Skip to main content
Download PDF

A comparative analysis of the different HIV testing techniques used in Zambia: data from a clinical performance study

BMC Research Notes volume 18, Article number: 131 (2025) Cite this article

Abstract

Background

Approximately 40 million people globally are living with HIV (PLWH) and more than 50% of these PLWH reside in Eastern and Southern Africa. Zambia has an adult HIV-1 prevalence (ages 15–49) of 11.1 [10.5–11.6] %, among the highest in the world (UNAIDS, 2021). In 2020, 1.5 million people were estimated living with HIV-1 in Zambia. Despite the success of many HIV preventative strategies, and worldwide sensitization to know one’s status, there remains a substantial number of people with HIV who are unaware of their infection and are still infecting others. Globally, about 20% of HIV infections are due to transmissions from recently infected individuals. As Zambia’s adult HIV prevalence is about 11.1%, if 3rd generation RDTs are used for first time HIV testing, all the people tested that are within the acute period will be given a false negative result. Hence the need to develop better first line HIV testing techniques.

Method

A quantitative descriptive approach was used to analyze samples of 2564 participants, between the ages of 15 to 95 years from two Lusaka sites. The 2564 participants were subjected to OraQuick ADVANCE Rapid HIV-1/2 Antibody Test and Abbot Determine™ HIV-1/2 antibody test, if Reactive on either test, the result was confirmed on Uni-Gold™ Recombigen® HIV-1/2 rapid test as a confirmatory RDT. An EDTA tube of blood for each of the 2564 participants was collected and sent to the central laboratory for further testing on fourth generation Abbot ARCHITECT HIV Ag/Ab Combo and then any discrepancies were confirmed on Genscreen™ ULTRA HIV Ag-Ab. Using a systematic analysis technique, quantitative methods were applied to evaluate different variables and compare them against each other to find relationships. The data were cleaned using Microsoft excel and were analyzed using SPSS version 25.0.

Results

The Abbot ARCHITECT HIV Ag/Ab Combo fourth generation assay was used as the gold standard, of the total 2564 tested 267 (10.4%) were reactive tests and 2297(89.6%) non-reactive. OraQuick ADVANCE Rapid HIV-1/2 test detected 245(9.6%) reactive tests and 2319 (90.4%) non-reactive, Abbot Determine™ HIV-1/2 test detected 249(9.7%) true reactive tests and 2315 (90.3%) non-reactive, all reactive tests on the first two RDTs were confirmed on Uni-Gold™ Recombigen® HIV-1/2 rapid test which detected 247 (9.6%) reactive and 2317 (90.4%) non-reactive. These results show that compared to the gold standard the 3 RDTs missed more than 18 (6.7% of the total 267) reactive results. This means that in every 15 tests done, 1 result is a false negative.

Conclusion

Third generation RDTs were unable to detect a good number of acute positive cases and are therefore unreliable. There is therefore need for the use 4th generation Rapid test to capture the positive cases currently being missed out.

Peer Review reports

Introduction

According to WHO global HIV summary report, by the end of 2019 there was a total of 38 million people living with HIV, 2.5 million new infections and 1.7 million deaths each year, emphasizing that the global response would have to be sustained for at least several decades in order to curb the HIV epidemic [1]. Despite all the strategies put in place to help end the HIV/AIDS epidemic, there still remains a substantial number of people with HIV who are unaware of their infection and are still infecting others [2]. The only way to determine a person’s HIV status is to have an HIV test. Globally about 20% of HIV infections are due to transmissions from recently infected individuals [3]. The World Health Organization recommends two sequential rapid diagnostic tests (RDTs) for HIV diagnosis, however third generation RDTs detect only HIV antibodies and may miss up to 75% of early HIV infections [4, 6,7,8,9].

