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Tanzania: WHO Approves Korean HIV Rapid Test Kits Suspended in 2011

A South Korean made HIV rapid test kit, SD Bioline HIV 1/2 3.0 whose use was suspended in 2011 by World Health Organization due to accuracy concerns has been pre-qualified for use by member countries.

WHO Department of Essential Medicines and Health Products Director, Mercedes Gonzales said the rapid test kits have been re approved following corrective measures taken by Standard Diagnostics Inc., of South Korea which manufactures the kits.

"Following our guidance and advice, Standard Diagnostics took a number of corrective measures to improve their test's quality and the product was subsequently prequalified on May 20, 2013," Mr Gonzales told 'Daily News' in an emailed response to questions sent.

Ministry of Health and Social Welfare suspended use of SD Bioline HIV rapid test kits immediately after WHO suspended them from its pre-qualified list of kits in 2011, following discovery of defective lots which did not give correct readings.

In its evaluation report released in 2013, WHO said the pre-qualification of SD Bioline follows thorough investigations which included site visits of the global health body's experts to make sure that major changes have been made to guarantee safety and standards.

"SD Bioline HIV-1/2 3.0 was accepted for the WHO list of prequalified diagnostics on the basis of data submitted and publicly available information in May 2013," the global health body's report stated. Standard Diagnostics Inc. submitted an application for prequalification of SD Bioline HIV-1/2 3.0.

Based on the established prioritization criteria, SD Bioline HIV-1/2 3.0 was given priority for prequalification. "The information submitted in the product dossier was reviewed by WHO staff and external experts (assessors) appointed by WHO in accordance with the internal report on the screening and assessment of a product dossier.

Based on the product dossier screening and assessment findings, a recommendation was made to accept the product dossier for SD Bioline HIV -1/2 3.0 for prequalification," the WHO report said.

The WHO experts report further noted that its inspectors visited the Korean manufacturer's factory to see the equipment used.

"A comprehensive second re-inspection was performed at the sites of the legal manufacturer of SD Bioline HIV -1/2 3.0 at 156-68 Hagal-dong Giheung-gu, Yongin-si, Kyonggi-do 446-930, Republic of Korea and 473-4 Bora-dong Giheung-gu, Yongin-si, Kyonggi-do, 446-904, Republic of Korea in November 2012," the report noted.

The inspection was based on 'ISO 13485:2003 Medical devices - Quality management systems -Requirements for regulatory purposes' and other internationally recognized standards relevant to the manufacture of in vitro diagnostics, the WHO report noted.

The manufacturer has committed to continuing improvements in the quality management system particularly in the areas of clear lines of authority, identification and traceability, warehousing and clarity of work instructions and batch manufacturing records, the report concluded.

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