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

OBJECTIVE

To compare the diagnostic performance of three rapid antigen detection tests (RADTs) for group A (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 ofKorea 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.