Zambia has an adult HIV prevalence of 11.1% meaning failure to diagnose HIV in the weeks after an individual has acquired infection negatively impacts the epidemic control by increasing the likelihood of onward transmission [3]. The Zambia Public Health Service HIV testing algorithm has not changed substantially in the past decades, despite the introduction and wide use of new technology. It is very necessary to revise testing guidelines to more accurately reflect new technology and associated challenges [10]. The Zambian HIV test algorithm uses RDTs that only detect antibodies, which means that most acute infections are missed in the first line tests and may be falsely reported as negative. The national RDT algorithm in Zambia consists of a screening test (Determine® HIV 1/2) followed by confirmation of reactive specimens with a second rapid test (Uni-gold HIV 1/2). To test respondents via RDT, a blood sample is collected directly from a finger prick [11].

According to the CDC, guidelines for HIV testing continue to evolve with changes in testing technology and methods to reach persons who can benefit from these services. The ministry of health Zambia recommends the testing algorithm shown in Fig. 1 below,

Fig. 1
figure 1

Zambia national algorithm for HIV testing using rapid tests

Full size image

Aim

The main aim of the study was to investigate the effectiveness of different HIV testing strategies used in Zambia. Early detection of HIV means early identification of people living with HIV, who are immediately linked to care and antiretroviral therapy. This decreases transmission of the virus, which reduces HIV new infection rates.

Methods

Study design and setting

The study used quantitative methods by comparing different variables of the five different HIV tests using statistical methods. The comparison between these diagnostic tests formed the foundation of this comparative evaluation of HIV testing techniques.

The study analyzed data collected during the STAR (Self testing Africa) study that took place between July 2016 and June 2017. The study data was collected from 2564 participants of M’tendere, Lusaka district and of Kanakantapa, Chongwe district of Zambia. 2574 participants took part in the study, among these 10 did not submit a sample for further analysis at the Lab and hence were excluded. The study population comprised of all individuals screened from the two different sites in Lusaka that had an HIV test on the 3 point of care tests and agreed to have 1 tube of blood sample collected and sent to the Laboratory for further tests. This population was selected because of the proximity to the research Laboratory and because it included both rural and urban population.

Samples were collected by trained personnel following participant informed consent and complete assessment. Samples analyzed included oral mucosa transudate using the OraQuick® HIV Self-Test (Oraquick), fingerprick blood was collected and tested on Alere Determine™ HIV1/2 (Determine), if positive on Determine it was then confirmed on UnigoldTMHIV1/2 (Unigold) test following the Zambian national testing algorithm. The results were provided to participants, and data stored in electronic devices, all participants with reactive test results were referred for HIV care and treatment at local health facility [12].

In addition to the three rapid tests performed at Point of Care, 10 mls whole blood was collected from each participant by trained personnel and sent to the Laboratory for further testing on fourth generation assays. At the Laboratory, the samples were double-span and plasma was separated and tested on the Abbot Architect HIV Ag/Ab Combo fourth generation instrument as the gold standard for the rapid tests. (12, 13–14) If result was reactive, it was then run on manual ELISA Genscreen™ ULTRA HIV Ag-Ab to confirm positivity.

Specificity and Sensitivity of the five different HIV testing strategies were measured by calculating the percentage of positive results yielded by these tests among all samples that tested positive for HIV based on detection of HIV positive results of the Abbot Architect test [15]. Rapid test positivity was calculated by comparing the characteristics of HIV-positive and HIV-negative results. The Results were reported in accordance with the Standards for Reporting of Diagnostic Accuracy: Sensitivity, specificity, positive and negative predictive values at 95% confidence intervals using SPSS version 25.0.

Inclusion and exclusion criteria

The study only included samples of participants who gave informed consent to participate in the STAR study [12] and who were tested on all 5 of the HIV test types being investigated. 2574 participants were screened but 10 did not give consent to giving a sample for laboratory testing. The 10 participants who did not give consent or did not give a third sample for Laboratory testing were excluded from the study.

