Description

Pregnancy Test Cassette

One Step HCG Test Cassette is an in vitro diagnostic home use test device intended for the rapid determination of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy .

It is intended for over-the-counter (OTC) use. For in vitro diagnostic home use only.

Product Name	HCG Pregnancy Test cassette
Brand Name	CIBIO ® or OEM
Methodology	Colloidal Gold
Kits content	1. Test cassette
	2. Desiccant
	3. Instruction for use
Assay Type	Qualitative Detection
Specimen	Urine
Cut-off Level	10, 20 or 25 mIU/ml
Cassette Size	4.0mm
Certificates	CE 0123, ISO 13485, FDA 510K, MHRA, CFS/ FSC
Accuracy	Over 99%
Storage Temperature	4-30 degree centigrade
Shelf Life	36 Months
Delivery time	15-30 days
OEM Services	Logo, pouch, box, insert, private label
Loading Port	Guangzhou, Shenzhen

How to do the test?

1.Remove a Testing Device from the foil pouch by tearing at the notch and place it on a level surface.

2.Holding a sample dropper vertically, add 3 drops of the urine specimen to the sample well (with an arrow marked).

3.Read the result in five minutes. Positive results may sometimes appear as early as one minute but you should wait the full 5 minutes before determining a negative result.

Do not read results after more than 5 minutes.

How to read the results?

Negative (not pregnant) :

Only one color band appears, in the Control Zone. No apparent band on the Test Zone. This indicates that no pregnancy has been detected.

Positive (pregnant) :

Distinct color bands appear in the Control and Test Zones. It indicates that you are pregnant.

Invalid:

No visible band at all, or there is a visible band only in the test region and not in the control region. Repeat with a new test kit.

Q&A

Qus: There is much difference between the control lines of two tests. Is this a concern?

No. Variations in the color of the control band will not affect the test result.

Qus: Can test results be interpreted after more than five minutes?

No. Test results must be read in 5 minutes. A negative result may change to a false positive within minutes after the end of the testing period, which would not be an accurate reading. It is always best to read the results at the 5 minute testing period and then discard the test to avoid confusion.

Qus: How soon should I use the pregnancy test after tearing pouch?

The results of the package opened stability studies show that the products quality was stable and valid within 1.5 hours. Given variations in temperature and humidity that may occur , we suggest to use the test immediately after opening.