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Table 5 – Tested Substances for Interference
No interference detected
For swab samples
Aciclovir cream (2 %) 50 mg/g
Clotrimazol cream (1 %)
FEMSOFT powder (0.1 %)
KY Jelly (2 %)
Multi-Gyn IntiSkin (2 %)
Vagisan washing lotion (2 %)
Whole blood (2 %)
Xylocain gel (2 %)
Possibly interfering substance
Clotrimazol cream (2 %) (swab samples)
Table 6 – Diagnostic Sensitivity (PPA) and Specificity (NPA)
Swab samples
M. genitalium – swab
97.8 % (PPA; n = 45)
98.2 % (NPA; n = 55)
M. hominis – swab
90.0 % (PPA; n = 40)
100 % (NPA; n = 60)
U. parvum/ U. urealyticum – swab
96.1 % (PPA; n = 51)
95.9 % (NPA; n = 49)
Clinical performance data of Vivalytic MG, MH, UP/UU in comparison to the
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reference test system Allplex™ STI Essential Assay (Seegene). Retrospective
clinical study with in total 239 samples tested at one study site (132 urine and 107
swab specimens). In case of an insufficient number of either positive swabs or urine
specimens, samples were spiked with the respective target (inactivated bacterial
cells) in a concentration of approximately 2 – 3 × LoD.
Swab samples originated from vaginal, cervical, urethral, or rectal swab samples.
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Table 7 – Document History
Revision 01
Revision 02
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Initial document
Translation in 22 European languages
Vivalytic MG, MH, UP/UU
For urine samples
Acidity (pH 4.0)
Albumin (direct) 3 mg/ml
Alkalinity (pH 9.0)
Antibiotics (Amikacin) 30 µg/ml
Antibiotics (Gentamycin) 30 µg/ml
Bilirubin 0.2 mg/ml
Glucose 10 mg/ml
Urine Samples
M. genitalium – urine
97.7 % (PPA; n=44)
100 % (NPA; n=85)
M. hominis – urine
100 % (PPA; n=44)
98.8 % (NPA; n=85
U. parvum/ U. urealyticum – urine
90.2 % (PPA; n=51)
97.4 % (NPA; n=78)
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– Annex
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