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Rapid and qualitative
low sensitivity self-test

For medical termination of pregnancy and miscarriage follow-up

Key Benefits

Accurate

checkToP® is a very accurate qualitative test conceived to detect hCG levels above 1000 mIU/mL.

Its sensitivity makes it possible to confirm the success of medical termination of pregnancy up to 9 weeks of amenorrhea and miscarriage 1,2.

Reliable

checkToP® can detect hCG levels above 1000 mIU/mL in over 99% of cases 3.

Rapid and easy to read

The results are displayed within 5 to 10 minutes in the form of bands in the device window for an easy way to read a negative or positive result 3.

Convenient

checkToP® allows remote follow-up of medical abortion.

checkToP® has good follow-up rates and satisfaction expressed by women 4.

checkToP® is a popular choice for women: a convenient tool.

  1. Cameron ST et al. Telephone follow-up and self-performed urine pregnancy testing after early medical abortion: a service evaluation. Contraception. 2012 Jul;86(1):67-73.
  2. Clark W et al. Alternatives to a routine follow-up visit for early medical abortion. Obstetrics and Gynecology. 2010 Feb;115:264-272.
  3. checkToP® instruction for use

checkToP® acceptability and satisfaction4

Healthcare practitioners report

of patients are satisfied using checkToP®

of patients are reassured using checkToP®

of patients find checkToP® very simple / simple to use

of healthcare professionals are satisfied using checkToP® for medical abortion follow-up

4. Urine test for medical abortion follow-up during the COVID-19 pandemic: Results of the IMPACTT survey on practices and role of the test. 2020. N. Trignol-Viguier, A. Agostini (n=39 Health Care Professionals)

Product information

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Content of the pack

Each pack contains one instruction for use and one checkToP® test packaged in a hermetically sealed aluminium pouch containing one desiccant sachet.

Product specifications

checkToP® is an in vitro diagnostic medical device of class B5.

checkToP® test is not a classical pregnancy test. checkToP® is a low sensitive urinary rapid test for the determination of the hCG (human Chorionic Gonadotropin) level in urine, to determine the outcome after a previously confirmed Termination of intrauterine Pregnancy (ToP) up to 9 weeks of amenorrhea and miscarriage.

checkToP® is designed to detect urinary hCG levels ≥ 1 000 mIU/mL, which makes it an appropriate device for medical termination of pregnancy follow-up between 10 to 20 days after the first drug intake in medical termination of pregnancy or miscarriage.

The concentration of hCG and ß-hCG in urine are similar to or slightly higher than those of serum 6

Tests with detection limits of 1 000 mIU hCG/mL or higher are usually negative 2 weeks following complete induced abortion 7.

ß-hCG levels drop rapidly under 1 000 IU/L after abortion 8

Disappearance curves of serum ß-hCG

Women (n=36) who had elective vacuum aspiration abortions at 7-13 weeks since last menstrual period (LMP) (top curve)

Women (n=35) with spontaneous abortions at 6-15 weeks LMP treated with uterine aspiration (bottom curve)

5. Regulation 2017/746 Annex VIII Rule 4a

6. Stenman UH et al. The classification, functions and clinical use of different isoforms of HCG. Human Reproduction Update. 2006 Nov-Dec;12(6):769-784.

7. van der Lugt B et al. The disappearance of human chorionic gonadotropin from plasma and urine following induced abortion. Disappearance of HCG after induced abortion. Acta Obstet Gynecol Scand. 1985;64(7):547-52.

8. Steier JA et al. Human Chorionic Gonadotropin in Maternal Plasma After Induced Abortion, Spontaneous Abortion, and Removed Ectopic Pregnancy, Obstetrics & Gynecology 1984; 64(3): 391-394

How to use

The test must be performed after Termination of Pregnancy at a time indicated by your gynaecologist, usually between 10 to 20 days after:

• the first drug intake in medical abortion
• miscarriage

Always read the instruction leaflet carefully before testing.
• Remove the checkToP® test device from the aluminium foil pouch. Discard its small sachet
• Remove the cap and either:

Hold the absorbent tip directly in your urine stream for 5-10 seconds. Take care no urine enters the test.

Or collect your urine in a clean and dry container and dip the absorbent tip into the urine for at least 5 to 10 seconds in order for it to be completely soaked.

• Replace the cap on the test device.
Lay the test device on a dry flat surface with the two windows facing up.

