Description

HCG Pregnancy Test Strip

One Step HCG Test Strip 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. You can easily carry out yourself. It is intended for over-the-counter (OTC) use. For in vitro diagnostic use only.

Product Name	HCG Pregnancy Test Strip
Brand Name	CIBIO ® or OEM
Methodology	Colloidal Gold
Kits content	1. Test strip
	2. Desiccant
	3. Instruction for use
Assay Type	Qualitative Detection
Specimen	Urine
Cut-off Level	10, 20 or 25 mIU/ml
Specification	2.5mm/3.0mm/3.5mm/4.0mm/5.0mm/6.0mm
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?

The test strip and urine have to be at room temperature 59-86ºF (15-30°C) for testing.
1. Remove the test strip from the sealed pouch.
2. Immerse the strip into the urine with the arrow pointing towards the urine.
3. Take the strip out after 5 seconds and lay the strip flat on a clean, dry, nonabsorbent surface (such as the mouth of the urine container).
IMPORTANT： Do not allow the urine level to exceed the MAX (marker line), otherwise the test will not perform correctly.
4. Read results 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.

NOTE: if the color in the Test Zone is weak, it is recommended that the test be repeated in 48 hours, or if the test shows negative but you suspect you may still be pregnant, the test may be repeated after a few days.

Q&A

Qus: 1. How do I use the HCG pregnancy test?

Collect a urine sample in a clean, dry container and follow the instructions for the specific test format. Collect the sample as directed and read the result within 5 mins.

Qus: When is the best time to take an HCG pregnancy test?

The test can generally be used from the expected period date. For early testing, using first-morning urine may help provide a more concentrated sample.

Qus: Can I use the test before my missed period?

Yes. Some high-sensitivity HCG tests are designed for early testing before a missed period. However, testing too early may produce a negative result even if pregnancy has occurred.

Qus: Can I use the test at any time of the day?

Yes, but first-morning urine is often recommended for early testing because it may contain a higher concentration of HCG

Qus: What does a positive HCG test result mean?

A positive result indicates that HCG has been detected in the urine. Pregnancy should be confirmed with a healthcare professional when appropriate.

Qus: What does a negative HCG test result mean?

A negative result means HCG was not detected at the test’s detection level. If pregnancy is still suspected or the period is delayed, repeat testing according to the instructions.

Qus: What should I do if the test shows an invalid result?

An invalid result usually means the test did not work correctly. Use a new test and carefully follow the instructions. Check that the control line appears as required.

Qus: Can I repeat the test if the result is negative but my period is still delayed?

Yes. If the result is negative but the period remains delayed, repeat the test after a few days or consult a healthcare professional for further evaluation.