Performance evaluation of three rapid antigen tests for the diagnosis of group A Streptococci

Ha Nui Kim, Jeeyong Kim, Woong Sik Jang, Jeonghun Nam, Chae Seung Lim

Research output: Contribution to journalArticle

Abstract

Objective: To compare the diagnostic performance of three rapid antigen detection tests (RADTs) for group A Streptococcus (GAS). Design: A hospital-based, cross-sectional, retrospective study. Setting: A comparative study of rapid diagnostic tests for GAS using clinical specimens in a single institute. Participants: 225 children in the outpatient clinics of Korea University Guro Hospitalwith suspicious symptoms were subjected to throat swab sampling. A dual-swab applicator was used. Samples were stored at below -70°C in a 10 mL transport tube containing 1 mL liquid Stuart's transport medium. Outcome measures: All tests were performed in the laboratory by trained clinical laboratory scientists. Sensitivity, specificity, accuracy and kappa index of three RADTs were compared with the reference PCR test and culture results. Results: Of the 225 patients suspected of having GAS, 67 and 90 were positive for GAS in the culture and PCR tests, respectively. Compared with the reference culture, the sensitivity for GAS was 92.5% (CI 83.4 to 97.5), 71.6% (CI 59.3 to 81.9) and 74.63% (CI 62.5 to 84.4) for careUS Strep A Plus, SD Bioline and BD Veritor, respectively, and the specificity was 97.0% (CI 93.1 to 99.0), 94.6% (CI 90.1 to 97.5) and 92.9% (CI 87.8 to 96.2) for careUS Strep A Plus, SD Bioline and BD Veritor, respectively. Compared with the reference GAS real-time PCR, the sensitivity was 73.3% (CI 62.9 to 82.1), 63.3% (CI 52.5 to 73.2) and 67.8% (CI 57.1 to 77.2) for careUS Strep A Plus, SD Bioline and BD Veritor, respectively, and the specificity was 99.3% (CI 95.9 to 99.9), 100.0% (CI 97.3 to 100.0) and 99.3% (CI 95.9 to 99.9) for careUS Strep A Plus, SD Bioline and BD Veritor, respectively. Conclusions: The careUS Strep A Plus is a useful test that showed highly comparable results with those of the culture test and superior performances among the three RADTs. The use of RADTs should be encouraged to provide acceptable and fast results using simple equipment.

Original languageEnglish
Article numbere025438
JournalBMJ open
Volume9
Issue number8
DOIs
Publication statusPublished - 2019 Aug 1

Fingerprint

Streptococcus
Antigens
Medical Laboratory Personnel
Hospital Design and Construction
Polymerase Chain Reaction
Korea
Pharynx
Ambulatory Care Facilities
Routine Diagnostic Tests
Real-Time Polymerase Chain Reaction
Retrospective Studies
Cross-Sectional Studies
Outcome Assessment (Health Care)
Sensitivity and Specificity
Equipment and Supplies

Keywords

  • group A streptococcus
  • pharyngitis
  • rapid antigen detection test

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Performance evaluation of three rapid antigen tests for the diagnosis of group A Streptococci. / Kim, Ha Nui; Kim, Jeeyong; Jang, Woong Sik; Nam, Jeonghun; Lim, Chae Seung.

In: BMJ open, Vol. 9, No. 8, e025438, 01.08.2019.

Research output: Contribution to journalArticle

Kim, Ha Nui ; Kim, Jeeyong ; Jang, Woong Sik ; Nam, Jeonghun ; Lim, Chae Seung. / Performance evaluation of three rapid antigen tests for the diagnosis of group A Streptococci. In: BMJ open. 2019 ; Vol. 9, No. 8.
@article{dd8c17d9db3b48a49e53d90de36602fe,
title = "Performance evaluation of three rapid antigen tests for the diagnosis of group A Streptococci",
abstract = "Objective: To compare the diagnostic performance of three rapid antigen detection tests (RADTs) for group A Streptococcus (GAS). Design: A hospital-based, cross-sectional, retrospective study. Setting: A comparative study of rapid diagnostic tests for GAS using clinical specimens in a single institute. Participants: 225 children in the outpatient clinics of Korea University Guro Hospitalwith suspicious symptoms were subjected to throat swab sampling. A dual-swab applicator was used. Samples were stored at below -70°C in a 10 mL transport tube containing 1 mL liquid Stuart's transport medium. Outcome measures: All tests were performed in the laboratory by trained clinical laboratory scientists. Sensitivity, specificity, accuracy and kappa index of three RADTs were compared with the reference PCR test and culture results. Results: Of the 225 patients suspected of having GAS, 67 and 90 were positive for GAS in the culture and PCR tests, respectively. Compared with the reference culture, the sensitivity for GAS was 92.5{\%} (CI 83.4 to 97.5), 71.6{\%} (CI 59.3 to 81.9) and 74.63{\%} (CI 62.5 to 84.4) for careUS Strep A Plus, SD Bioline and BD Veritor, respectively, and the specificity was 97.0{\%} (CI 93.1 to 99.0), 94.6{\%} (CI 90.1 to 97.5) and 92.9{\%} (CI 87.8 to 96.2) for careUS Strep A Plus, SD Bioline and BD Veritor, respectively. Compared with the reference GAS real-time PCR, the sensitivity was 73.3{\%} (CI 62.9 to 82.1), 63.3{\%} (CI 52.5 to 73.2) and 67.8{\%} (CI 57.1 to 77.2) for careUS Strep A Plus, SD Bioline and BD Veritor, respectively, and the specificity was 99.3{\%} (CI 95.9 to 99.9), 100.0{\%} (CI 97.3 to 100.0) and 99.3{\%} (CI 95.9 to 99.9) for careUS Strep A Plus, SD Bioline and BD Veritor, respectively. Conclusions: The careUS Strep A Plus is a useful test that showed highly comparable results with those of the culture test and superior performances among the three RADTs. The use of RADTs should be encouraged to provide acceptable and fast results using simple equipment.",
keywords = "group A streptococcus, pharyngitis, rapid antigen detection test",
author = "Kim, {Ha Nui} and Jeeyong Kim and Jang, {Woong Sik} and Jeonghun Nam and Lim, {Chae Seung}",
year = "2019",
month = "8",
day = "1",
doi = "10.1136/bmjopen-2018-025438",
language = "English",
volume = "9",
journal = "BMJ Open",
issn = "2044-6055",
publisher = "BMJ Publishing Group",
number = "8",

