Klinisk Biokemi i Norden · 1 2019
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goals. The analytical quality goals were a diagnostic
sensitivity >80 % and a diagnostic specificity >95 %,
when compared to the results from the comparison
method. The quality goal for user-friendliness was a
total rating of “satisfactory”. The prevalence and posi-
tive and negative predictive values were calculated.
Results
The diagnostic sensitivity of DIAQUICK Strep A Blue
Dipstick was 72 % and the diagnostic specificity was
98 %, when compared to the results from the com-
parison method.
The prevalence of Strep A among the patients was
30 %, and the positive and negative predictive values
of the rapid test were 94 % and 89 %, respectively. The
user-friendliness was rated as satisfactory.
Conclusion
The quality goal set for diagnostic sensitivity was not
fulfilled. The quality goal for diagnostic specificity
was fulfilled. The quality goal for user-friendliness
was fulfilled.
The complete evaluation report is available at
www.
skup.org. A letter with comments from DIALAB
GmbH/Medic 24 is attached to the report.
Number of true positive results
Number of false negative results
Diagnostic sensitivity
76
29
72 %
Number of true negative results
Number of false positive results
Diagnostic specificity
238
5
98 %
The procedure of DIAQUICK Strep A Blue Dipstick