Statistical analysis

Data was analyzed using Microsoft Excel spreadsheet for broader thematic analysis and SPSS version 25.0. Exact confidence intervals (CIs) were calculated according to the binomial distribution. Variables were summarized as frequencies and percentages with significant level at 0.05 (95%CI). Sensitivity, specificity, positive and negative predictive values were determined using cross-tables and standard formulas of the third generation HIV RDTs, the Abbot fourth generation immunoassay was used as the gold standard. Data from the STAR-Study were entered into a Microsoft excel sheet, checked for duplication and error and then subsequently exported to SPSS version 25 for analysis.

Study population

Of the total 2574 participants screened, 10 did not consent to further Laboratory testing, hence the total study population included 2564 males and females from Mtendere and Kanakantampa districts between the ages of 15 to 95 years.

Results

The study examined specimen of 2564 participants, which were tested on the 5 different HIV tests being investigated. The rapid diagnostic laboratory tests were evaluated based on a comparison test method. The investigation evaluated the test accuracy of five diagnostic assays for the identification of HIV based on sensitivity and specificity measures. Among the 2564 samples analyzed, 1043 (40.7%) were male and 1521 (59.3%) female. The 2564 samples were from participants of a wide range of ages from the age of 15 to as old as 95 years as show in Table 1. All participants below 18 years agreed to participate with guided parental consent.

The study included participants from two sites: Mtendere, representing the urban population and Kanakantampa the rural population. About 1955 (76.2%) participants were from Mtendere and 609 (23.8%) participants from Kanakantampa. There were more female (63.2%) than male (36.8%) participants in Mtenedere took part in the study, while in Kanakantampa more male (53.2%) participants took part in the study compared to females (46.8%). In both sites the highest participating ages range from 18 to 45 years of Age.

The table below compares gender and Age of participants to HIV test results of the Abbot, used as a reference. As expected, female participants (68.9%) had a higher positivity rate compared to male participants (31.1%). The age range with the highest positive results was 26 to 35 (38.9%) years.

Table 1 Gender and age categories of participants compared to the gold standard HIV test results
Full size table

The samples sent to the lab were processed and tested on the Abbot Architect and then all that were positive on Abbot Architect were confirmed using the Genscreen Biorad ELISA test. Table 2 shows a breakdown of how many tests from each Assay were reactive, non-reactive and not tested.

Table 2 Comparison of the results of OraQuick, Determine and UniGold to the gold standard
Full size table

Of the 2564 samples tested on the Abbot Architect analyzer, 2297 (89.6%) were negative and 267 (10.4%) were positive as shown in the table. When compared to the gold standard test, OraQuick ADVANCE Rapid HIV-1/2 test detected 245(9.6%) reactive tests and 2319 (90.4%) non-reactive (22 reactive tests were missed), Abbot Determine™ HIV-1/2 test detected 249(9.7%) true reactive tests and 2315 (90.3%) non-reactive (it missed about 18 reactive tests). About 253 tests were reactive on both OraQuick and Determine, these reactive tests were confirmed on Uni-Gold™ Recombigen® HIV-1/2 rapid test which detected 247 (9.6%) reactive tests and 6 (0.3%) non-reactive, (compared to Abbot Architect, this test missed 20 reactive tests).

As shown in Table 2 above, the tests that were Non-Reactive on both OraQuick and ABBOT were 2297(89.6%), 245(9.6%) were Reactive on both tests. 22(0.8%) tests were Reactive on ABBOT and non-reactive on OraQuick, meaning that ABBOT picked up 22(0.8%) more positive tests that OraQuick tested as non-reactive. 4(0.2%) tests were Non-reactive on Oraquick but reactive on Determine and Unigold.

The confirmatory test for both OraQuick and Determine rapid tests, therefore only the tests reactive on Determine were tested on UniGold. Of the 253(9.9%) tests tested on UniGold, 2(0.1%) were Non-Reactive on Unigold but reactive on Determine and Abbot Architect.