}

TY - JOUR

T1 - Performance evaluation of three rapid antigen tests for the diagnosis of group A Streptococci

AU - Kim, Ha Nui

AU - Kim, Jeeyong

AU - Jang, Woong Sik

AU - Nam, Jeonghun

AU - Lim, Chae Seung

PY - 2019/8/1

Y1 - 2019/8/1

N2 - Objective: To compare the diagnostic performance of three rapid antigen detection tests (RADTs) for group A Streptococcus (GAS). Design: A hospital-based, cross-sectional, retrospective study. Setting: A comparative study of rapid diagnostic tests for GAS using clinical specimens in a single institute. Participants: 225 children in the outpatient clinics of Korea University Guro Hospitalwith suspicious symptoms were subjected to throat swab sampling. A dual-swab applicator was used. Samples were stored at below -70°C in a 10 mL transport tube containing 1 mL liquid Stuart's transport medium. Outcome measures: All tests were performed in the laboratory by trained clinical laboratory scientists. Sensitivity, specificity, accuracy and kappa index of three RADTs were compared with the reference PCR test and culture results. Results: Of the 225 patients suspected of having GAS, 67 and 90 were positive for GAS in the culture and PCR tests, respectively. Compared with the reference culture, the sensitivity for GAS was 92.5% (CI 83.4 to 97.5), 71.6% (CI 59.3 to 81.9) and 74.63% (CI 62.5 to 84.4) for careUS Strep A Plus, SD Bioline and BD Veritor, respectively, and the specificity was 97.0% (CI 93.1 to 99.0), 94.6% (CI 90.1 to 97.5) and 92.9% (CI 87.8 to 96.2) for careUS Strep A Plus, SD Bioline and BD Veritor, respectively. Compared with the reference GAS real-time PCR, the sensitivity was 73.3% (CI 62.9 to 82.1), 63.3% (CI 52.5 to 73.2) and 67.8% (CI 57.1 to 77.2) for careUS Strep A Plus, SD Bioline and BD Veritor, respectively, and the specificity was 99.3% (CI 95.9 to 99.9), 100.0% (CI 97.3 to 100.0) and 99.3% (CI 95.9 to 99.9) for careUS Strep A Plus, SD Bioline and BD Veritor, respectively. Conclusions: The careUS Strep A Plus is a useful test that showed highly comparable results with those of the culture test and superior performances among the three RADTs. The use of RADTs should be encouraged to provide acceptable and fast results using simple equipment.

AB - Objective: To compare the diagnostic performance of three rapid antigen detection tests (RADTs) for group A Streptococcus (GAS). Design: A hospital-based, cross-sectional, retrospective study. Setting: A comparative study of rapid diagnostic tests for GAS using clinical specimens in a single institute. Participants: 225 children in the outpatient clinics of Korea University Guro Hospitalwith suspicious symptoms were subjected to throat swab sampling. A dual-swab applicator was used. Samples were stored at below -70°C in a 10 mL transport tube containing 1 mL liquid Stuart's transport medium. Outcome measures: All tests were performed in the laboratory by trained clinical laboratory scientists. Sensitivity, specificity, accuracy and kappa index of three RADTs were compared with the reference PCR test and culture results. Results: Of the 225 patients suspected of having GAS, 67 and 90 were positive for GAS in the culture and PCR tests, respectively. Compared with the reference culture, the sensitivity for GAS was 92.5% (CI 83.4 to 97.5), 71.6% (CI 59.3 to 81.9) and 74.63% (CI 62.5 to 84.4) for careUS Strep A Plus, SD Bioline and BD Veritor, respectively, and the specificity was 97.0% (CI 93.1 to 99.0), 94.6% (CI 90.1 to 97.5) and 92.9% (CI 87.8 to 96.2) for careUS Strep A Plus, SD Bioline and BD Veritor, respectively. Compared with the reference GAS real-time PCR, the sensitivity was 73.3% (CI 62.9 to 82.1), 63.3% (CI 52.5 to 73.2) and 67.8% (CI 57.1 to 77.2) for careUS Strep A Plus, SD Bioline and BD Veritor, respectively, and the specificity was 99.3% (CI 95.9 to 99.9), 100.0% (CI 97.3 to 100.0) and 99.3% (CI 95.9 to 99.9) for careUS Strep A Plus, SD Bioline and BD Veritor, respectively. Conclusions: The careUS Strep A Plus is a useful test that showed highly comparable results with those of the culture test and superior performances among the three RADTs. The use of RADTs should be encouraged to provide acceptable and fast results using simple equipment.

KW - group A streptococcus

KW - pharyngitis

KW - rapid antigen detection test

UR - http://www.scopus.com/inward/record.url?scp=85070393309&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85070393309&partnerID=8YFLogxK

U2 - 10.1136/bmjopen-2018-025438

DO - 10.1136/bmjopen-2018-025438

M3 - Article

C2 - 31383693

AN - SCOPUS:85070393309

VL - 9

JO - BMJ Open

JF - BMJ Open

SN - 2044-6055

IS - 8

M1 - e025438

ER -