Actim Partus 1ngeni Notice D'utilisation page 6

twenty days with two runs per day and two replicates per run (80 replicates per
sample). Sample concentrations and results are shown in Table 6.
Reproducibility
A Reproducibility study was performed. Six panels of specimens were tested
on five days with one run per day and five replicates per run using three
instruments (75 replicates per sample). The repeatability, within-laboratory and
reproducibility precision coefficients of variation, CV% are shown in Table 7.
Interference substances
The following substances were tested with the Actim Partus 1ngeni test and
were found not to affect the performance of the test.
INTERFERING SUBSTANCE
Surgical lubricant
Betadine
Econazole cream
Hexachlorophene cream
Progesterone capsule
Ultrasound transmission gel
Personal Lubricant
Baby powder
Baby oil
Feminine Deodorant Film
Vaginal Gel
Shower and bath products (various)
Bilirubin
• Pregnancy urine was tested with the Actim Partus 1ngeni test. No
interference of pregnancy urine was observed with the performance of the
test.
• Amniotic fluid was tested with the test. It was observed, that amniotic fluid
interferes with the performance of the test.
• Whole blood was tested with the test. It was observed, that whole blood
interferes with the performance of the test.
6
EN
CONCENTRATION TESTED
50%
50%
250 mg/mL
250 mg/mL
250 mg/mL
10%
10%
50%
50%
50%
10%
1%
500 µg/mL