Laboratory Evaluation of the Validity of the Current HIV Testing Algorithm in Kenya

James Kimotho; Zipporah Ng’ang’a; Edna Nyairo; Missiani Ochwoto; Nicholas Nzioka; Francis Ogolla; Michael Kiptoo

doi:doi:10.11648/j.ajim.20150301.14

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Laboratory Evaluation of the Validity of the Current HIV Testing Algorithm in Kenya

James Kimotho, Zipporah Ng’ang’a, Edna Nyairo, Missiani Ochwoto, Nicholas Nzioka, Francis Ogolla, Michael Kiptoo

Published in American Journal of Internal Medicine (Volume 3, Issue 1)

Received: 30 January 2015 Accepted: 9 February 2015 Published: 15 February 2015

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Abstract

Background: The HIV Lateral Flow Tests (LFTs) provide a good compromise between accuracy, cost, speed and overall effectiveness. Objective: This study assessed the laboratory performance of the LFTs in the current National HIV Testing Algorithm in Kenya. Methods: Four hundred blood samples, 145 HIV positives and 255 HIV negatives, were collected from the Regional Blood Transfusion Centers in Kenya. They were analyzed using five LFTs, three of which were in the HIV Testing Algorithm in Kenya. Samples were also tested using Vironostika™ Uni-Form II Ag/Ab ELISA as a Gold Standard. The decision on the HIV status of the samples was determined by consensus status of the five LFTs. Diagnostic sensitivity (D-SN), specificity (D-SP), Positive Predictive Value (PPV) and Negative Predictive Value (NPV) were then computed together with relative Analytical sensitivity each LFT. Results: The three LFTs in the HIV Testing Algorithm in Kenya (KHB Colloidal Gold, First Response™ 1-2.0 and Uni-Gold™ HIV test) showed a D-SN of 100% (95% CI: 97.4-100.0), 96.4% (95% CI: 91.8 - 98.8) and 100% (95% CI: 97.4-100.0) respectively in relation to the Consensus status with LFTs. However, Determine™ HIV-1/2 showed the highest Analytical sensitivity when compared with two other kits in HIV Testing Algorithm in Kenya and Aware™ HIV-1/2 BSP kit. Conclusion: Though the LFTs in the current HIV Testing Algorithm in Kenya show high performance profiles, Determine™ HIV-1/2 showed higher Analytical sensitivity profile than the two HIV Screening and confirmation test kits. There is a need of reconsidering the financial savings (of 10-16%) vis-ȃ-vis the possibilities of missing HIV positive cases in the current HIV Testing Algorithm in Kenya.

Published in	American Journal of Internal Medicine (Volume 3, Issue 1)
DOI	10.11648/j.ajim.20150301.14
Page(s)	23-27
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), 2015. Published by Science Publishing Group

Keywords

Lateral Flow Tests, HIV, Testing Algorithm in Kenya, Sensitivity, Predictive Value, Specificity

References

[1]	WHO-EMRO, Rapid HIV Tests: Guidelines for use in HIV testing and counseling services in resource-constrained setting. 2004.
[2]	Van Binsbergen, J.d.R., D.; Peels, H.; Dries, C.; Scherders, J.; Koolen, M. Zekeng, L. and Gürtler, L.G., Evaluation of a new third generation anti-HIV-1/anti-HIV-2 assay with increased sensitivity for HIV-1 group O. Journal of Virological Methods, 1996. 60(2): p. 131-7.
[3]	Wong, E., Y.; Indira, K. and Hewlett, 1, HIV Diagnostics: Challenges and Opportunities: Rapid & PoC Testing in RLS. HIV Therapy, 2010. 4(4): p. 399-412.
[4]	WHO, HIV assays operational characteristics: HIV rapid diagnostic tests (detection of HIV-1/2 antibodies). report 2013. 17.
[5]	National AIDS and STI Control Programme, M.o.P.H.a.S., Kenya, Guidelines for HIV Testing and Counselling in Kenya. NASCOP, 2008.
[6]	Plate, D.K., Evaluation and implementation of rapid HIV tests:the experience in 11 African countries. AIDS Res Hum Retroviruses, 2007. 23: p. 1491–1498.
[7]	TDR, Evaluation of diagnostic tests for infectious diseases: general principles. 2010.
[8]	Ministry of Public Health and Sanitation, K., Circular No. MPHS/ADM/1/12 dated 6th February 2013
[9]	Madisa, M.C., S; Kgomotso, S.; Taurayi, T, Performance of Rapid HIV Testing by Lay Counsellors in the Field during the Behavioural and Biological Surveillance Survey among Female Sex Workers and Men who have Sex with Men in Botswana. Journal of acquired Immune Deficiency Syndromes
[10]	Fabiani, M.N., B.; Biryahwaho, B.; Ouma, J.; Ninci, A.; Declich, S., Evaluating HIV testing algorithms for research, diagnosis and surveillance. health policy and development, 2005. 3(1).
[11]	Slev, P., The changing landscape of HIV diagnostics. Medical Laboratory Observer: Cover Story, 2012.
[12]	Lyer, P., Mwai, D., Ng'ang'a, A., Costing Kenya’s current and proposed HIV testing and Counseling Algorithms. Health Policy Project 2013.
[13]	Pebody, R., Large US study shows which HIV tests are most accurate; Antibody-only tests need to be replaced with combination tests; Antibody-only tests need to be replaced with combination tests. NAM AIDS MAP, 2014.