Fig. 2
figure 2

summary of test results of the 3 RDTs

Full size image

Referring to Fig. 2 above, 2293(89.4%) tests were non-reactive on both determine and Abbot Architect. 249 (9.7%) tests were reactive on both Abbot Architect and Determine. 18(0.7%) were Reactive on Abbot Architect and Non-reactive on Determine, showing that Abbot Architect has a higher sensitivity compared to Determine [16]. There were 4 tests that were reactive on Determine and non-reactive on Abbot Architect the reference test, showing a 0.2% low specificity rate of Determine.

The Abbot Architect as the reference standard, had 2297(89.6%) negative results and 267(10.4%) positive results, when compared to the other test results. When OraQuick results were compared to the gold standard, it was observed that of the 267 reactive results, OraQuick only detected 245 (91.8%) positive results and missed 22 (8.2%). When compared to Abbot Architect results, Determine 249 (93.3%) reactive and 18 tests negative on Determine but positive on ABBOT. The 249 Reactive results on Determine were confirmed on the UniGold test kit, of the 249 tested on UniGold, 247 were reactive and 2 gave false positive results. Compared to Abbot Architect results, UniGold was Reactive on 247 (92.5%) tests and gave 20 (7.5%) non-reactive results.

Table 3 Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of the 4 assays
Full size table

As shown in Table 3, OraQuick ADVANCE® Rapid HIV-1/2, Alere Determine HIV-1/2 and Uni-Gold Ultra HIV, at 95% CI had Sensitivities of: 91.8%, 93.3% and 92.5% respectively, of which when compared to the sensitivities reported by the manufacturers is quite low despite manufacturers reports of high sensitivity and specificity for these RDTs [17].

The specificities of OraQuick ADVANCE® Rapid HIV-1/2 and Uni-Gold HIV were the same (100.0%; 95% CI: 98.8–100.0) but slightly different from Alere Determine HIV-1/2 (99.8%). Negative predictive values (at 95% CIs) were 99.1, 99.2 and 99.1 for OraQuick ADVANCE® Rapid HIV-1/2, Alere Determine HIV-1/2, and Uni-Gold Ultra HIV respectively similar to Kashoshi study findings [16].

Discussion

The study established that the three-3rd generation HIV RDTs used at Point of Care for HIV testing though quite sensitive, still fail to detect a significant number of acute infections. About 1 in every 10 people tested using 3rd generation RDTs goes home with false negative results [18, 19]. In resource-limited or point-of-care settings, rapid diagnostic tests (RDTs), that aim to simultaneously detect HIV antibodies and p24 capsid (p24CA) antigen with high sensitivity, can pose important alternatives to screen for early infections [20, 21].

Given the brief window of acute HIV infection, the acute HIV prevalence in a population is very low at any given point in time, even among relatively high-risk groups. Consequently, a test must have exceptional performance characteristics to be useful, especially without additional confirmatory testing [19, 22]. The Determine®HIV-1/2 Ag/Ab Combo rapid test has been marketed as such a test, because it is relatively inexpensive and can be administered at the point of care [19, 23]. Although the performance characteristics of the Determine®HIV-1/2 Ag/Ab Combo rapid test were insufficient for use in clinical setting, field evaluation in other settings may be warranted to assess whether the test performs better. The Determine®HIV-1/2 Ag/Ab Combo rapid test has been previously evaluated with stored serum or plasma specimens [24, 25]. Despite this, HIV RDTs have some limitations since they cannot identify persons who are within the window period of an acute HIV infection because these individuals have not yet developed HIV-specific antibodies [26, 27]. Such individuals are highly infectious due to concurrent high plasma as well as vaginal and semen HIV-1 viral load [3, 28].

