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BRASÍLIA – The National Institute for Health Quality Control (INCQS) failed rapid tests for the diagnosis of dengue zika and chikungunya purchased Ministry of Health and were in use in the United States. After complaints from Minas, São Paulo, Rio, Acre and Goiás, many lots were sent for badysis. The result indicated low lot sensitivity, indicating a risk for the patient with the disease to be considered healthy.
The INCQS award was completed in December and, as a result of the result, the department has determined further badysis. Now the test will be done with lots distributed to all states. This is one of the tests used by the Unified Health System (UAS).
Bahiafarma, the public laboratory that conducted the tests, was informed of the result. The National Health Surveillance Agency (Anvisa) has also been activated and opened an investigation.
The Ministry has twice acquired the diagnostic tests of Bahiafarma. The first batch of R $ 119 million was purchased in 2016, a year after the big outbreak of zika in the country, under the control of the then deputy, the Minister of Health, Ricardo Barros . (PP-PR). In 2017, 6.5 million tests were acquired, this time on dengue, zika and chikungunya, for an amount of about 162.5 million rand.
The second contract tests were distributed throughout the country in 2018. Throughout the year, some state laboratories sent technical reports indicating inconsistencies in the kits. Subsequently, an badessment was requested in INCQS. Complaints were also made at meetings of state secretaries and municipalities with the ministry.
Pending final results, some states have suspended the use of Bahiafarma kits. The Superintendency of State Health Surveillance said that even if the product was in use, deficiencies were identified. The biggest suspicion was the false negative results, as INCQS points out.
Defense. Bahiafarma President Ronaldo Dias said he had not been informed before of the INCQS review. According to him, it is the practice of the producer to follow the process and make a counterclaim.
Without supervision, he added, there is no way to ensure that problems are not caused by improper storage or transportation. "Why has not all this time sent formal notification of suspicion of effectiveness?"
Dias noted that many states did not use what the ministry had mentioned. "There was resistance, maybe state found that the biggest dissatisfaction among states was that the test required the establishment of a certain structure. who are usually ready as soon as the material to be examined is put in contact with the kit, the Bahiafarma examination would require treatment, which is not available in all health centers.
The Ministry has indicated that there may be an expired stock among the reviews sent to states, but it has not specified how many.There are 600 160 dengue testing tests in pulp warehouses; tests for zika and 659,660 tests for chikungunya.Already sent 1,237,420 tests for dengue, 738,750 for Zika and 906,960 for chikungunya.This is only after the completion of new quality tests you will know what it is possible to do with the exams and Bahiafarma
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