinical studies.

Results. The IMI Test Pack was the easiest RADT to use overall. The ability to detect all positive GABHS (sensitivity) varied considerably between kits from 95% [95% confidence interval (CI): 88–98%], for the IMI Test Pack and OSOM, to 62% (95% CI: 51–72%) for Clearview, at the highest GABHS concentration. None of the RADTs gave any false-positive results with commensal flora—they were 100% specific.

Conclusions. The IMI Test Pack is most suitable for use in primary care, as it had high sensitivity, high specificity and was easy to use.

diagnostic tests, drug resistance, infectious diseases, microbiology, public health
0263-2136
437-444
Lasseter, G.
96deede8-a2f0-47cf-95cd-da48a7ca9844
McNulty, C.
c38d50cd-cf07-4482-88c8-75e33e205295
Hobbs, F.
cae92948-95fc-414a-84f3-93149f941047
Mant, D.
10e94981-cd2c-4e56-8a11-54d9fc107117
Little, P.
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Barnett, J.
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Delaney, B.
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Glasziou, P.
c0469d98-7e80-450d-b354-e4bf74b209e4
Hanson, J.
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Hatwin, P.
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Kelly, J.
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Leydon, G.
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McManus, R.
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Moore, M.
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Mullee, M.
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Raftery, J.
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Salter, R.
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Smith, S.
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Thomas, T.
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Tuck, A.
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Williamson, I.
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Wright, L.
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PRISM Investigators
Lasseter, G.
96deede8-a2f0-47cf-95cd-da48a7ca9844
McNulty, C.
c38d50cd-cf07-4482-88c8-75e33e205295
Hobbs, F.
cae92948-95fc-414a-84f3-93149f941047
Mant, D.
10e94981-cd2c-4e56-8a11-54d9fc107117
Little, P.
1bf2d1f7-200c-47a5-ab16-fe5a8756a777
Barnett, J.
f10c0f99-e2f8-42e6-b52a-4987568453db
Delaney, B.
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Glasziou, P.
c0469d98-7e80-450d-b354-e4bf74b209e4
Hanson, J.
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Hatwin, P.
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Kelly, J.
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Leydon, G.
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McManus, R.
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Moore, M.
ecbb2f74-c944-46ec-8029-45356a908bba
Mullee, M.
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Raftery, J.
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Salter, R.
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Smith, S.
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Thomas, T.
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Tuck, A.
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Williamson, I.
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Wright, L.
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Lasseter, G., McNulty, C. and Hobbs, F. et al. , PRISM Investigators (2009) In vitro evaluation of five rapid antigen detection tests for group A beta-haemolytic streptococcal sore throat infections. Family Practice, 26 (6), 437-444. (doi:10.1093/fampra/cmp054). (PMID:19748913)

Record type: Article

Abstract

Background. Using accurate and easy to use rapid antigen detection tests (RADTs) to identify group A beta-haemolytic Streptococci (GABHS) sore throat infections could reduce unnecessary antibiotic prescribing and antimicrobial resistance. Although there is no international consensus on the use of RADTs, these kits have been widely adopted in Finland, France and the USA. Yet in the UK, the Clinical Knowledge Summaries, that provide the main online guidance for GPs, discourage RADTs use, citing their poor sensitivity and inability to impact on prescribing decisions in acute sore throat infections.

Objective. The purpose of this study was to evaluate the ease of use and in vitro accuracy (sensitivity and specificity) of the five most commonly used RADTs in Europe (OSOM Ultra, Quickvue Dipstick, Streptatest, Clearview Exact Strep A and IMI Test Pack).

Methods. To ensure the RADTs were evaluated objectively, a standardized in vitro method using known concentrations of GABHS was used to remove the inherent biases associated with clinical studies.

Results. The IMI Test Pack was the easiest RADT to use overall. The ability to detect all positive GABHS (sensitivity) varied considerably between kits from 95% [95% confidence interval (CI): 88–98%], for the IMI Test Pack and OSOM, to 62% (95% CI: 51–72%) for Clearview, at the highest GABHS concentration. None of the RADTs gave any false-positive results with commensal flora—they were 100% specific.

Conclusions. The IMI Test Pack is most suitable for use in primary care, as it had high sensitivity, high specificity and was easy to use.

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More information

e-pub ahead of print date: 11 September 2009
Published date: December 2009
Additional Information: Dr Geraldine Leydon was one of the PRISM Investigators
Keywords: diagnostic tests, drug resistance, infectious diseases, microbiology, public health

Identifiers

Local EPrints ID: 73450
URI: http://eprints.soton.ac.uk/id/eprint/73450
ISSN: 0263-2136
PURE UUID: 52d03bc6-0376-4c57-b93d-e5f3049ad736
ORCID for P. Little: ORCID iD orcid.org/0000-0003-3664-1873
ORCID for G. Leydon: ORCID iD orcid.org/0000-0001-5986-3300

Catalogue record

Date deposited: 05 Mar 2010
Last modified: 11 Jul 2024 01:43

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Contributors

Author: G. Lasseter
Author: C. McNulty
Author: F. Hobbs
Author: D. Mant
Author: P. Little ORCID iD
Author: J. Barnett
Author: B. Delaney
Author: P. Glasziou
Author: J. Hanson
Author: P. Hatwin
Author: J. Kelly
Author: G. Leydon ORCID iD
Author: R. McManus
Author: M. Moore
Author: M. Mullee
Author: J. Raftery
Author: R. Salter
Author: S. Smith
Author: T. Thomas
Author: A. Tuck
Author: I. Williamson
Author: L. Wright
Corporate Author: PRISM Investigators

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