Conclusion

This study went out to establish the possibility of unacceptably low sensitivities of the RDTs Alere Determine HIV-1/2 and Uni-Gold HIV, using blood and, OraQuick ADVANCE® Rapid HIV-1/2 using mouth swabs in Zambia. This raises serious concerns about rapid test dependability and calls for stringent control measures as well as the need for 4th generation Ag-Ab RDTs and a cross-evaluation of all Rapid diagnostic tests results by a laboratory-based antigen testing, whenever feasible.

An alternative HIV testing algorithm, which includes a fourth-generation Determine® HIV-1/2 Ag/Ab Combo rapid test with a better sensitivity and specificity, is necessary [19, 25]. Developing and introducing a point-of-care test with adequate sensitivity and specificity for acute HIV detection is extremely challenging but very feasible. The Determine®HIV-1/2 Ag/Ab Combo rapid test was designed to provide a marginal reduction in the HIV window period by testing for both Antibodies and Antigens at point of care settings [13, 14, 19, 21, 24, 26,27,28,29,30].

Limitations

The data used in this study was secondary, and collected from another study, access to the data was not easy.

Data availability

All data generated or analyzed during this study are included in this published Article supporting the article. For other data, these may be requested through the corresponding Author.

Abbreviations

Ab:

Antibody

Ag:

Antigen

AIDS:

Acquired Immuno-Deficiency Syndrome

ART:

Anti-Retroviral Therapy

CI:

Confidence Interval

CDC:

Centers for Disease Control and Prevention

EIA:

Enzyme Immuno-Assay

ELISA:

Enzyme Linked Immuno-Sorbent Assay

IgG:

Immunoglobulin G

IgM:

Immunoglobulin M

HIV:

Human Immuno-deficiency Virus

HTC:

HIV Testing and Counselling

MDG:

Millennium Development Goal

MoH:

Ministry of Health

NCHS:

National Center for Health Statistics

NGO:

Non-Governmental Organization

NPV:

Negative Predictive Value

POC:

Point of Care

PPV:

Positive Predictive Value

RDT:

Rapid Diagnostic Test

SD:

Standard Deviation

SDG:

Sustainable Developmental Goals

STAR:

Self Testing Africa Study

UNAIDS:

United Nations Program on HIV/AIDS

WHO:

World Health Organization

ZDHS:

Zambia Demographic and Health Survey

References

  1. Piot P, Quinn TC. (2013) Response to the AIDS Pandemic - A Global Health Model, New England Journal of Medicine June 6, 2013 368(23):2210. https://www.nejm.org/doi/full/10.1056/NEJMra1201533

  2. World Health Organization. (2018) Consolidated Guidelines on HIV Testing Services http://apps.who.int/iris/bitstream/10665/ Accessed: 28 April 2021.

  3. Cohen SM, Cynthia L, Gay MP, Busch FM, Hecht. The detection of Acute HIV infection. J Infect Dis. 2010;202:270–S277. https://doiorg.publicaciones.saludcastillayleon.es/10.1086/655651.

    Article  Google Scholar 

  4. World Health Organization. (2014) HIV/AIDS. Global situation and trends. http://www.who.int/gho/hiv/en/ accessed on 13th March 2021.

  5. Patel P, Bennett B, Sullivan T, Parker MM, Heffelfinger JD, Sullivan PS, CDC AHI Study Group. Rapid HIV screening: missed opportunities for HIV diagnosis and prevention. J Clin Virology: Official Publication Pan Am Soc Clin Virol. 2012;54(1):42–7. https://doiorg.publicaciones.saludcastillayleon.es/10.1016/j.jcv.2012.01.022.

    Article  Google Scholar 

  6. Greg Stewart MEO, Bajzik O, Ferret M, Bentsen C, Kathleen Shriver M. Performance comparison of the 4th generation Bio-rad Laboratories GS HIV Combo Ag/Ab EIA on the EVOLIS™ automated system versus Abbott ARCHITECT HIV Ag/Ab combo, Ortho Anti-HIV 1 + 2 EIA on Vitros ECi and Siemens HIV-1/O/2 enhanced on Advia Centaur. J Clin Virol Volume. 2013;58. https://doiorg.publicaciones.saludcastillayleon.es/10.1016/j.jcv.2013.08.009. Supplement 1, Pages e79-e84.

