Actim PROM 1ngeni Gebrauchsanweisung Seite 6

Reproducibility
Reproducibility was assessed using samples containing 0 – 50 µg/l of IGFBP-1.
Two operators performed the testing on different days. Three lots of the test
were used; each lot read on a different instrument using the two test modes.
The specimens were tested using ten replicates for a total of 120 tests per
concentration. Negative samples were all identified negative and positive
samples were all identified positive. One hundred percent (100 %) agreement
with expected test results was obtained.
Method comparison
Performance of Actim PROM 1ngeni was compared to Actim PROM using spiked
vaginal samples containing different concentration levels of IGFBP-1. The
testing was performed by five operators using five different instruments. Overall
agreement between the test formats was 100 %. These results confirm that the
performance of Actim PROM 1ngeni test is similar to Actim PROM test (Table).
TABLE: METHOD COMPARISON BETWEEN ACTIM PROM 1NGENI
AND ACTIM PROM
Actim PROM POS
Actim PROM 1ngeni POS
Actim PROM 1ngeni NEG
Total
Diagnostic performance
Actim PROM test has been evaluated in several clinical studies. Selection of
typical studies is shown in FIG 1 on the inner back cover.
6
EN
Actim PROM NEG
50 0
0 50
50 50
Interfering substances
Whole blood, semen, urine, pH, several drugs, shower and bath products, odor
control products, and vaginal pathogens were tested with Actim PROM test and
were found not to affect Actim PROM test performance.
INTERFERING SUBSTANCE
Whole blood
Semen
Urine
pH
Pevaryl (active ingredient: econatzol.nitras)
Gyno-Trosyd (tioconazol)
Flagyl (metronidazole)
Canesten (clotrimazol)
Total Personal Lubricant
Baby Oil
50
Baby Powder
50
Feminine Deodorant Suppositories
100 Vaginal Gel
Candida albicans
Gardnerella vaginalis
Neisseria gonorrhea
Chlamydia trachomatis
HSV-1
HSV-2
Shower and bath products
INTERFERENCE
(NO/YES)
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No