Case Scenario on the Qualities of HIV Rapid Test Kits

Mekashaw Tebeje Sisay; Mulat Woldie Wondimagegn; Huluagerish Nemera Woyessa

doi:doi:10.11648/j.ajlm.20220704.11

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Case Scenario on the Qualities of HIV Rapid Test Kits

Mekashaw Tebeje Sisay, Mulat Woldie Wondimagegn, Huluagerish Nemera Woyessa

Published in American Journal of Laboratory Medicine (Volume 7, Issue 4)

Received: 15 August 2022 Accepted: 7 September 2022 Published: 19 September 2022

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Abstract

The diagnosis of HIV in resource-limited settings is performed based on an algorithm employing 2–3 rapid diagnostic tests (RDTs). This strategy has allowed a lifesaving scale-up of HIV diagnosis, as it permits testing to be decentralized outside of the laboratory. Even though the situation is minimal, some individuals will be falsely diagnosed as HIV positive in this strategy. When the clinical conditions, patient history, and results are not concorded, samples repeatedly tested positive on screening assays can be tested by a supplementary assay, and if negative by using nucleic acid testing (NAT). In our case the scenario was different, the woman who had married a husband living with HIV, had signs and symptoms of HIV was tested for HIV and the first test-Stat-pack result was negative. In this case, the counselor who was strong-minded that the woman is positive did the second and third tests and the results were reactive. Finally, the result was determined by NAT testing, and it was positive for HIV. Looking at this incident and reading the case reports in other countries, we realized that clients’ history and exposure to risk behaviors need to be considered before reporting that the client is negative for HIV. We also recommend that low- or middle-income countries to have supplementary testing technologies to prevent missed opportunities and to provide NAT testing for HIV-negative clients who had a history of exposure to HIV-positive individuals and had clinical manifestations of HIV.

Published in	American Journal of Laboratory Medicine (Volume 7, Issue 4)
DOI	10.11648/j.ajlm.20220704.11
Page(s)	49-51
Creative Commons	This is an Open Access article, distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution and reproduction in any medium or format, provided the original work is properly cited.
Copyright	Copyright © The Author(s), 2022. Published by Science Publishing Group

Keywords

Rapid Diagnostic Test, False Negative Diagnosis, False Positive Diagnosis, Rapid Test for Recent Infection, NAT, Risk Behaviors

