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The following is issued on behalf of the Hospital Authority:
The Hong Kong Red Cross Blood Transfusion Service (BTS) announced today (August 20) that Chiron, a Novartis company which supplies instruments and reagents for nucleic acid testing (NAT) world-wide, notified the BTS on August 15, 2008, that some of the reagents they had supplied to customers in Hong Kong and Asia Pacific regions would need to be recalled. According to Chiron, its appointed courier had, since November 2007, used a freezer for storing the reagents which had been found to show inconsistent temperature. Although there is as yet no evidence that the quality of the reagents has been affected, as a precautionary measure, Chiron has decided to recall the reagents that had been stored in that freezer during that time period. In the meantime, Chiron is performing a series of tests to validate the quality of the affected reagents.
Upon notification by Chiron on August 15, the BTS immediately ceased using the affected reagents and conducted an internal investigation and concluded the following:
1. According to the discussion result of the Hospital Authority (BTS) Expert Panel on Blood and Blood Product Safety, there is no evidence that the safety of the concerned blood products has been compromised. It is therefore unnecessary to recall the blood products that had been tested with the concerned reagents. This decision is the same as that taken by the other concerned countries involved in the recall.
2. The concerned reagents normally have an active shelf-life of 30 days following thawing. Chiron has confirmed that the affected reagents used within 12 days of storage are performing normally. In reviewing the blood samples tested with the concerned reagents in the past 10 months (from November 2007 to August 2008), the BTS confirms that 98.2% of the samples were tested with the reagents that fell within the acceptable 12-day storage period. In addition, a total of 1,722 samples were identified to require re-testing. As of today, all these samples have been retested and no discordant result has been identified. All blood products are therefore confirmed to have met the BTS”¦s testing requirement and are suitable for clinical use.
3. According to BTS standard procedure, quality control samples are applied during testing of each sample and each batch of samples. Review of the laboratory testing records of the controls using the affected reagents did not show any deviations from the normal expected results.
4. The BTS has also subscribed to an internationally recognised Quality Assurance Programme (QAP) to ensure the tests conducted are within acceptable standards. A review of QAP records did not show any abnormal results.
5. The above mentioned blood units have already passed infection screening for HIV, HCV, syphilis and HTLV antibodies and HBsAg, which are the mandatory tests for the release of blood for transfusion.
The BTS reiterates that the concerned blood samples in this recall exercise are confirmed to have met the BTS”¦s testing requirements and the blood products are suitable for clinical use. Chiron will continue to investigate the incident and keep the BTS informed of the progress of the investigation and also of any corrective actions required to prevent similar future problems. The BTS will closely follow up all aspects of this issue with Chiron and other concerned countries.
Remarks: Nucleic Acid Test (NAT) is a laboratory test of blood donations for HIV and hepatitis B and C viruses in addition to the routine infectious disease screening as stated in Point 5 above.
Ends/Wednesday, August 20, 2008
Issued at HKT 17:45
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