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APA Style

James Kimotho, Zipporah Ng’ang’a, Edna Nyairo, Missiani Ochwoto, Nicholas Nzioka, et al. (2015). Laboratory Evaluation of the Validity of the Current HIV Testing Algorithm in Kenya. American Journal of Internal Medicine, 3(1), 23-27. https://doi.org/10.11648/j.ajim.20150301.14

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ACS Style

James Kimotho; Zipporah Ng’ang’a; Edna Nyairo; Missiani Ochwoto; Nicholas Nzioka, et al. Laboratory Evaluation of the Validity of the Current HIV Testing Algorithm in Kenya. Am. J. Intern. Med. 2015, 3(1), 23-27. doi: 10.11648/j.ajim.20150301.14

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AMA Style

James Kimotho, Zipporah Ng’ang’a, Edna Nyairo, Missiani Ochwoto, Nicholas Nzioka, et al. Laboratory Evaluation of the Validity of the Current HIV Testing Algorithm in Kenya. Am J Intern Med. 2015;3(1):23-27. doi: 10.11648/j.ajim.20150301.14

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@article{10.11648/j.ajim.20150301.14,
  author = {James Kimotho and Zipporah Ng’ang’a and Edna Nyairo and Missiani Ochwoto and Nicholas Nzioka and Francis Ogolla and Michael Kiptoo},
  title = {Laboratory Evaluation of the Validity of the Current HIV Testing Algorithm in Kenya},
  journal = {American Journal of Internal Medicine},
  volume = {3},
  number = {1},
  pages = {23-27},
  doi = {10.11648/j.ajim.20150301.14},
  url = {https://doi.org/10.11648/j.ajim.20150301.14},
  eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.ajim.20150301.14},
  abstract = {Background: The HIV Lateral Flow Tests (LFTs) provide a good compromise between accuracy, cost, speed and overall effectiveness. Objective: This study assessed the laboratory performance of the LFTs in the current National HIV Testing Algorithm in Kenya. Methods: Four hundred blood samples, 145 HIV positives and 255 HIV negatives, were collected from the Regional Blood Transfusion Centers in Kenya. They were analyzed using five LFTs, three of which were in the HIV Testing Algorithm in Kenya. Samples were also tested using Vironostika™ Uni-Form II Ag/Ab ELISA as a Gold Standard. The decision on the HIV status of the samples was determined by consensus status of the five LFTs. Diagnostic sensitivity (D-SN), specificity (D-SP), Positive Predictive Value (PPV) and Negative Predictive Value (NPV) were then computed together with relative Analytical sensitivity each LFT. Results: The three LFTs in the HIV Testing Algorithm in Kenya (KHB Colloidal Gold, First Response™ 1-2.0 and Uni-Gold™ HIV test) showed a D-SN of 100% (95% CI: 97.4-100.0), 96.4% (95% CI: 91.8 - 98.8) and 100% (95% CI: 97.4-100.0) respectively in relation to the Consensus status with LFTs. However, Determine™ HIV-1/2 showed the highest Analytical sensitivity when compared with two other kits in HIV Testing Algorithm in Kenya and Aware™ HIV-1/2 BSP kit. Conclusion: Though the LFTs in the current HIV Testing Algorithm in Kenya show high performance profiles, Determine™ HIV-1/2 showed higher Analytical sensitivity profile than the two HIV Screening and confirmation test kits. There is a need of reconsidering the financial savings (of 10-16%) vis-ȃ-vis the possibilities of missing HIV positive cases in the current HIV Testing Algorithm in Kenya.},
 year = {2015}
}