References

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[2]	Understanding Fast-Track: accelerating action to end the AIDS epidemic by 2030. UNAIDS Geneva; 2015 (https://www.unaids.org/sites/default/files/media_asset/201506_JC2743_Understanding_FastTrack_en.pdf, accessed 1 June 2021)
[3]	Consolidated guidelines on HIV prevention, testing, treatment, service delivery and monitoring: recommendations for a public health approach. Geneva: World Health Organization; 2021. Licence: CC BY-NC-SA 3.0 IGO.
[4]	Shanks et al. Evaluation of HIV testing algorithms in Ethiopia: the role of the tie-breaker algorithm and weakly reacting test lines in contributing to a high rate of false positive HIV diagnoses: BMC Infectious Diseases (2015) 15: 39 DOI 10.1186/s12879-015-0769-3.
[5]	Optimizing HIV testing algorithms: a generic verification protocol for selecting appropriate HIV serology assays and assessing the level of shared false reactivity. Geneva: World Health Organization; 2021. Licence: CC BY-NC-SA 3.0 IGO.
[6]	Global programme on AIDS. Recommendations for the selection and use of HIV antibody tests. Wkly Epidemiol Rec. 1992 May 15; 67 (20): 145-9. English, French. PMID: 1599842.
[7]	Kroidl I, Clowes P, Mwalongo W, Maganga L, Maboko L, et al. (2012) Low Specificity of Determine HIV1/2 RDT Using Whole Blood in Southwest Tanzania. PLoS ONE 7 (6): e39529. doi: 10.1371/journal.pone.0039529.
[8]	World Health Organization. Service delivery approaches to HIV testing and Counselling (HTC). Geneva: WHO; 2012.
[9]	Centers for Disease Control and Prevention. HIV prevention strategic plan through 2005. January 2001. Available from: URL: http:// www.cdc.gov/hiv/pubs/prev-strat-plan.pdf
[10]	Nyirenda Mulinda, Kumwenda Johnstone J, Kumwenda Newton. Case Report: HIV test misdiagnosis. Malawi Medical Journal; 23 (4): 119-120 December 2011.
[11]	Pavie J, Rachline A, Loze B, Niedbalski L, Delaugerre C, et al. (2010) Sensitivity of Five Rapid HIV Tests on Oral Fluid or Finger-Stick Whole Blood: A RealTime Comparison in a Healthcare Setting. PLoS ONE 5 (7): e11581. doi: 10.1371/journal.pone.0011581.
[12]	W. Kirch & C. Schafii. Reflections on misdiagnosis. Journal of internal medicine. 1994; 235: 399-404.
[13]	Klarkowski D, O'Brien DP, Shanks L, Singh KP. Causes of false-positive HIV rapid diagnostic test results. Expert Rev Anti Infect Ther. 2014 Jan; 12 (1): 49-62. doi: 10.1586/14787210.2014.866516. PMID: 24404993.
[14]	Center for Disease prevention and Control. Laboratory Procedure Manual for HIV Antibody / HIV Western Blot Confirmatory Test; 2007.
[15]	Shanks et al.: Dilution testing using rapid diagnostic tests in a HIV diagnostic algorithm: a novel alternative for confirmation testing in resource limited settings. Virology Journal (2015) 12: 75).

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APA Style

Mekashaw Tebeje Sisay, Mulat Woldie Wondimagegn, Huluagerish Nemera Woyessa. (2022). Case Scenario on the Qualities of HIV Rapid Test Kits. American Journal of Laboratory Medicine, 7(4), 49-51. https://doi.org/10.11648/j.ajlm.20220704.11

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ACS Style

Mekashaw Tebeje Sisay; Mulat Woldie Wondimagegn; Huluagerish Nemera Woyessa. Case Scenario on the Qualities of HIV Rapid Test Kits. Am. J. Lab. Med. 2022, 7(4), 49-51. doi: 10.11648/j.ajlm.20220704.11

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AMA Style

Mekashaw Tebeje Sisay, Mulat Woldie Wondimagegn, Huluagerish Nemera Woyessa. Case Scenario on the Qualities of HIV Rapid Test Kits. Am J Lab Med. 2022;7(4):49-51. doi: 10.11648/j.ajlm.20220704.11

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@article{10.11648/j.ajlm.20220704.11,
  author = {Mekashaw Tebeje Sisay and Mulat Woldie Wondimagegn and Huluagerish Nemera Woyessa},
  title = {Case Scenario on the Qualities of HIV Rapid Test Kits},
  journal = {American Journal of Laboratory Medicine},
  volume = {7},
  number = {4},
  pages = {49-51},
  doi = {10.11648/j.ajlm.20220704.11},
  url = {https://doi.org/10.11648/j.ajlm.20220704.11},
  eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.ajlm.20220704.11},
  abstract = {The diagnosis of HIV in resource-limited settings is performed based on an algorithm employing 2–3 rapid diagnostic tests (RDTs). This strategy has allowed a lifesaving scale-up of HIV diagnosis, as it permits testing to be decentralized outside of the laboratory. Even though the situation is minimal, some individuals will be falsely diagnosed as HIV positive in this strategy. When the clinical conditions, patient history, and results are not concorded, samples repeatedly tested positive on screening assays can be tested by a supplementary assay, and if negative by using nucleic acid testing (NAT). In our case the scenario was different, the woman who had married a husband living with HIV, had signs and symptoms of HIV was tested for HIV and the first test-Stat-pack result was negative. In this case, the counselor who was strong-minded that the woman is positive did the second and third tests and the results were reactive. Finally, the result was determined by NAT testing, and it was positive for HIV. Looking at this incident and reading the case reports in other countries, we realized that clients’ history and exposure to risk behaviors need to be considered before reporting that the client is negative for HIV. We also recommend that low- or middle-income countries to have supplementary testing technologies to prevent missed opportunities and to provide NAT testing for HIV-negative clients who had a history of exposure to HIV-positive individuals and had clinical manifestations of HIV.},
 year = {2022}
}

