Semi-quantitative hCG One-step Pregnancy Test

（5 in 1 dipcard）

For Self-testing and In Vitro diagnostic use only

INTENDED USE

Semi-quantitative hCG One-step Pregnancy Test（5 in 1 dipcard） is a self-performing immunoassay designed for the qualitative determination of human chorionic gonadotropin (HCG) in urine for early detection of pregnancy. The test device is intended for self-testing.

PRINCIPLE

Semi-quantitative hCG One-step Pregnancy Test（5 in 1 dipcard） is intended used for determine the human Chorionic Gonadotrophin (hCG) level in the women urine.

When there are two lines (C and T lines) can be found on the test, it proves that sample contains detection objective, the result is positive. However, if sample doesn’t contain detection objective, immune complex can’t be formed on the testing line (T line), only appear one color belt on C line, the result is negative.

One dipcard consists of five HCG strips with different minimum detectable concentration.: Strip I/25mIU/ml, Strip II/100mIU/ml, Strip III /600mIU/ml, Strip IV/2000mIU/ml, Strip V/10000mIU/ml, these five HCG strips are assembled in one dipcard. When dip the absorbent tips into the urine samples, according to the positive or negative results showed on the strips, HCG level in the urine can be semi-determined.

MATERIALS PROVIDED

Each pouch contains:

1. One Semi-quantitative hCG One-step Pregnancy Test（5 in 1 dipcard）

2. Desiccant

Each box contains

One Semi-quantitative hCG One-step Pregnancy Test（5 in 1 dipcard）foil pouch1. 

2. Package insert

Materials required but not provided

1. Timer

2. Specimen collection container

STORAGE AND STABILITY:

Store test strip at 4~ 30°C (room temperature). Avoid sunlight. The test is stable until the date imprinted on the pouch label.

ASSAY PROCEDURE

1. DETERMINATION OF TEST DATE 

The test could be used from the first missing date of period.

2.SPECIMEN COLLECTION AND HANDLING

The Semi-quantitative hCG One-step Pregnancy Test（5 in 1 dipcard） is formulated for use with fresh urine specimens. The test should be used right after the specimen collection. Urine cup should be used to collect specimens, and the urine does not require any special pretreatment.

3. TEST PROCEDURE

1. Remove the test dipcard from the foil pouch, and remove the cap from the dipcard..

2. Submerge the tip of the test device into the urine sample in a urine cup for 10-20 seconds. Remove the test dipcard from the urine, replace the cap and lay the test on a flat surface with the result window facing up.

3. Read the test result 1-5 minutes after the control lines. Result after 10 minutes is invalid.

DO NOT INTERPRET RESULT AFTER 10 MINUTES.

4. INTERPRETATION OF RESULTS

a) Invalid result: none of the strips-controlled zone show colored band in ten minutes.

b) Negative (-) result: Colored band shows in the C zone, but not in the T zone on single strip.

If all five strips show negative result we can get full negative result.

  c) Positive result includes following five situation:

  positive（+）：when the HCG concentration of the sample reaches 25mIU/mL～100 mIU/mL , All the five  strips show colored band in the C zone. Only strip I shows colored band in the T zone while others show no bands in this zone

  Positive (++): when the HCG concentration of the sample reaches 100mIU/mL～600 mIU/mL, all the five strips shows colored band in the C zone, Strip I and Strip II shows colored band in the T zone while other three strips show no bands in this zone

  Positive (+++): when the HCG concentration of the sample reaches 600mIU/mL～2000 mIU/mL , all the five strips show colored band in the C zone. Strip I, strip II and strip III shows colored band in the T zone, while strip IV and strip V show no bands in this zone

  Positive (++++): when the HCG concentration of the sample reaches 2000mIU/mL～10000mIU/mL, all the five strips show colored band in the C zone. Strip I, strip II, strip III, and strip IV show colored band in the T zone, while strip V shows no bands in this zone.

  Positive (+++++): when the HCG concentration reaches 10000mIU/mL, all five strips show colored band in the C zone and T zone.

Attention:  Minimum detectable HCG concentration: strip I /25 mIU/mL; strip II/100 mIU/mL; strip III/ 600 mIU/mL; strip IV/2000mIU/mL: strip V/10000 mIU/mL

 Normally, during the first eight weeks of pregnancy, HCG concentration in the morning urine should increase by the time. If the HCG concentration does not increase or even decrease, please seek medical advice

Table 1. Comparison table of HCG concentrations between natural gestational weeks and gestational weeks.

Remarks: Gestational weeks are counted from the date of implantation of the fertilized egg; Natural gestational weeks are counted from the first day of the last menstrual period.

Normal pregnancy concentration changes are: during 0-4.5 weeks of pregnancy (gestational weeks), the concentration of HCG in urine doubles every 1.4-2.2 days; 4.5-5 weeks of pregnancy (gestational weeks), the concentration of HCG in urine doubles every 3.3-3.5 days times; HCG concentration is peaked at 6-8 weeks (gestational week), and then decreased slightly to maintain a certain concentration level. Pregnancy is suspected but positive results cannot be detected using this product or the HCG concentration value has not changed as mentioned above, or the HCG concentration test does not reach 2000mIU/mL (++++) when the gestational week reaches 4-5 weeks and above, which may be abnormal pregnant such as ectopic pregnancy and should seek medical advice.

• Pregnant for 0-4.5 weeks (gestational week)，the hCG concentration in urine

doubles every 1.4-2.2days, thus is suggested to test every 2 days.

• Pregnant for over 4.5-5 weeks (gestational week), the hCG concentration in urine doubles every 3.3-3.5 days, thus is suggested to test every 3 days; If the tested hCG concentration is over 10000 mIU/ml, then needs to dilute 5-10 times and test again. The tested value multiplies the diluent times is the real concentration value in the urine.

Note：

• Dilute 5 times means 1 urine sample mixed with 4 times of the same amount water.

• Dilute 10 times means 1 urine sample mixed with 9 times of the same amount water

QUALITY CONTROL

Built in Quality Control Features

After addition of the sample these colored bands migrate along the membrane at the leading edge of the dye conjugate and are “removed” from the test device completely.

When the test is complete, you will see a pink-purple colored band in the “C” area of the test strip on negative samples and a pink-purple colored band in the “T” and “C” area on positive samples. The appearance of the CONTROL band indicates that the test strip is performing properly and serves as a procedural control.