Non-compliant labeling, sensitivity defects… Anomalies detected in fertility self-tests

Non compliant labeling sensitivity defects Anomalies detected in fertility self tests

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    in collaboration with

    Dr Yves Dour (Doctor of Pharmacy)

    Medical validation:
    March 22, 2024

    Last week, the Directorate General for Competition, Consumer Affairs and Fraud Prevention published the conclusions of its investigation into the sensitivity of urinary self-tests for pregnancy, ovulation and menopause.

    Bad news for all women who are trying to get pregnant or who are going through menopause: the urinary self-tests for pregnancy, ovulation and menopause, sold in supermarkets and pharmacies, are not all reliable. The DGCCRF’s investigations have in fact highlighted sensitivity defects on certain products.

    9 tests were deemed non-compliant

    During this investigation, carried out between September 2022 and July 2023, the DGCCRF wanted to verify the performance of the famous tests – as well as all the information necessary for their proper use.

    The checks focused on the conformity of the labeling and the instructions, including the presence of instructions in French. The sensitivity of the self-tests was also measured – that is, their ability to detect or not detect hormones in urine within a given time.

    In total, checks were carried out at 59 establishments (manufacturers, pharmacies, large and medium-sized stores).

    Result ? Of the 22 products analyzed and tested in the laboratory “9 samples were deemed non-compliant“, specifies the DGCCRF.

    • 5 non-compliant pregnancy tests out of 14, due to lack of sensitivity, absence of CE marking, and absence of instructions in French;
    • 2 non-compliant ovulation tests out of 6, for lack of indication of performance and incorrect contact details of the manufacturer;
    • 2 non-compliant menopause tests out of 2, due to lack of sensitivity and absence of instructions in French.

    The lack of sensitivity covers two types of situations: either the test does not detect the hormone sought at the concentrations announced on the packaging or the leaflet, or it takes longer to detect it than what is indicated in the instructions. job. For example, a package might say a reading time of 5 minutes, but the test was only able to detect the hormone after 10 minutes. This anomaly affected nearly a third of the products“, reveals the DGCCRF. The problem? “These non-compliances can lead users to believe that they are not pregnant when they are..”

    NO to diets, YES to WW!

    The price of the test influences its quality

    Conclusions, which only half surprise Dr Dour, interviewed on this subject.

    The problem is that you can buy a pregnancy test absolutely anywhere, in pharmacies or supermarkets. However, manufacturers distribute tests for less than 2 euros per box. At this price, is the plastic compliant? Is the sensitivity consistent? I doubt. It’s a question of profitability. For these tests, the quality of the product varies depending on the price“, he says.

    Conversely, in pharmacies, products comply more with standards.

    In absolute terms, and if you are serious as a pharmacist, you will only find products sold under the pharmacy label in pharmacies. In other words, products in French, with the reliability that we know, or stamped “CE” (European marking)”, assures Dr Dour, who invites users “to check these quality criteria directly on the packaging“.

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