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TY  - JOUR
T1  - Case Scenario on the Qualities of HIV Rapid Test Kits
AU  - Mekashaw Tebeje Sisay
AU  - Mulat Woldie Wondimagegn
AU  - Huluagerish Nemera Woyessa
Y1  - 2022/09/19
PY  - 2022
N1  - https://doi.org/10.11648/j.ajlm.20220704.11
DO  - 10.11648/j.ajlm.20220704.11
T2  - American Journal of Laboratory Medicine
JF  - American Journal of Laboratory Medicine
JO  - American Journal of Laboratory Medicine
SP  - 49
EP  - 51
PB  - Science Publishing Group
SN  - 2575-386X
UR  - https://doi.org/10.11648/j.ajlm.20220704.11
AB  - The diagnosis of HIV in resource-limited settings is performed based on an algorithm employing 2–3 rapid diagnostic tests (RDTs). This strategy has allowed a lifesaving scale-up of HIV diagnosis, as it permits testing to be decentralized outside of the laboratory. Even though the situation is minimal, some individuals will be falsely diagnosed as HIV positive in this strategy. When the clinical conditions, patient history, and results are not concorded, samples repeatedly tested positive on screening assays can be tested by a supplementary assay, and if negative by using nucleic acid testing (NAT). In our case the scenario was different, the woman who had married a husband living with HIV, had signs and symptoms of HIV was tested for HIV and the first test-Stat-pack result was negative. In this case, the counselor who was strong-minded that the woman is positive did the second and third tests and the results were reactive. Finally, the result was determined by NAT testing, and it was positive for HIV. Looking at this incident and reading the case reports in other countries, we realized that clients’ history and exposure to risk behaviors need to be considered before reporting that the client is negative for HIV. We also recommend that low- or middle-income countries to have supplementary testing technologies to prevent missed opportunities and to provide NAT testing for HIV-negative clients who had a history of exposure to HIV-positive individuals and had clinical manifestations of HIV.
VL  - 7
IS  - 4
ER  -

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Author Information

Mekashaw Tebeje Sisay

International Centre for AIDS Care and Treatment Programs in Ethiopia, Department of Strategic Information, Columbia University, Addis Ababa, Ethiopia
Mulat Woldie Wondimagegn

Department of Public Health, Yekatit 12 Hospital Medical College, Addis Ababa, Ethiopia
Huluagerish Nemera Woyessa

Department of Tuberculosis/Human Immuno-Deficiency Virus, Addis Ababa Administration Health Bureau, Addis Ababa, Ethiopia

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APA Style

Mekashaw Tebeje Sisay, Mulat Woldie Wondimagegn, Huluagerish Nemera Woyessa. (2022). Case Scenario on the Qualities of HIV Rapid Test Kits. American Journal of Laboratory Medicine, 7(4), 49-51. https://doi.org/10.11648/j.ajlm.20220704.11

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ACS Style

Mekashaw Tebeje Sisay; Mulat Woldie Wondimagegn; Huluagerish Nemera Woyessa. Case Scenario on the Qualities of HIV Rapid Test Kits. Am. J. Lab. Med. 2022, 7(4), 49-51. doi: 10.11648/j.ajlm.20220704.11

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AMA Style

Mekashaw Tebeje Sisay, Mulat Woldie Wondimagegn, Huluagerish Nemera Woyessa. Case Scenario on the Qualities of HIV Rapid Test Kits. Am J Lab Med. 2022;7(4):49-51. doi: 10.11648/j.ajlm.20220704.11

