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CHIV AssayConfident HIV screening to support earlier detection, efficient workflows, and effective patient care

Clinical laboratory testing remains essential across the HIV-care continuum, helping clinicians support prevention, diagnosis, counseling, treatment decisions, and long-term patient management. Aligned with current testing guidelines (CDC, WHO)1,2, the Siemens Healthineers 4th generation HIV Ag/Ab Combo (CHIV) assay delivers advanced and reliable HIV testing screening with clinical confidence, operational efficiency, and platform flexibility needed in today’s healthcare environment to help optimize care outcomes.

Benefits

The Siemens Healthineers CHIV assay sets a standard for clinical excellence, infectious disease testing consolidation, and consistent results across Atellica IM and Atellica CI systems—helping laboratories standardize HIV screening while supporting confident clinical decisions and efficient operations.

1st generation HIV assay – Detects HIV-1 Antibody (IgG) 
2nd generation HIV assay – Detects HIV-1& HIV-2 Antibodies (IgG) 
3rd generation HIV assay – Detects HIV-1 & HIV-2 Antibodies (IgG, IGM) 
4th generation HIV combo assay – Detects HIV Antigen (p24), HIV-1 & HIV-2 Antibodies (IgG, IGM)

The Siemens Healthineers CHIV assay enables reliable and accurate HIV screening to aid timely clinical decision-making, while integrating seamlessly into Atellica system workflows—without compromising STAT assay turnaround time or routine throughput. Built for consistency and robustness, the assay enables laboratories to achieve precise, reproducible results, support compliance, and uphold the high clinical standards of a 4th generation HIV Ag/Ab combo assay 3,4,5.

In a higher-risk population study, the Siemens Healthineers 4th generation CHIV assay demonstrated stronger performance against other commercially available 4th generation Ag/Ab combo assays, detected all early seroconversion samples, and produced fewer false-reactive results among samples with no evidence of HIV infection6.

A – Overall Sensitivity
B – Specificity, HIV-1 low risk population
C – Specificity, HIV-2 high risk population
D – Specificity, HIV-2 high risk endemic population

The Siemens Healthineers CHIV assay delivers strong clinical sensitivity and specificity to support earlier HIV detection through combined p24 antigen and HIV-1/HIV-2 antibody identification5,9. The assay provides reliable performance across diverse HIV subtypes and target populations, helping laboratories reduce reflex testing that can delay treatment, supporting timely counseling, intervention, and care planning with confidence in results.

1. Reduction in technicians to manage all testing, from 5.5 FTE to 3 FTE
2. Reduction in average turnaround times for HIV serology testing, from test order to verified result
3. Percentage of serology results returned in under 2 hours, up from 6%, from test order to verified result

Consolidate HIV testing alongside our hepatitis, syphilis, ToRCH, and a growing infectious disease assay menu—with a broad range of routine and STAT testing on the Atellica Solution, without compromising turnaround time7.

At the University Hospital of Grenoble, France, part of the infectious serology workload was consolidated onto a single automated platform alongside STAT assays, routine chemistry, and immunoassay testing. By unifying these workflows, the lab reduced serology turnaround times without impacting STAT performance8.

This high-capacity, fully automated solution is designed to enhance productivity, reduce send-outs, simplify workflow, and support timely, confident clinical decisions.

1st generation HIV assay – Detects HIV-1 Antibody (IgG) 
2nd generation HIV assay – Detects HIV-1& HIV-2 Antibodies (IgG) 
3rd generation HIV assay – Detects HIV-1 & HIV-2 Antibodies (IgG, IGM) 
4th generation HIV combo assay – Detects HIV Antigen (p24), HIV-1 & HIV-2 Antibodies (IgG, IGM)

The Siemens Healthineers CHIV assay enables reliable and accurate HIV screening to aid timely clinical decision-making, while integrating seamlessly into Atellica system workflows—without compromising STAT assay turnaround time or routine throughput. Built for consistency and robustness, the assay enables laboratories to achieve precise, reproducible results, support compliance, and uphold the high clinical standards of a 4th generation HIV Ag/Ab combo assay 3,4,5.

In a higher-risk population study, the Siemens Healthineers 4th generation CHIV assay demonstrated stronger performance against other commercially available 4th generation Ag/Ab combo assays, detected all early seroconversion samples, and produced fewer false-reactive results among samples with no evidence of HIV infection6.

