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WHO-provided COVID-19 test kits, made in Germany, the same as those in 120 other countries
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“A recent press statement issued by local health authorities in Sana’a over the weekend made mention of the “ineffectiveness and inefficiency” of the solutions and swabs that are part of the COVID-19 PCR testing kits provided to Yemen. The statement went on further to say that as a result of this, false positive results were generated when “non-human and unexpected samples” were tested, the findings of which would be revealed by local health authorities in a press conference in the coming days.
As a matter of clarification, the batch of almost 7000 COVID-19 test kits provided to Yemen by WHO, are the same PCR test kits provided to over 120 countries. WHO provided over 6 million PCR test kits to 120 countries worldwide, and an estimated 2 million of these kits were manufactured by TIB Molbiol, a company based in Germany. The TIB Molbiol PCR test kits are the ones Yemen received.
The importation of all medical supplies, medical equipment and consumables is subject to approval by health authorities.
Criteria for use and wide distribution of PCR test kits
The WHO engages in rigorous criteria when adopting a test for use and wide distribution to its Member States. The WHO criteria for a test provider, at the time the decision was made to work with this particular manufacturer, TIB Molbiol, included ensuring that this company and its products met ISO standards. ISO standards are used by countries worldwide to ensure that quality and safety of products and services destined for international trade meet global standards. The PCR test kits manufactured by TIB Molbiol met ISO standards (ISO: 13485) for quality manufacturing. The kits were tested and validated by three external laboratories, and the validation results were published in a peer reviewed journal. “