Check4® Pregnancy Urine Test Strips

As the test sample flows through the absorbent strip, the labelled antibody-dye conjugate binds to the hCG, forming an antibody-antigen complex. This complex binds to the anti-hCG antibody and produces a red/pink coloured band in the positive reaction zone (see diagram) when the hCG concentration is greater than or equal to 25 mIU/mL. In the absence of hCG, there is no band in the positive reaction zone.

The reaction mixture continues flowing through the absorbent portion of the strip past the positive reaction zone and control zone. The hCG non-specific part of the conjugate binds to the reagents in the control zone, producing a red/pink coloured band, demonstrating that the reagents are functioning correctly.

Urine: For the optimal detection of pregnancy, a urine specimen collected first thing in the morning is preferable since it contains the highest concentration of hCG. However, urine specimens collected at any time may also be used.

1.Urine from healthy men and non-pregnant women will normally show undetectable levels of hCG when tested on Check4® Pregnancy test strips. Although the hCG levels in women during the early stages of pregnancy are variable and hCG levels may still be low, Check4® Pregnancy test strips are usually capable of detecting hCG levels to confirm pregnancy by the first day of the missed menstrual period.

2.In addition to pregnancy, hCG has been found in patients with both gestational and non-gestational trophoblastic disease. Since the hCG of trophoblastic neoplasms is similar to that found in pregnancy, these conditions, which include choriocarcinoma and hydatidiform mole, should be ruled out before a diagnosis of pregnancy is reached.

3.A normal pregnancy cannot be distinguished from an ectopic pregnancy based on hCG levels alone. Also, spontaneous miscarriage may cause confusion in interpreting test results.

4.A very early pregnancy containing an extremely low concentration of hCG can give a negative result. In this case, another specimen should be obtained at least 48 hours later and tested.

5.hCG levels may remain detectable for several weeks after normal delivery, delivery by caesarean section, spontaneous abortion, or therapeutic abortion.

6.Some serum specimens with high concentration of rheumatoid factor (RF), heterophiles or Forssman antibodies may yield non-specific positive results during testing. Such cases should be identified before testing.

7.As for any diagnostic procedure, the physician or clinician should evaluate data obtained by the use of this kit in light of other clinical information.

8.The presence of hydroxyethyl-cellulose in the composition of catheter lubricant may give false positive results with Check4® Pregnancy test strips at a concentration equal or higher than 0.1%.

1.This test is designed for in vitro diagnostic use and for healthcare professional use only.
2.Carefully read the instructions before carrying out the test.
3.Do not use after the expiry date printed on the package label.
4.If the product pot is damaged and not sealable then the Check4® Pregnancy test strips should not be used.
5.Wear protective clothing such as laboratory coats and disposable gloves while assaying samples.
6.Follow relevant local procedures to facilitate the safe disposal of the device and all materials (including sample containers and used kit contents) which could be contaminated with infection or microbial hazards, such as potentially infectious substances of human origin. Clean area where samples have been handled.

If there is no distinct coloured band visible in the control zone, the test is invalid. It is recommended that the test be repeated with a new test strip or a fresh specimen be obtained and tested 48 hours later with a new test strip.

Check4® Pregnancy test strips are capable of detecting hCG levels of 25 mIU/mL according to WHO 4th International Standard n° 75/589. The accuracy study was also performed by determining the qualitative recovery of known amounts of human chorionic gonadotropin added to the negative urine pool.

For more information on pregnancy you can visit the below:

• https://www.nhs.uk/pregnancy/
• https://www.gov.uk/browse/childcare-parenting/pregnancy-birth