It is a movement of substance
The genie is out of the magic lamp of industrial biological analysis and there will not return. Each of us, with or without the advice of her doctor, can now order a self-test on a site of sale by correspondence (8 to 40 euros depending on the tests) and push the door of a pharmacy to buy one. Which one? Who is it for? With what precautions?It is to these questions that the Academy of pharmacy has sought to respond in a report (available online as of 24 January), which also focuses on the rapid testing guidelines diagnostic (TROD). “At the present time, the tendency is that the patient is an actor of his health,” says the Figaro Dr Liliane Grangeot-Keros, the coordinator of the working group of the Academy, which welcomes this development, “but it is necessary to ask the following two questions: are they reliable and are they relevant?”. “At the present time, the tendency is that the patient is an actor of his health,” Dr Liliane Grangeot-Keros, the coordinator of the working group of the Academy the Academy passes in review 13 self-tests the CE marking (european Conformity) sold in a pharmacy. It excludes those who do not have the CE marking, and are sold without any control.
Among the 13 self-tests considered, the report gives a green light to 3 of them, are considered to be useful, self-tests for HIV, the immunization status against tetanus, and urine strips can detect a urinary tract infection, proteinuria (albuminuria) and a glucose (sugar). The five tests remain to be validated according to the report, the cholesterol, the research of iron deficiency, hypothyroidism, and self-tests of ovulation or menopause.
“The self must not simply be taken on the shelf of the pharmacist, it is necessary to support the pharmacist that explains how to achieve and, above all, which places the patient in a course of care that either the laboratory or the doctor or the nurse,” insists Karen Wolf-Thal, president of the national Council of the order of pharmacists (CNOP).
All the more that the interpretation is not always obvious.
The Academy suggests to avoid 5 self-tests: PSA (prostate cancer), Helicobacter pylori (bacterial infection of the stomach), total IgE (up to sign an allergy), Borrelia (Lyme disease) and search for blood in the stool (colorectal cancer screening). For this last screening, the Academy suggests to turn to the formal testing, while regretting that the pharmacies could not be a point of entry into the device for those interested. Notice of five instances différentesIl is true that the examinations of medical biology conducted at the laboratory are subject to very strict control. They must first be subjected to the opinions of five different instances*.
The requirements are understandable in view of the importance of laboratory testing for the medical interpretation of a situation. The case of the self-tests, the drug Agency (MSNA) wants to be reassuring: “The CE marking may only be affixed by the manufacturer after obtaining a certificate of conformity issued by a third party organisation, called a notified body. Thus, no self-test may not be placed on the market without a compliance audit of its screening by a third-party organization. ” The MSNA also conducts compliance checks of reagents, they are used directly by the general public (self-tests) or in the laboratory of medical biology.
Is this enough? “The CE marking is a necessary but probably not sufficient,” Dr. Grangeot-Keros “The CE marking is a necessary but probably not sufficient,” says Dr Grangeot-Keros. It is right that learned societies to verify the reliability of the tests, their sensitivity (ability to identify an anomaly), their specificity (to avoid to find a fault where there has not) and their reproducibility.
” This is also the opinion of Karen Wolf-Thal, president of the national Council of the order of pharmacists (CNOP), “and even if these are tests of orientation and not of the diagnostic tests, there is no denying that they can be responsible of unjustified anxieties or delay the consultation of a health professional”. * The High authority of health (HAS), the Commission of a hierarchy of acts of medical biology (CHAB), the Directorate-general of the organization of care (DGOS), the national Commission of medical biology (CNBM) and the national Board for professional medical biology (CNPBM). . .