The National Center of Bio-preparations (Biocen), obtained the authorization for the Emergency Use of the Universal Transport Medium(BTU) as a new efficient alternative for the collection and transport of clinical samples suspected of containing the SARS-COV 2 virus, which caused the Covid-19 pandemic.

The novel product guarantees the continuity of the diagnosis of the disease and the epidemiological surveillance in the country, before real difficulties in the importation of some inputs for the production of the BTV, device developed in 2020, said to press Marilyn Díaz Pérez, Head of the Group of Microbiological Diagnosis of Biocen.

Its ingredients are much more feasible to reach and import, it is composed of a mixture of salts, some buffering agents, antibiotics and sources of essential amino-acids and proteins, she pointed out.

He stressed that in terms of cost-benefits it will make it possible the substitution of imports and the saving of foreign currency due to its concept of technological sovereignty by having a simpler composition, that will allow keeping active the Epidemiological Surveillance System in Cuba.

Likewise, she added, it provides early confirmation of the disease though molecular biology techniques that are more sensitive than rapid tests and can be used in tests such as the UMELISA.

The doctor in Sciences explained that the BTU was validated with 156 clinical samples of nasopharyngeal exudates from patients suspected of having the new Coronavirus with positive antigen test or prior confirmation as positive to Covid-19, obtaining results equivalents to the BTV medium, widely used in the national territory.

It reached a satisfactory degree of concordance and without significant differences with respect to the result of the diagnosis by rt-PCR for SAR-COV 2, using different platforms of RNA extraction and analysis by rt-PCR and in particular with the RNA extraction kit of national production developed by the Center of Advanced Studies.

Díaz Pérez also explained that the BTU proved to guarantee adequate preservation of the viral load of clinical samples for 72 hours under refrigeration at a temperature of 2 to 8 degrees Celsius, allowing the re-essay of the samples and their transport between provinces.

CEDMED granted the approval for Emergency use and the license of its production at Biocen, where it is developed in compliance with high international quality standards supported by a management system certified by the ISO-9001 standard of 2015.

The experts foresee the distribution of 300 000 units of the diagnostician per week as the production campaign progresses, which is already underway with the manufacture of the first batches on an industrial scale.

The head of the Microbiological Diagnostics Group added that the BTU will continue to be evaluated with a view to obtain its sanitary registration as a diagnostician and incorporating it into the list of products offered by the center to its clients.

She also informed that, the efficacy of the Essential Transport Medium, another presentation of the diagnostician, simpler than the BTU but with equally satisfactory results, is being evaluated.

We have already obtained some pilot batches and we are evaluating its performance with clinical samples for which we have coordinated with some hospitals for cooperation.

In April 2020, Biocen developed in one week the BTV, the first Cuban produced virus transport vessel for the collection, transport and maintenance or samples of Covid -19 patients until they were processed in the molecular biology laboratories.

The results were very favorable, being equivalent to those obtained with reference or imported products that already existed for the diagnosis, and in addition, a swab was developed by the Neurosciences Center for sampling and diagnosing which was also evaluated.

The BTV was designed to respond to the means of transport for the Covid-19 and its composition was based on international means, however, the BTV was enriched with other components to make it universal and useful not only for virus, but also for other microorganisms. 

(Taken from ACN)