Medix Biochemica Actim PROM 1ngeni Notice D'utilisation page 6

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.
Actim PROM NEG Total
50 0 50
0 50 50
50 50 100
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)
Personal Lubricant
Baby Oil
Baby Powder
Feminine Deodorant Suppositories
Vaginal Gel
Candida albicans
Gardnerella vaginalis
Neisseria gonorrhea
Chlamydia trachomatis
HSV-1
HSV-2
Shower and bath products
6
EN
INTERFERENCE
(NO/YES)
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No