Faced with the health contingency due to coronavirus, the Federal Commission for the Protection against Sanitary Risks (Cofepris) reiterated its support for IgG and IgM serological tests to detect the presence of the SARS-CoV-2 virus.
In coordination with the National Institute of Nutrition and Medical Sciences “Salvador Zubirán” the body recently attached to the Undersecretariat of Prevention and Health Promotion established a protocol to ensure the effectiveness of the results of also known as rapid tests.
Due to the growing distrust generated by these tests to diagnose coronavirus, the Cofepris assured that the 19 tests authorized by the agency have the sensitivity, specificity and accuracy required for its use.
“COFEPRIS, at all times, supports its decisions and regulatory actions with technical-scientific evidence, on which the authorization of tests to detect antibodies against the SARS-CoV-2 virus is based, which, according to the evaluation made by the National Institute of Nutrition and Medical Sciences “Salvador Zubirán”, have the required sensitivity, specificity and accuracy”, Says a release of said governmental body.
However, the Undersecretary of Prevention and Health Promotion, Hugo López-Gatell, said at the evening press conference last Thursday that the Ministry of Health (SSa) does not recommend the use of tests serological to detect COVID-19 despite the fact that the National Commission for the Protection against Sanitary Risks (Cofepris) authorized its sale and distribution in Mexico.
From the National Palace, the official pointed out that the rapid tests they have a “very limited” ability to detect antibodies against the SARS-CoV-2 virus.
The Mexican Ministry of Health does not recommend the use of rapid tests. Cofepris, which is a public body, a decentralized body of the Ministry of Health, authorized the sale or distribution in Mexico in private systems, because they have a certain limited capacity, very limited, to detect antibodies against the SARS-CoV-2 virus, but the capacity is so limited and the consequence of a limited capacity of all the rapid tests that have been authorized in the territory is so unfortunate that the Ministry of Health does not recommend the use of rapid tests
In addition to this, Cofepris alerted the population about the Risks of Using Rapid Tests to Detect Coronavirus Disease that do not have the endorsement of the agency.
The use of serological tests that are not authorized represents a risk since they could lead to wrong decision-making, when using a test whose results generate an inaccurate interpretation, regarding the possible presence of antibodies against the SARS CoV-2 virus.
In this sense, The agency called on the population to ask that before acquiring or performing a serological test, verify that it is in the dependency list. In case of identifying that the exam is not endorsed, the citizen shall make a Health Report.
Cofepris endorsed its commitment to ensure that products, companies or establishments comply “With current health legislation and do not represent a risk to the health of the population, we must remember that in this effort we are all health guards.”
On the other hand, in response to the coronavirus epidemic in Mexico and with the aim of avoiding a shortage of medicines, Cofepris determined that health managers in pharmacies must request a prescription to people who wish to acquire any of the following medicines to treat the disease of COVID-19 on an outpatient basis:
Hydroxychloroquine / Chloroquine
In this sense, the health agency pointed out that the personnel in charge of dispensing them must bear in mind the legal provisions applicable to the sale of medicines, which They are mandatory for all establishments called pharmacies, pharmacies or drugstores, described in article 257 of the General Health Law. These businesses are the only ones that will be able to offer them or provide them to the population.