Wait between 5 to 10 minutes to read the test results. Between 5 to 10 minutes a line will appear in the control window (the smaller window).

Important: Do not read before 5 minutes or after 10 minutes.

Within 5 to 10 minutes, your results will be displayed in the windows. The results read as follows.

Negative test result: Your ToP is confirmed

If only one pink colored band appears in the control window (the smaller window) and no band appears in the test window (the largest window), the test is negative. Termination of Pregnancy or miscarriage is confirmed.

Positive test result: Your ToP is not confirmed

If two pink colored bands appear within 10 minutes, one in each window, the test is positive.
Your hCG level may be above 1000 mIU/mL. This could mean that the treatment for Termination of Pregnancy may not have worked or is not complete, or that miscarriage has not occurred.

In any case you should consult your physician.
Note: One band can be darker than the other. The two bands can be any shade of pink-purple and can be lighter or darker than the control. However, you should see two clear parallel bands.

Inconclusive test results: Repeat your test in 24 hours

OR

The test is inconclusive if there is no coloured band in the control window, with or without a band in the test window.
It is recommended to repeat the test with a new checkToP® on a fresh urine sample obtained 24 hours after the inconclusive test.

Resources

Download information and other documents

checkToP® notice

Instructions for use

Patient card

Healthcare professionals card

This video describes the follow up step, 14 to 21 days after the start of the pregnancy termination. The control is done by ultrasound or by urinary control. In the case of a urinary control, the doctor may have to use the medical device checkToP®.

EXELGYN provides healthcare practitioners with the complete method to medically terminate pregnancy up to 49 DA.

Safety comes first

Even if the test confirms the termination of pregnancy, you should still contact your physician if you experience the following symptoms :

No bleeding or limited bleeding since the last treatment intake

Tummy growing

Feeling sick

Tender breasts

No period by 1 month after treatment

safety-6

Consult your physician for a follow-up examination

No bleeding or limited bleeding since the last treatment intake

Tummy growing

Feeling sick

Tender breasts

No period by 1 month after treatment

Consult your physician for a follow-up examination

Questions & answers

When a woman becomes pregnant, her body begins to produce a hormone, human Chorionic Gonadotropin (hCG), which is excreted in the urine where its concentration rises over time. The checkToP® test uses a pair of antibodies specifically detecting the hCG hormone in urine to check whether the hormone level is 1000 mIU/mL (determined against W.H.O.* reference) or greater. If treatment for Termination of Pregnancy has been effective or miscarriage has occurred, then the hCG level should drop below 1000 mIU/mL within 10 to 20 days. checkToP® will not detect hCG levels lower than 1000 mIU/mL while classical pregnancy tests will be positive.

*World Health Organisation

Yes, we recommend testing checkToP® on the first morning urine as it should be more concentrated.

Yes, a high fluids intake may dilute the urine and make the hCG detection more difficult. Abnormal fluid intake is therefore not recommended.

If you are unable to determine whether or not a line is present in the oval test window, repeat the test after 1 day with a new checkToP® test.

If you follow the instructions, you should get accurate results. Certain drugs which contain hCG or that are used in combination with hCG (such as Pregnyl®, Profasi®, Pergonal®) and rare medical conditions may give a false positive result. Alcohol, analgesics, antibiotics, birth control pills, hormone therapies containing clomiphene citrate (such as Clomid®, Serophen®) or painkillers should not affect the test result.

You must follow the advice given by the medical staff managing you.

If you read the test before 5 minutes, you may not give the test enough time to work, and the test result may not be accurate. DO NOT INTERPRET the results if 10 minutes have elapsed after having brought the absorbent tip into contact with urine.

The checkToP® is very accurate and has been used by health care professionals to confirm the success of Medical Termination of Pregnancy up to 9 WA (hospitals and laboratories). Evaluation reports show that checkToP® can detect hCG above 1000mIU/ mL in over 99% of cases3. No test is perfect and even if the test is negative, you should still contact your health care provider if you have symptoms of pregnancy such as no or limited bleeding, no period at the expected time, tender breasts, feeling sick, or tummy growing.

Yes but checkToP® is not able to detect very early pregnancies and only shows positive if the hCG hormone is more than 1000 mIU/mL.

Other pregnancy tests are more sensitive and give a positive result starting from 5 to 25 mIU/mL.