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Pregnancy tests, ovulation, menopause… “sensitivity defects” observed on certain models

2024-03-12T13:13:16.463Z

Highlights: Pregnancy tests, ovulation, menopause… “sensitivity defects” observed on certain models. Out of 14 pregnancy tests, 5 would be “non-compliant”, specifies this service of the Ministry of the Economy. The study especially notes a “lack of sensitivity” on some models. “We cannot exclude a margin, even a very slight one, of uncertainty,” says Dr Joëlle Belaïche-Allart.


Some pregnancy tests show “sensitivity defects”, according to an investigation attached to the Ministry of the Economy. Rare abnormal


When in doubt, this is often the first action adopted.

Get a pregnancy test at the local pharmacy after a first missed period.

Without calling into question the effectiveness of these self-tests, “sensitivity defects” persist in certain models, observes the Directorate General for Competition, Consumer Affairs and Fraud Control which has scrutinized around twenty tests, 'after a press release published on Friday.

These checks were carried out, between September 2022 and July 2023, in around sixty establishments, ranging from pharmacies to large and medium-sized stores.

First result: out of 14 pregnancy tests, 5 would be “non-compliant”, specifies this service of the Ministry of the Economy, without disclosing the brands concerned.

The study first points to compliance problems, such as a “lack of instructions in French” or a “lack of CE marking” – which is nevertheless mandatory for all products covered by European regulatory texts.

After their use, certain “interpretation times” may still prove to be longer than those announced.

For example, a test may take “10 minutes” to detect the hormone in question, when according to its instructions, it should be able to do so in 5 minutes.

“A very slight margin of uncertainty”

More worrying, the study especially notes a “lack of sensitivity” on certain models.

In other words, the self-test could, in certain cases, not detect the hormone sought to confirm a pregnancy.

An observation that does not really surprise Dr Joëlle Belaïche-Allart.

Although most pregnancy tests have a reliability rate of around 99%, “we cannot exclude a margin, even a very slight one, of uncertainty,” she emphasizes.

In fact, pregnancy tests seek to detect HCG, chorionic gonadotropic hormone.

“It is a hormone secreted by the placenta which helps confirm whether the person is pregnant.

However, if the pregnancy is early, there will be a very low level of HCG in the blood and urine, which will prevent its detection by the device.

This is why patients can be pregnant despite a negative urine test,” explains the gynecologist for whom these “self-tests, even if they remain practical, cannot replace biological examinations.”

A blood test offered to confirm a pregnancy

To avoid a false negative, “we recommend that women take a second test 48 hours after the first and, if necessary, take a blood test to confirm these results.

Because even at low concentrations, the level of HCG will be detected,” adds Dr Mikaël Agopiantz, gynecologist and head of department at AMP (Medical Assisted Reproduction) at the Nancy CHRU.

Before recalling “the overall very high reliability of these tests used by a majority of French women”.

Another tab on the test bench, the ovulation test.

In this case, the DGCCRF investigation observed defects concerning “2 out of 6 tests”, noting a “lack of indication of performance”.

What is it about ?

“The ovulation test must detect a peak of LH (luteinizing hormone) in the person.

If the result is positive, ovulation is in progress.

But the test must in theory specify which LH threshold this positive result corresponds to, otherwise, it seems difficult for the person to see clearly,” notes Dr Mikaël Agopiantz.

If the ovulation test can be an “aid” to be used on “one or two regular cycles”, getting advice from a health professional in the event of a fertility problem “remains essential”, recommends the doctor.

Finally, the DGCCRF still notes anomalies concerning another type of screening, the lesser known one, which makes it possible to detect menopause.

Here again, it is a quick urine self-test, which becomes positive after the appearance of two colored lines on the tab.

A “lack of sensitivity” would also have been observed on certain models.

Nothing surprising in the eyes of Dr Mikaël Agopiantz, who doubts “the usefulness of such a device”.

“This screening seeks to detect a high level of follicle-stimulating hormone (FSH).

However, this rate increases at the time of menopause, but not only that.

We can observe a peak over several years before this phase!

Menopause takes place over several years, so the benefit of this test remains limited.

We are not here in a relationship of immediacy as with ovulation,” insists the doctor.

Source: leparis

All life articles on 2024-03-12

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