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@article{10.11648/j.ajlm.20220704.11,
  author = {Mekashaw Tebeje Sisay and Mulat Woldie Wondimagegn and Huluagerish Nemera Woyessa},
  title = {Case Scenario on the Qualities of HIV Rapid Test Kits},
  journal = {American Journal of Laboratory Medicine},
  volume = {7},
  number = {4},
  pages = {49-51},
  doi = {10.11648/j.ajlm.20220704.11},
  url = {https://doi.org/10.11648/j.ajlm.20220704.11},
  eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.ajlm.20220704.11},
  abstract = {The diagnosis of HIV in resource-limited settings is performed based on an algorithm employing 2–3 rapid diagnostic tests (RDTs). This strategy has allowed a lifesaving scale-up of HIV diagnosis, as it permits testing to be decentralized outside of the laboratory. Even though the situation is minimal, some individuals will be falsely diagnosed as HIV positive in this strategy. When the clinical conditions, patient history, and results are not concorded, samples repeatedly tested positive on screening assays can be tested by a supplementary assay, and if negative by using nucleic acid testing (NAT). In our case the scenario was different, the woman who had married a husband living with HIV, had signs and symptoms of HIV was tested for HIV and the first test-Stat-pack result was negative. In this case, the counselor who was strong-minded that the woman is positive did the second and third tests and the results were reactive. Finally, the result was determined by NAT testing, and it was positive for HIV. Looking at this incident and reading the case reports in other countries, we realized that clients’ history and exposure to risk behaviors need to be considered before reporting that the client is negative for HIV. We also recommend that low- or middle-income countries to have supplementary testing technologies to prevent missed opportunities and to provide NAT testing for HIV-negative clients who had a history of exposure to HIV-positive individuals and had clinical manifestations of HIV.},
 year = {2022}
}

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TY  - JOUR
T1  - Case Scenario on the Qualities of HIV Rapid Test Kits
AU  - Mekashaw Tebeje Sisay
AU  - Mulat Woldie Wondimagegn
AU  - Huluagerish Nemera Woyessa
Y1  - 2022/09/19
PY  - 2022
N1  - https://doi.org/10.11648/j.ajlm.20220704.11
DO  - 10.11648/j.ajlm.20220704.11
T2  - American Journal of Laboratory Medicine
JF  - American Journal of Laboratory Medicine
JO  - American Journal of Laboratory Medicine
SP  - 49
EP  - 51
PB  - Science Publishing Group
SN  - 2575-386X
UR  - https://doi.org/10.11648/j.ajlm.20220704.11
AB  - The diagnosis of HIV in resource-limited settings is performed based on an algorithm employing 2–3 rapid diagnostic tests (RDTs). This strategy has allowed a lifesaving scale-up of HIV diagnosis, as it permits testing to be decentralized outside of the laboratory. Even though the situation is minimal, some individuals will be falsely diagnosed as HIV positive in this strategy. When the clinical conditions, patient history, and results are not concorded, samples repeatedly tested positive on screening assays can be tested by a supplementary assay, and if negative by using nucleic acid testing (NAT). In our case the scenario was different, the woman who had married a husband living with HIV, had signs and symptoms of HIV was tested for HIV and the first test-Stat-pack result was negative. In this case, the counselor who was strong-minded that the woman is positive did the second and third tests and the results were reactive. Finally, the result was determined by NAT testing, and it was positive for HIV. Looking at this incident and reading the case reports in other countries, we realized that clients’ history and exposure to risk behaviors need to be considered before reporting that the client is negative for HIV. We also recommend that low- or middle-income countries to have supplementary testing technologies to prevent missed opportunities and to provide NAT testing for HIV-negative clients who had a history of exposure to HIV-positive individuals and had clinical manifestations of HIV.
VL  - 7
IS  - 4
ER  -

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