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Author Topic: TESTS ALERT!!!  (Read 1817 times)

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Offline nursepoz24

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  • Posts: 28
TESTS ALERT!!!
« on: June 10, 2012, 10:25:09 AM »
31st December 2011
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http://www.ippmedia.com/frontend/index.php?l=36958

Chief Medical Doctor, Deo Mtasiwa

While the World Health Organisation (WHO) alert on the invalid rapid HIV test kits ‘SD Bioline’ went out last month to all Global Funds recipient nations including Tanzania, the kits are still is use in the country.
Reliable sources told The Guardian that the kits were still in use in the country raising fears that many people might have been affected. The Guardian yesterday inadvertently referred to the kits as ARV drugs.
The test kits SD Bioline HIV-1/2 3.0 which Tanzania has registered as the main testing devices have proved failure worldwide, according to the WHO’s field safety notice issued on November 16th, 2011.
When called to clarify on action taken after the alert on the devices, the Permanent secretary ministry of health and social welfare, Blandina Nyoni said she was attending a meeting and that she would call later, but until we went to press she had not called. Efforts to reach the Chief Medical Doctor, Deo Mtasiwa also proved futile as his phone went unanswered

.
Some of the electronic reports available to The Guardian show that the Ministry of Health and Social Welfare officials received the WHO alert on the said kits last month.


The Global Fund note read: “We are aware of the disruption for programmes if the use of this product is stopped now; however, the use of defective RDTs could be extremely detrimental and therefore we recommend the PRs to take immediate action.
The source warned of the negative implications for those tested using the defective kits: “If a hundred people tested HIV/Aids, and were told that they were negative, because the test kits didn’t function well, then these people might be positive.”
He said blood taken from such people who might be positive and given to others such as pregnant mothers in need of transfusion, thus affecting the mothers and their unborn babies.

There is also the danger of pregnant mothers being wrongly tested HIV/Aids free and so infecting others including doctors and their infants.


 “People are aware of the implications of procuring items from a single source. This must be a lesson to our leaders,” said the source, adding: “So many people might have been affected by trusting that the kits were okay, while in actual fact they were not.”


The rapid test kits on two separate numbers SD Bioline (023419 and 023418B) with expiry dates August 30th, 2013 and August 2nd, 2013 respectively, have been de-listed from the WHO e-catalogue and will therefore not be eligible for procurement by WHO and UN agencies, until further notice.
Last month’s WHO statement posted on its website states that recent laboratory evaluations revealed a high rate unacceptability of the testing kits manufactured by Standard Diagnostics in the Republic of Korea.
Similar problems were observed by The Partnership for Supply Chain Management (PSCM). They discovered problems with the SD Bioline HIV-1/2 3.0 (product code 03FK16) lot number 023424B with expiry date August 18th, 2013 and lot number 023425.


The product is bought by several countries including Belarus, Benin, Burkina Faso, Honduras, India, Jamaica, Liberia, Malawi, Mongolia, Nepal, Philippines, Rwanda, Sierra Leone, Somalia, South Africa, Sudan, Tanzania, Togo, Ukraine and Zimbabwe.
Global fund which informed its recipients in Tanzania of the quality issue with the HIV Rapid Diagnostic Test SD Bioline HIV-1/2 3.0 (product code 03FK10) manufactured by Standard Diagnostics (Republic of Korea) said they had been alerted by PFSCM (VPP procurement agent) of a problem during quality control testing of the SD Bioline HIV-1/2 3.0 (product code 03FK10) manufactured by the firm.
“The problem relates to an unacceptably high rate of invalid test devices. This problem has been detected in several lots,” they said referring to Joelle Daviaud or Carmen Perez Casas of the Global Fund for more information.
“We immediately contacted the WHO Prequalification of Diagnostics programme, our technical partner in WHO for all diagnostics quality issues and they were able to confirm that they had observed a similar problem during re-assessment for prequalification,” they said, adding: “WHO contacted the company and instructed them on a course of action to investigate the quality issues. These investigations are still undergoing.”
It is understood that the company is voluntarily recalling several lots that were also detected as defective, and that SD Bioline HIV-1/2 3.0 (product code 03FK10) has been de-listed from the “List of HIV diagnostics eligible to tender for procurement by WHO in 2011”,  and therefore can no  longer be purchased with the Global Fund resources.


“The Global Fund recommends that Principal Recipients (PRs) should suspend all pending orders for SD Bioline HIV-1/2 3.0 (product code 03FK10) manufactured by Standard Diagnostics and those who have procured and are using this product should follow the recommendations issued by WHO Prequalification of Diagnostics programme and recall the following affected lots , as indicated by the manufacturer Standard Diagnostics: 023426B, 023427, 023427B, 023428, 023428B, 023430, 023430B, 023418, 02418B, 023419, 023424, 023424B, 023425B, contacting the manufacturer with filled form.”
The WHO also advised them to arrange for procurement of an alternative product and that selection was to be done depending on the country's national validated testing algorithm and Global Fund quality assurance Policy: including HIV diagnostic products eligible for procurement according to WHO evaluation and/or other products compliant with the Global Fund Quality Assurance Policy.
The Global Fund also asked the recipients to send information on batch number/s, quantity of tests in stock, and a copy of the national algorithm should there be stocks of other lots of SD Bioline HIV-1/2 3.0 (product code 03FK10) in the programme, - not specified in the note.


Meanwhile Medical Stores Department (MSD) was yesterday erroneously quoted on the matter as only the ministry of health and social welfare had the mandate to give the information.

Offline Andy Velez

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  • Posts: 24,623
Re: TESTS ALERT!!!
« Reply #1 on: June 10, 2012, 10:31:52 AM »
Stop posting the same thread in multiple forums. I have deleted the others and left this one still active as it seems the closest to being appropriate.
Andy Velez

 


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