One Test, Three Viruses: Advancing HIV Screening with HBV/HCV/HIV NAT

According to the latest data from UNAIDS, about 41 million people were living with HIV worldwide by the end of 2025, with roughly 1.2 million new infections and some 570,000 HIV-related deaths every year ^[1]. The WHO Global Health Sector Strategies on HIV, Viral Hepatitis and Sexually Transmitted Infections, 2022–2030 explicitly call for eliminating viral hepatitis and AIDS as public health threats by 2030, setting the “95-95-95” targets: by 2030, 95% of people living with HIV should know their status, 95% of those diagnosed should be on treatment, and 95% of those treated should be virally suppressed ^[2].
China’s HIV situation is also far from optimistic: by the end of 2025, the cumulative number of reported people living with HIV/AIDS nationwide was about 1.41 million — 775,000 with HIV infection and 635,000 with AIDS — while cumulative reported deaths exceeded 520,000. In 2025, 87,881 new cases were reported, of which heterosexual transmission accounted for 72.8% and same-sex transmission 25.7% ^[3]. To meet this severe challenge, the Plan for AIDS Containment, Prevention and Treatment in China (2024–2030) further calls for more than 95% of people living with HIV to be diagnosed and aware of their infection status by 2030 ^[4]. At present, however, China’s HIV case-finding rate is only 84% — still a gap from the 95% target — and the proportion of late HIV diagnosis is relatively high, at 38.7%.

Against this backdrop, expanding testing and optimizing diagnostic strategies has become one of the core tasks of AIDS prevention and control in China. Since its first release in 1997, the National Guideline for HIV Testing has undergone four systematic revisions, continuously introducing new technologies and optimizing testing pathways. The latest revision — the National Guideline for HIV Testing (2025 Revision) — incorporates NAT into the screening algorithm for the first time. Where an individual, within the past 6 months, has an epidemiological history of HIV exposure, presents with acute or very late-stage clinical symptoms of HIV infection, has used pre-/post-exposure prophylaxis irregularly, or has special conditions such as immunosuppression or immunodeficiency, and the HIV antigen/antibody (Ag/Ab) test or HIV antibody test is non-reactive, HIV-1 NAT screening can be performed to indicate whether an acute infection is present within the window period of antibody or antigen testing. Among key populations with HIV, HBV and HCV co-infection, and among special populations attending medical institutions (e.g., people with immune deficiency), combined NAT for the three pathogens can rapidly and accurately identify unusual infections that are difficult to detect and diagnose by antibody testing alone — effectively integrating testing resources, helping infected individuals fully understand their infection status, and reducing the potential risk of iatrogenic transmission ^[5].

2.1.4  Screening algorithm using the HIV-1 nucleic acid test

If an individual, within the past 6 months, has an epidemiological history of HIV exposure, presents with acute or very late-stage clinical symptoms of HIV infection, has used pre-/post-exposure prophylaxis irregularly, or has special conditions such as immunosuppression or immunodeficiency, and the HIV Ag/Ab test or HIV antibody test is non-reactive, HIV-1 NAT screening may be performed to indicate whether an acute infection exists within the window period of antibody or antigen testing. If the HIV-1 NAT screening test is non-reactive, the result is reported as “HIV-1 NAT negative”; if reactive, it is reported as “HIV-1 NAT indeterminate”, a new blood sample must be collected, and an HIV-1 supplementary NAT is required to confirm infection.

Figure 4-4.  Screening algorithm using the HIV-1 nucleic acid test (National Guideline for HIV Testing, 2025 Revision)

6.3  Combined NAT for HIV and viral hepatitis

Combined NAT for AIDS and viral hepatitis refers to methods that detect, in a single assay, the nucleic acids of multiple pathogens that share similar transmission routes and affected populations — HIV together with hepatitis B virus (HBV) and hepatitis C virus (HCV); such combined assays are currently mainly qualitative. In blood-station screening of donated blood, combined HIV/HBV/HCV NAT has been widely validated and adopted; used together with antigen/antibody-based immunoassays, it effectively reduces missed detections of HIV, HBV and HCV infection and safeguards the safety of clinical blood transfusion. In recent years, studies have also explored applying combined NAT for the three pathogens among key populations co-infected with HIV, HBV and HCV, and among special populations attending medical institutions (e.g., people with immune deficiency), in order to rapidly and accurately identify unusual infections that antibody testing alone can hardly detect or diagnose — effectively integrating testing resources, helping infected individuals fully understand their infection status, and reducing potential iatrogenic transmission risks.

In August 2026, at the Symposium on Enhancing Multi-Disease Prevention and Control Capacity for Key Infectious Diseases — hosted by the Chinese Association of STD & AIDS Prevention and Control and co-organized by the Shandong Provincial Association of Public Health and AIDS Prevention and Control (“Shandong AIDS Association”) — Dr. Jin Cong, Director of the Reference Laboratory at the National Center for STD/AIDS Prevention and Control, China CDC, gave a professional interpretation of the key points of the National Guideline for HIV Testing (2025 Revision). She made clear that where an individual, within the past 6 months, has an epidemiological history of HIV exposure, presents with acute or very late-stage clinical symptoms of HIV infection, has used pre-/post-exposure prophylaxis irregularly, or has special conditions such as immunosuppression or immunodeficiency, HIV-1 NAT screening may be performed to indicate whether an acute infection exists within the window period of antibody or antigen testing — and that, depending on turnaround-time requirements, the Ag/Ab test may be performed concurrently with the nucleic acid test, further broadening the application of NAT within the HIV screening algorithm.

Nucleic Acid Test Kit for HBV, HCV, HIV (Type 1+2)  (Real-time PCR) * CE List A certified

 

	Limit of detection	Genotype coverage
HBV	2.41 IU/ml	HBV genotypes A, B, C, D, E, F, G, H
HCV	12.38 IU/ml	HCV genotypes 1, 2, 3, 4, 5, 6
HIV-1	31.68 IU/ml	HIV-1 Group M, N, O
HIV-2	48.34 IU/ml	HIV-2 Subtypes A/B

• Detection principle: single tube, multiple fluorescence PCR technology, can detect four items
• DNA/RNA Extraction: lysis at room temperature
• Extraction technology: magnetic bead method
• Sample type: plasma, serum
• Nucleic acid does not require elution and is amplififiedwith magnetic beads

 
  References

• Global HIV & AIDS statistics: Fact sheet [EB/OL]. (2026-07-27) [2026-09-18]. https://www.unaids.org/en/resources/fact-sheet.
• World Health Organization. Global health sector strategies on HIV, viral hepatitis and sexually transmitted infections for the period 2022–2030 [R/OL]. Geneva: WHO. (2022) [2026-09-18]. https://www.who.int/teams/global-hiv-hepatitis-and-stis-programmes/strategies/global-health-sector-strategies.
• National Center for STD/AIDS Prevention and Control, China CDC. Epidemiology of HIV/AIDS and STIs in China, December 2025 [J]. Chinese Journal of AIDS & STD, 2026, 3: 253. DOI: 10.13419/j.cnki.aids.2026.03.01.
• General Office of the State Council of the PRC. Plan for AIDS Containment, Prevention and Treatment in China (2024–2030) [R/OL]. (2024-12-06) [2026-09-18]. https://www.gov.cn/zhengce/content/202412/content_6992032.htm.
• Chinese Center for Disease Control and Prevention. National Guideline for HIV Testing (2025 Revision) [S]. Beijing: China CDC, 2025.