 

Confidence when standardizing HIV screening

Laboratories can expect highly consistent, robust CHIV assay performance across Siemens Healthineers analyzers, with approximately 100% agreement demonstrated across more than 3,300 clinical samples—including early infection, high-risk populations, pediatric patients, and multiple HIV genotypes.

Atellica IM, Atellica CI and ADVIA Centaur analyzers use the same assay formulation, enabling laboratories to confidently transition, scale, or standardize HIV testing across hub and spoke networks while maintaining consistent results.9

Category

Overall Agreement Across Analyzers

Clinical Relevance

Healthy adults

99.9%

Routine HIV testing

Routine HIV testing

100%

Maternal and prenatal testing

High-risk populations (H, IIDU, MSM, MT, Renal dialysis, STD)

99.8%

Early detection in higher prevalence settings

Pediatric patients

100%

Broad age-range applicability

HIV-1, HIV-1 Group O, HIV-2

100%

Broad genotype coverage

p24 antigen (native & contrived)

100%

Early infection detection

Technical Details

Assay Specifications

System Availability

Assay Name

Atellica IM HIV Ag/Ab Combo (CHIV)

Assay Type

4th generation HIV antigen/antibody combined immunoassay

Assay Method

2-step sandwich immunoassay5

Sample Type

Serum or plasma (100 µL)5

Detection Targets

HIV-1 p24 antigen, Antibodies to HIV-1, including group O, Antibodies to HIV-2

Atellica IM

Consolidate HIV testing alongside other infectious disease assays, helping laboratories support timely clinical decisions and efficient infectious disease workflows.

Atellica CI 

Drive confidence when standardizing HIV screening with a single chemistry and immunoassay analyzer designed for hub and spoke environments.

Evidence

“Running infectious diseases assays on the same systems we use for urgent biological analysis, such as troponin, has shown no impact to turnaround times… Siemens Healthineers' ability to provide a complete solution has delivered significant improvement in the time it takes to deliver results.”
Dr. Carole Chirica
Dr. Carole Chirica
Leading medical biologist, University Hospital of Grenoble, France
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​1
Centers for Disease Control and Prevention. Available from: https://stacks.cdc.gov/view/cdc/50872. Accessed May 2026.
​2
World Health Organization. Available from: https://www.who.int/publications/i/item/9789240096394. Accessed May 2026.
3
Delaney K, et al. The Evolution of HIV Testing Continues. Sexually Transmitted Diseases. 2017;44(12):747-749.
4
Stone M, et al. Comparison of Detection Limits of Fourth- and Fifth-Generation Combination HIV Antigen-Antibody, p24 Antigen, and Viral Load Assays on Diverse HIV Isolates. J Clin Microbiol. 2018;56:e02045-17.
5
Data on file. Atellica IM and Atellica CI CHIV IFU.
6
Krajden M, et al. Pooled nucleic acid testing increases the diagnostic yield of acute HIV infections in a high-risk population compared to 3rd and 4th generation HIV enzyme immunoassays. J Clin Virol. 2014 Sep;61(1):132-7.
7
Real World Assessment of the Impact of Infectious Disease Assays on Workflow Capabilities of Atellica IM Analyzer. White Paper QR700010799. 07-2024.
8
CLS 85 Percent Faster ID Turnaround on the Same System Without Slowing STATs at University Hospital of Grenoble. QR700040408.05-2026
9
Ricci B, Anostario M, Fonstad R, Bonito A, Healy B, Riverso N, Birmingham N, Kiefer D, El-Khoury JM, Mohammad AA. Siemens Healthineers Cross-Platform Verification: Analytical and Clinical Analysis of HIV Antigen/Antibody Combo Assay Across ADVIA Centaur and Atellica Analyzers. Journal of Clinical Virology Plus. 2026.
10
Centers for Disease Control and Prevention. Viral Hepatitis Among People with HIV. Available from: https://www.cdc.gov/hepatitis/hcp/populations-settings/hiv.html. Accessed May 2026.
11
Effect of syphilis infection on HIV acquisition: a systematic review and meta-analysis. Available from: https://pmc.ncbi.nlm.nih.gov/articles/PMC8543214/. Accessed May 2026.
12
HIV.gov. Syphilis and People Living with HIV. Available from: https://www.hiv.gov/hiv-basics/staying-in-hiv-care/other-related-health-issues/syphilis. Accessed May 2026.
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