1. Effects on diagnosis of HIV infection using two HIV rapid tests and linkage to ART in health facilities in China Hao Wu Director of infectious disease center, Beijing Youan Hospital whdoc@sina.com

2. Background  A newUNAIDS report revealed that 19 million of the 35 million (57%)people living with HIV/AIDS today worldwide do not know they are infected.  56% of HIV/AIDS don't know their HIV status in China 1.  Roughly 40%-50% of AIDS patients are diagnosed as AIDS in the first year when they are tested HIV positive 2  Around 50% of HIV infected persons are not identified until the early clinical symptoms present 3.

3. Purpose/Material/Method  Explore the effects of replacing China’s current HIV testing algorithm of ELISA + Western Blot (WB) with two HIV rapid tests and linkage to ART.  Two rapid test(RT) testing kits: Determine and SD, the two kits are imported.  Three hospitals in national, city and county level.  Study group: the HIV positives confirmed by two HIV rapid tests from April to August, 2013.  Control group: the HIV positives confirmed by ELISA+WB from November, 2012 to March, 2013 in the same two health facilities..

4. Main results  Sensitivity and specificity are all 100% for the testing way of two RT testing compared to ELASA+WB.  Two RT testing has more better sensitivity than ELASA+WB in diagnosing early infection.  Two RT testing can reduce the lost follow up rate of positive persons in HIV screening.  Two RT testing can reduce the interval time, simplify the procedure and push forward the linkage from screening to ART.

5. Confirmation of screening results of rapid tests Screening results n. screening n. confirmation Method of confirmation Result of confirmation +-± Determine (-) 125724479ELISA+WB04479 a 0 Determine (+) no SD 60---- Determine (+)+SD(-) 16 WB0142 Determine (+)+SD(+) 310304WB297 b 07 a 2 ELISA positive while WB negative and RT negative b 7 WB ‘+’ with initial ‘±’—uncertainty, Sensitivity is 100%, specificity is 100% for the testing way of Determine + SD

6. Loss-to-Follow-Up Rates of Positive Persons in HIV Screening During Control Period and Pilot Period Control period (N=241) Pilot period (N=177) Total (N=418) χ 2, p value Not lost to follow-up 227(94.2)171(96.6)398(95.2)1.311,0.252 Lost to follow-up 14( 5.8 )6( 3.4 ) 20(4.8) Reduced lost follow up

7. Percentage of HIV patients detected at early phase (CD4 counts over 350/mm 3 ) p=0.591 p=0.419 p=0.021 p=0.003 Percentage of WB positive patients receiving ART by CD4 counts

8. Time interval from screening to ART Days of ART initiation after screening

9. Conclusions  An algorithm of two HIV rapid tests can achieve closely comparable results to the traditional way of ELASA+WB.  HIV rapid tests, since they take less time, reduce the total time to enroll patients in care and treatment and conduct laboratory tests, which can increase linkage and ART uptake, it’s necessary and urgent to adopt it in health facilities in China.  The national guideline on HIV testing and diagnosis should be revised as soon as possible.

10. Thanks very much http://www.aidshealth.org Beijing Youan hospital team Jingsong Bai, the third people hospital of Kunming Hongsong, Li, Zhaoyang Longquan Community Health Service Center Lv Fang, Zeng Gang, NCAIDS, China CDC AHF-China AHF-Asia Bureau AHF-Global team