One Step HCG Pregnancy Test (Midstream)
PRINCIPLE OF TEST
TESTING SEPS
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.Hold the handle of the test with one hand. Use the other hand to remove the cap and expose the absorbent. Put the cap aside for now.
3.Point the absorbent tip downward; place the absorbent tip in urine stream for at least 3 seconds to be thoroughly wet. Otherwise, you can collect your urine into a clean cup and dip half of the absorbent pad into the urine for at least 3 seconds.
4.Re-cap the device and wait for colored bands to appear. Depending on the concentration of hCG in the test specimen. 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.
opening the pouch, and stable for at least 100 days at transport conditions. The test kit should be kept away from direct sunlight, moisture and heat. The expiration dating was established under these storage conditions.
CROSS REACTIVITY
The following substances were added in hCG free and 20 mIU/mL spiked samples.
luteinizing hormone (LH) |
500mIU/ml |
follicle stimulating hormone (FSH) |
1000mIU/ml |
thyroid stimulating hormone(TSH) |
1000µIU/ml |
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%