Objective: To determine the sensitivity and specificity of tests for hepatitis B surface antigen (HbsAg), hepatitis C virus (HCV), and syphilis conducted by laboratories of 3 blood collection organizations in a rural area of China.
Methods: From October to December 2003, 1068 samples were collected from blood donors presenting to the 3 collection centers. All samples were tested twice using 2 different test kits for HBsAg, HCV, and syphilis. An aliquot was sent to the China National Center for Clinical Laboratories to confirm the local test results. Sensitivities and specificities of the 3 local blood centers/banks were calculated using the results of the National Center for Clinical Laboratories as the gold standard.
Results: The sensitivity of the 3 blood collection center/banks ranged from 0% to 63.2% for HBsAg. For HCV, the sensitivity was 0%, and for syphilis, ranged from 0% to 85.7%. There were no HBsAg positives in one of the blood center/banks, and no syphilis positives in the other. Thus, sensitivity could not be measured for these tests in these 2 facilities. Combining all 3 tests, the overall sensitivity was 55.6%. The specificity was 100%.
Conclusions: The sensitivity of the local laboratories was inadequate and could cause possible infection for an unacceptable number of blood recipients. Action needs to be taken to improve the quality of testing to ensure the safety of the rural blood supply.