RELEASE

Since the beginning of the COVID-19 pandemic, Medical Analysis Laboratories in the public and private sectors have ensured the continuity of their services throughout the national territory despite the difficulties in supplying personal protective equipment.

In addition, they have expressed, on many occasions and through the representative bodies of the profession, their unconditional support for the efforts of the Ministry of Health in the fight against the spread of SARS-COv2 among the Tunisian population.

The cornerstone of the diagnosis of COVID-19 being the search for viral RNA, the university hospital medical laboratories designated by the Ministry of Health have taken part in this effort.  The hospital laboratories in all specialties participate in the management of hospitalized patients by performing follow-up assessments. Laboratories from the private sector have made their equipment available to hospital laboratories for the performance of PCR. On the other hand, medical biologists have made every effort to contribute their expertise to develop national recommendations on biosafety and the use of diagnostic tests.

Unfortunately, we were very surprised to note that as of April 23, 2020, rapid tests were used under the aegis of the Ministry of Health, without the involvement of the medical biologist.  In this context, we recall that Law n° 2002-54 of June 11, 2002, relating to Medical Analysis Laboratories stipulates in its Article 2 that human medical biology analyses can only be performed under the responsibility of a medical biologist or a pharmacist biologist or, failing that, by a laboratory technician under the technical supervision of a biologist. Moreover, the use of these tests did not comply with the manufacturer's recommendations, generating false negative results that may have serious consequences for public health.

We call on the authorities to:

-    Involve medical doctors and pharmacist biologists in the diagnostic process, regardless of the nature of the test used. Indeed, they are the only guarantors of the correct execution and interpretation of medical analyses.

-    Involve the members of the Technical Committee of Medical Biology with the Unit of Biology Laboratories in the evaluation of rapid screening tests as it is usually the case for any biological test marketed in Tunisia through medical biology laboratories experts in the field, to judge its sensitivity and specificity before its widespread use. We recall in this respect that according to the Decree n°2002-1733 of July 29, 2002, the Technical Committee of Medical Biology has the mission to participate in the conception, reflection and evaluation in the field of medical biology.

The president

Professor Taieb Ben Messaoud