abf diagnostics GmbH
Gewerbepark 14
D-85402 Kranzberg
Germany
T.: +49/8166-9986-130
F.: +49/8166-9986-140
E.: [email address]
Kranzberg, 14th of March 2025
Evaluation Report - Securetec DrugWipe 3 S (S303G.91)
Introduction
DrugWipe 3 S test kits were evaluated for specificity and sensitivity in compliance around
nominated cut-offs for each of the three analyte groups in accordance to Appendix C3 auf AS/NZS
4760:2019 with the following protocol.
Methods:
Drug solutions were prepared by spiking pooled saliva of 10 volunteers with the analytes. The
final dilutions provide a test sample with a concentration 50 % above (high drug “spiked” solution)
or 50 % below (lower drug “spiked” solution) the specified cut-off.
s 9(2)(b)(ii) OIA, s 9(2)(k) OIA, s 9(2)(ba)(i) OIA
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s 9(2)(b)(ii) OIA, s 9(2)(ba)(i) OIA, s 9(2)(k) OIA
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Specificity testing:
10 µL of each lower drug “spiked” solution was pipetted onto the respective wiping fleece of the
DrugWipe® sample collectors and tests were performed according to the enclosed instructions
for use. The tests were evaluated visually as described in the instructions for use.
An appearing red control line and no red test line shows a negative result.
Sensitivity testing:
10 µL of each high drug “spiked” solution was pipetted onto the respective wiping fleece of the
DrugWipe® sample collectors and tests were performed according to the enclosed instructions
for use. The tests were evaluated visually as described in the instructions for use.
An appearing red control line and a red test line shows a positive result.
Results:
Specificity at – 50% cut-off
Analyte
Concentration
Negative results
% Correct results
Δ9-THC
7 ng/ml
27/30
90%
D-
25 ng/ml
27/30
90%
Methamphetamine/
D.L-MDMA
Cocaine
25 ng/ml
29/30
96%
Sensitivity at + 50% cut-off
Analyte
Concentration
Positive results
% Correct results
Δ9-THC
22 ng/ml
28/30
93%
D-
75 ng/ml
30/30
100%
Methamphetamine/
D.L-MDMA
Cocaine
75 ng/ml
29/30
96%
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Summary:
DrugWipe 3 S (S304G.91) test kits fulfil ed the criteria of Appendix C3 of AS/NZS 4760:2019 with
not more than a total of 10% false positive results in specificity testing at – 50% of the respective
cut-offs and not more than a total of 10% false negative results in sensitivity testing at + 50% of
the respective cut-offs for THC, Methamphetamine/MDMA and Cocaine.
Kranzberg, 14th of March 2025
……………………………….
Dr. Franz Aberl
abf diagnostics GmbH
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