  7. Bentsen C, McLaughlin L, Mitchell E, Ferrera C, Liska S, Myers R, Peel S, Swenson P, Gadelle S, Shriver MK. Performance evaluation of the Bio-rad Laboratories GS HIV Combo Ag/Ab EIA, a 4th generation HIV assay for the simultaneous detection of HIV p24 antigen and antibodies to HIV-1 (groups M and O) and HIV-2 in human serum or plasma. J Clin Virol. 2011;52(Suppl 1):57–61.

    Article  Google Scholar 

  8. Chavez P, Wesolowski L, Patel P, Delaney K, Owen SM. Evaluation of the performance of the Abbott ARCHITECT HIV Ag/Ab combo assay. J Clin Virol. 2011;52(Suppl 1):51–5.

    Article  Google Scholar 

  9. Alere Limited. (2014). Alere Determine® HIV-1/2; 20DetermineW%20HIV%20eng.pdf, Alere Determine HIV 1/2 Ag/Ab Combo, package insert. Waltham, MA, USA; 2014.

  10. Daskalakis D. HIV diagnostic testing: evolving technology and testing strategies. Top Antiviral Med. 2011;19(1):18–22.

    Google Scholar 

  11. Zambia Demographic and Health Survey. (2018). HIV/AIDS Related Knowledge, Attitudes and Behaviour, Rockville, Maryland, USA: Zambia Statistics Agency, Ministry of Health, University Teaching Hospital Virology Laboratory and ICF International, pg 223–257.

  12. Ayles H, Bond V, Chintu N, Handima N, Kapaku K, Maluzi K et al. (2016). HIV Self Testing Africa-Zambia. A clinical performance study of self-testing using self-collected oral fluid transudate and the OraQuick® HIV Self-Test.

  13. Bossuyt PM, Reitsma JB, Bruns DE, Gatsonis CA, Glasziou PP, Irwig LM. (2003). Towards complete and accurate reporting of studies of diagnostic accuracy: The STARD Initiative. Ann Intern Med 2003;138:40 – 4.: the STARD initiative. BMJ 326: 41–44.

  14. Dessie A, Abera B, Walle F, Wolday D, Tamene W. Evaluation of determine HIV-1/2 rapid diagnostic test by 4th generation ELISA using blood donors’ serum at Felege Hiwot referral hospital, Northwest Ethiopia. Ethiop Med J. 2008;46:1–5.

    PubMed  Google Scholar 

  15. Boadu R, Darko G, Nortey P, Akweongo P, Sarfo B. Assessing the sensitivity and specificity of First Response HIV-1-2 test kit with whole blood and serum samples: a cross-sectional study. AIDS Res Ther. 2016;13:9. https://doiorg.publicaciones.saludcastillayleon.es/10.1186/s12981-016-0092-0.

    Article  PubMed  PubMed Central  Google Scholar 

  16. Kashosi TM, et al. The journal of infection in developing countries, Field accuracy of HIV rapid diagnostic tests for blood donor screening, Bukavu. Eastern Democratic Republic of the Congo; 2018.

  17. Piwowar-Manning EM, Tustin NB, Sikateyo P, Kamwendo D, Chipungu C, Maharaj R, Mushanyu, et al. Validation of Rapid HIV antibody tests in 5 African countries. J Int Association Physicians AIDS Care. 2010;9(3):170–2. https://doiorg.publicaciones.saludcastillayleon.es/10.1177/1545109710368151.

