Product Manual

Page 8 of 64QuickVue Dipstick Strep A test
FOR INFORMATIONAL USE ONLY

FOR INFORMATIONAL USE ONLY
Not to be used for performing assay. Refer to most current package insert accompanying your test kit.
performance characterIstIcs
Field Study
In a multi-center field evaluation, a total of 329 throat swab specimens were collected
from patients presenting with pharyngitis. Each swab was inoculated onto a sheep
blood agar plate, then tested by the QuickVue Dipstick Strep A test. Plates were
incubated for 24–48 hours at 37°C with a Bacitracin disk. Presumptive GAS colonies
were confirmed with commercially available Strep A testing kits.
Of the 329 total specimens, 192 were negative and 137 were positive by culture. The
QuickVue test identified 188 of the culture negative and 126 of the culture positive for a
specificity of 98% and a sensitivity of 92%. The 95% confidence intervals were calculated
to be 95%–99% for specificity and 86%–96% for sensitivity. Overall agreement between
culture and the QuickVue Dipstick Strep A test was 95%. These study results demonstrate
that no statistical differences were observed between the QuickVue test and standard
culture techniques.
In addition, the QuickVue test was used to confirm the identification of Group A Streptococcus
on blood agar plates. As a culture confirmation, the test was 100% sensitive.
Culture Classification QuickVue Results
Total Negative
Specificity
188/192 (98%)
1+ (≤ 10 colonies) 16/20 (80%)
Rare 1/3 (33%)
2+ (11–50 colonies) 46/49 (94%)
3+ (> 50 colonies) 28/30 (93%)
4+ (predominant growth) 35/35 (100%)
Total Positive
Sensitivity
126/137 (92%)
Total Agreement 314/329 (95%)
Sensitivity: 126/137 = 92%
Specificity: 188/192 = 98%
Agreement: 314/329 = 95%
Culture
+
Culture
–
Total
QuickVue –
QuickVue +
126 4
11
137
188
192