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

Gemma M. Lasseter, Cliodna A M McNulty, F. D. Richard Hobbs, David Mant, Paul Little, PRISM Investigators

Research output: Contribution to journalArticleResearchpeer-review

22 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)437-444
Number of pages8
JournalFamily Practice
Volume26
Issue number6
DOIs
Publication statusPublished - 2009

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Pharyngitis
Antigens
Streptococcus
Infection
Confidence Intervals
Sensitivity and Specificity
Finland
In Vitro Techniques
France
Primary Health Care
Anti-Bacterial Agents

Cite this

Lasseter, G. M., McNulty, C. A. M., Richard Hobbs, F. D., Mant, D., Little, P., & 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. https://doi.org/10.1093/fampra/cmp054
Lasseter, Gemma M. ; McNulty, Cliodna A M ; Richard Hobbs, F. D. ; Mant, David ; Little, Paul ; PRISM Investigators. / In vitro evaluation of five rapid antigen detection tests for group A beta-haemolytic streptococcal sore throat infections. In: Family Practice. 2009 ; Vol. 26, No. 6. pp. 437-444.
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title = "In vitro evaluation of five rapid antigen detection tests for group A beta-haemolytic streptococcal sore throat infections",
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.",
author = "Lasseter, {Gemma M.} and McNulty, {Cliodna A M} and {Richard Hobbs}, {F. D.} and David Mant and Paul Little and Jane Barnett and Brendan Delaney and Paul Glasziou and Jessica Hanson and Peter Hawtin and Jo Kelly and Leydon, {Geraldine M.} and Richard McManus and Mike Moore and Mark Mullee and James Raftery and Ros Salter and Sue Smith and Tammy Thomas and Andy Tuck and Ian Williamson and Lucy Wright and {PRISM Investigators}",
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Lasseter, GM, McNulty, CAM, Richard Hobbs, FD, Mant, D, Little, P & PRISM Investigators 2009, 'In vitro evaluation of five rapid antigen detection tests for group A beta-haemolytic streptococcal sore throat infections' Family Practice, vol. 26, no. 6, pp. 437-444. https://doi.org/10.1093/fampra/cmp054

In vitro evaluation of five rapid antigen detection tests for group A beta-haemolytic streptococcal sore throat infections. / Lasseter, Gemma M.; McNulty, Cliodna A M; Richard Hobbs, F. D.; Mant, David; Little, Paul; PRISM Investigators.

In: Family Practice, Vol. 26, No. 6, 2009, p. 437-444.

Research output: Contribution to journalArticleResearchpeer-review

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T1 - In vitro evaluation of five rapid antigen detection tests for group A beta-haemolytic streptococcal sore throat infections

AU - Lasseter, Gemma M.

AU - McNulty, Cliodna A M

AU - Richard Hobbs, F. D.

AU - Mant, David

AU - Little, Paul

AU - Barnett, Jane

AU - Delaney, Brendan

AU - Glasziou, Paul

AU - Hanson, Jessica

AU - Hawtin, Peter

AU - Kelly, Jo

AU - Leydon, Geraldine M.

AU - McManus, Richard

AU - Moore, Mike

AU - Mullee, Mark

AU - Raftery, James

AU - Salter, Ros

AU - Smith, Sue

AU - Thomas, Tammy

AU - Tuck, Andy

AU - Williamson, Ian

AU - Wright, Lucy

AU - PRISM Investigators

PY - 2009

Y1 - 2009

N2 - 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.

AB - 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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