    Article  Google Scholar 

  18. Masciotra S, McDougal JS, Feldman J et al. Evaluation of an alternative HIV diagnostic algorithm using specimens from seroconversion panels and persons with established HIV infections, J Clin Virol, 2011, vol. 52 uppl 1(pg. S17-22).

  19. Rosenberg NE, Kamanga G, Phiri S, Nsona D, Pettifor A, Rutstein SE, Kamwendo D, Hoffman IF, et al. Detection of acute HIV infection: a field evaluation of the determine® HIV-1/2 Ag/Ab combo test. J Infect Dis. 2012;205(4):528–34. https://doiorg.publicaciones.saludcastillayleon.es/10.1093/infdis/jir789.

    Article  CAS  PubMed  Google Scholar 

  20. Lewis JM, Macpherson P, Adams ER, Ochodo E, Sands A, Taegtmeyer M. Field accuracy of fourth-generation rapid diagnostic tests for acute HIV-1: a systematic review. AIDS. 2015;29(18):2465–71. https://doiorg.publicaciones.saludcastillayleon.es/10.1097/QAD.0000000000000855.

    Article  CAS  PubMed  Google Scholar 

  21. Wratil PR, Rabenau HF, Eberle J. Comparative multi-assay evaluation of Determine™ HIV-1/2 Ag/Ab combo rapid diagnostic tests in acute and chronic HIV infection. Med Microbiol Immunol. 2020;209(2):139–50. https://doiorg.publicaciones.saludcastillayleon.es/10.1007/s00430-019-00655-0).

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  22. Centers for Disesase Control and Prevention. (2018). Rapid HIV tests suitable for use in nonclinical settings (requires CLIA waiver certificate). Centers for Disesase Control and Prevention. www.cdc.gov/hiv/pdf/testing_nonclinical_clia-waived-tests. pdf [Accessed 27 April 2021].

  23. Moyo S, Mohammed T, Wirth KE, Prague M, Bennett K, Holme MP, et al. Point-of-care Cepheid Xpert HIV-1 viral load test in rural African communities is feasible and reliable. J Clin Microbiol. 2016;54:3050–5.

    Article  PubMed  PubMed Central  Google Scholar 

  24. Peeling RW, Mabey D. Point-of-care tests for diagnosing infections in the developing world. Clin Microbiol Infect. 2010;16:1062–9.

    Article  CAS  PubMed  Google Scholar 

  25. Michaeli M, Wax M, Gozlan Y, Rakovsky A, Mendelson E, Mor O. Evaluation of xpert HIV-1 qual assay for resolution of HIV-1 infection in samples with negative or indeterminate geenius HIV-1/2 results. J Clin Virol. 2016;76:1–3.

    Article  CAS  PubMed  Google Scholar 

  26. Patel P, Mackellar D, Simmons P. Detecting Acute Human Immunodeficiency Virus infection using 3 different screening immunoassays and nucleic acid amplification testing for human immunodeficiency virus RNA, 2006–2008. Arch Intern Med. 2010;170(1):66–74. https://doiorg.publicaciones.saludcastillayleon.es/10.1001/archinternmed.2009.445.

    Article  CAS  PubMed  Google Scholar 

  27. Zetola NM, Pilcher DC. (2007). Diagnosis and Management of Acute HIV Infection, Infectious Disease Clinics of North America,Volume 21, Issue 1, Pages 19–48, ISSN 0891–5520, https://doiorg.publicaciones.saludcastillayleon.es/10.1016/j.idc.2007.01.008. (2007). Diagnosis and management of acute HIV infection. Infect Dis Clin North Am 21: 19–48.

  28. Morrison CS, Demers K, Kwok C et al. Plasma and cervical viral loads among Ugandan and Zimbabwean women during acute and early HIV-1 infection, AIDS, 2010, vol. 24 (pg. 573 – 82).

  29. Taegtmeyer M, MacPherson P, Jones K. (2011). Programmatic evaluation of a combined antigen and antibody test for rapid HIV diagnosis in a community and sexual health clinic screening programme. PLoS One 2011; 6(11): e28019–e28019.

