It is estimated that by the end of 2011, the number of people living with HIV in China was about 780,000 . The National HIV/AIDs report showed that, men who have sex with men (MSM) and female sex workers FSW recorded a 5% and 6% (median) estimated prevalence respectively in 2009 which far exceeds the general populations’ prevalence of 0.05% [2, 3]. Hence, MSM and FSW are categorized as ‘populations at highest risk’ of infection for HIV in China. Report at the end of October 2012 showed that cumulatively, the number of reported HIV/AIDS cases was 492, 191, with 383,285 people living with HIV/AIDS . This means that over half of people living with HIV/AIDS do not know that they are infected. Studies showed that about 33.2% of MSM and 42% of FSW have never been tested [3, 5] and 86.1% of infected MSM are unaware of their infection status [5–7]. Thus, testing rate among both MSM and FSW is low and this means that over half of people living with HIV/AIDS do not know that they are infected [5–9].
Voluntary counseling and testing (VCT) has been an important tool employed by WHO and other health organizations worldwide to identify new cases and implement treatment as prevention strategies . The imperative of scaling up HIV testing in China was recognized as an important strategy for identifying unknown positives and preventing onward transmission of HIV [11, 12]. Free HIV testing has been made available, and expanded from 365 counties in 15 provinces in 2002 to over 2300 counties, with 3037 sites, in all provinces by 2006 [1, 4, 11]. However, the biological, social, economic, political, and ethical concerns surrounding HIV surveillance, access to care and prevention still remains complex [1, 2, 13].
Currently, enzyme-linked immunosorbent assay (ELISA) combined with western-blot and rapid blood testing are the major HIV antibody testing methods employed in HIV testing in most countries including China [14–16]. Though ELISA is the ‘gold-standard’ HIV testing method for screening, which is recognized traditionally, it is not without disadvantages [17–19]. For example, it cannot be used in point-of care since it requires ELISA equipment and professional staff for its use, waiting time for results has been reported to be too long and expensive hence discouraging users . Also, the use of needles and sharp objects with their associated pains to obtain the needed blood sample deter many people from using it. For FSW and MSM, providing an alternative testing method eliminates the issue of facing professionals in front of whom they might have to answer questions on their number of sexual partners and their sexual orientation which most of them find uncomfortable [2, 3, 5–9]. Notwithstanding there is an urgent need for acceptable and feasible testing methods among MSM, FSW and VCT clients in order to scale up HIV testing.
Rapid oral fluid based testing method has already been approved and is in use in most HIV testing institutes worldwide [7, 21–25]. The testing kits and testing method have further been found to be accurate, much safer and easier to use and therefore recommended for adoption and use in the developing countries due to its simplicity, versatility and, feasibility that enables easier implementation and use even in rural areas and private health institutions [22, 23]. Also, incorporation of oral HIV tests could form part of a multi-pronged prevention strategy in transforming the trajectory of the HIV epidemic in China and possibly the world at large [24, 25]. A study conducted in Seattle indicated that clients are more likely to accept HIV testing using this method instead of standard blood testing because it is less intrusive and painless .
Although four testing kits have been approved as of the end of 2011;  “ Sidaizhiyu Oral Fluid HIV ½ Antibody Diagnostic Kit” (Wondfo Biomedical Co., Ltd, 2011), “Union Oral Mucosal Transudate HIV-1/2 Antibody Detection Kit “(Chengdu Union Bio-technology Ltd., 2011), “Aware HIV-1/2 OMT” (Beijing Marrbio Ltd, 2008) and “HIV 1/2 antibody Dot ELISA rapid test” (Beijing Wantai Biological Pharmacy Enterprise Co., Ltd., 2011 ),  rapid oral testing is however not been widely used and no data exist to assess the uptake of oral testing and how accurate these kits are in real world settings in China. Hence this studies to ascertain the feasibility of up scaling its usage in China.