One Step hCG Pregnancy Test (Cassette)
PRINCIPLE OF TEST
TESTING STEPS
Allow the test and the specimen to equilibrate to room temperature (15-30°C) prior to testing
1.To begin testing, open the sealed pouch by tearing along the notch. Remove the test kit from the pouch and use it as soon as possible.
2.Draw the urine sample using the pipette provided, and dispense 3-4 drops (200 µL) onto the sample well of the cassette (see diagram).
3.Wait for the pink colored bands to appear. Depending on the concentration of hCG. For all results, wait 5 to 10 minutes to confirm the observation. Do not interpret the result after 30 minutes. It is important that the background is clear before the result is read.
None of the substances at concentration tested interfered with the assay.
INTERFERING SUBSTANCES
The following substances were added in hCG free and 20 mIU/mL spiked samples.
Hemoglobin | 10 mg/mL |
bilirubin | 0.06 mg/mL |
albumin | 100 mg/mL |
None of the substances at concentration tested interfered with the assay.
COMPARISON STUDY
Other commercially available qualitative test kits were used to compare with One Step hCG Pregnancy Test for relative sensitivity and specificity in 201 urine samples. None of samples was discordant, the agreement is 100%.
Test |
Predicate Device |
Subtotal |
||
+ |
- |
|||
AIBO |
+ |
116 |
0 |
116 |
- |
0 |
85 |
85 |
|
Subtotal |
116 |
85 |
201 |
Sensitivity: 100%; Specificity: 100%