  30. Beelaert G, Fransen K. Evaluation of a rapid and simple fourth-generation HIV screening assay for qualitative detection of HIV p24 antigen and/or antibodies to HIV-1 and HIV-2. J Virol Methods. 2010;168:218–22.

    Article  CAS  PubMed  Google Scholar 

Download references

Acknowledgements

This research was supported by the Sub-Saharan African Network for TB/HIV Research Excellence (SANTHE) which is funded by the Science for Africa Foundation to the Developing Excellence in Leadership, Training and Science in Africa (DELTAS Africa) programme [Del-22-007] with support from Wellcome Trust and the UK Foreign, Commonwealth & Development Office and is part of the EDCPT2 programme supported by the European Union; the Bill & Melinda Gates Foundation [INV-033558]; and Gilead Sciences Inc., [19275]. All content contained within is that of the authors and does not necessarily reflect positions or policies of any SANTHE funder. For the purpose of open access, the author has applied a CC BY public copyright licence to any Author Accepted Manuscript version arising from this submission. Special acknowledgements to ZAMBART for the opportunity to use the STAR data for this study.

Funding

Not applicable.

Author information

Authors and Affiliations

  1. Center for Family Health Research in Zambia-formerly ZHERP, Lusaka, Zambia

    Loveness Mukuka

  2. Kenyatta National Hospital Complex, Africa CDC, Afya house, Nairobi, Kenya

    Andros Theo

  3. Livingstone University Teaching Hospital, Livingstone, Zambia

    Precious Simushi

  4. Benefits Department, Workers Compensation Fund Control Board, Lusaka, Zambia

    Mowa Zambwe

  5. World Health Organization, Lusaka, Zambia

    Peter J. Chipimo

Authors
  1. Loveness Mukuka
    View author publications

    You can also search for this author inPubMed Google Scholar

  2. Andros Theo
    View author publications

    You can also search for this author inPubMed Google Scholar

  3. Precious Simushi
    View author publications

    You can also search for this author inPubMed Google Scholar

  4. Mowa Zambwe
    View author publications

    You can also search for this author inPubMed Google Scholar

  5. Peter J. Chipimo
    View author publications

    You can also search for this author inPubMed Google Scholar

Contributions

LM and AT conceived the study. LM and AT conducted the data collection and drafting of Manuscript. LM, AT and MZ contributed to data analysis and led the writing of the manuscript. PS, MZ and PJC reviewed the manuscript. All authors read and approved the final manuscript.

Corresponding author

Correspondence to Loveness Mukuka.

Ethics declarations

Competing interests

The authors declare no competing interests.

Ethical approval and consent to participate

Ethical approval was granted by the University of Lusaka, medical Ethics Committee. All methods were carried out in accordance with relevant guidelines and regulations with relevant authorizations from Ministry of Health. Consent to participate was obtained. For participants with ages less than 18 years, informed consent was obtained from their parent(s)/guardian(s) as well. Informed consent was obtained from participants and management before the study.

Consent to publish

Not applicable.

Additional information

Publisher’s note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Rights and permissions

Open Access This article is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License, which permits any non-commercial use, sharing, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if you modified the licensed material. You do not have permission under this licence to share adapted material derived from this article or parts of it. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc-nd/4.0/.

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Mukuka, L., Theo, A., Simushi, P. et al. A comparative analysis of the different HIV testing techniques used in Zambia: data from a clinical performance study. BMC Res Notes 18, 131 (2025). https://doiorg.publicaciones.saludcastillayleon.es/10.1186/s13104-024-07041-x

Download citation

  • Received:

  • Accepted:

  • Published:

  • DOI: https://doiorg.publicaciones.saludcastillayleon.es/10.1186/s13104-024-07041-x

Keywords

BMC Research Notes

ISSN: 1756-0500

Contact us