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TY  - JOUR
T1  - Laboratory Evaluation of the Validity of the Current HIV Testing Algorithm in Kenya
AU  - James Kimotho
AU  - Zipporah Ng’ang’a
AU  - Edna Nyairo
AU  - Missiani Ochwoto
AU  - Nicholas Nzioka
AU  - Francis Ogolla
AU  - Michael Kiptoo
Y1  - 2015/02/15
PY  - 2015
N1  - https://doi.org/10.11648/j.ajim.20150301.14
DO  - 10.11648/j.ajim.20150301.14
T2  - American Journal of Internal Medicine
JF  - American Journal of Internal Medicine
JO  - American Journal of Internal Medicine
SP  - 23
EP  - 27
PB  - Science Publishing Group
SN  - 2330-4324
UR  - https://doi.org/10.11648/j.ajim.20150301.14
AB  - Background: The HIV Lateral Flow Tests (LFTs) provide a good compromise between accuracy, cost, speed and overall effectiveness. Objective: This study assessed the laboratory performance of the LFTs in the current National HIV Testing Algorithm in Kenya. Methods: Four hundred blood samples, 145 HIV positives and 255 HIV negatives, were collected from the Regional Blood Transfusion Centers in Kenya. They were analyzed using five LFTs, three of which were in the HIV Testing Algorithm in Kenya. Samples were also tested using Vironostika™ Uni-Form II Ag/Ab ELISA as a Gold Standard. The decision on the HIV status of the samples was determined by consensus status of the five LFTs. Diagnostic sensitivity (D-SN), specificity (D-SP), Positive Predictive Value (PPV) and Negative Predictive Value (NPV) were then computed together with relative Analytical sensitivity each LFT. Results: The three LFTs in the HIV Testing Algorithm in Kenya (KHB Colloidal Gold, First Response™ 1-2.0 and Uni-Gold™ HIV test) showed a D-SN of 100% (95% CI: 97.4-100.0), 96.4% (95% CI: 91.8 - 98.8) and 100% (95% CI: 97.4-100.0) respectively in relation to the Consensus status with LFTs. However, Determine™ HIV-1/2 showed the highest Analytical sensitivity when compared with two other kits in HIV Testing Algorithm in Kenya and Aware™ HIV-1/2 BSP kit. Conclusion: Though the LFTs in the current HIV Testing Algorithm in Kenya show high performance profiles, Determine™ HIV-1/2 showed higher Analytical sensitivity profile than the two HIV Screening and confirmation test kits. There is a need of reconsidering the financial savings (of 10-16%) vis-ȃ-vis the possibilities of missing HIV positive cases in the current HIV Testing Algorithm in Kenya.
VL  - 3
IS  - 1
ER  -

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Author Information

James Kimotho

Kenya Medical Research Institute, Nairobi, Kenya
Zipporah Ng’ang’a

Jomo Kenyatta University of Agriculture and Technology, Institute of Tropical Medicine, Thika, Kenya
Edna Nyairo

Kenya Medical Research Institute, Nairobi, Kenya
Missiani Ochwoto

Kenya Medical Research Institute, Nairobi, Kenya
Nicholas Nzioka

Kenya Medical Research Institute, Nairobi, Kenya
Francis Ogolla

Kenya Medical Research Institute, Nairobi, Kenya
Michael Kiptoo

Kenya Medical Research Institute, Nairobi, Kenya

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APA Style

James Kimotho, Zipporah Ng’ang’a, Edna Nyairo, Missiani Ochwoto, Nicholas Nzioka, et al. (2015). Laboratory Evaluation of the Validity of the Current HIV Testing Algorithm in Kenya. American Journal of Internal Medicine, 3(1), 23-27. https://doi.org/10.11648/j.ajim.20150301.14

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ACS Style

James Kimotho; Zipporah Ng’ang’a; Edna Nyairo; Missiani Ochwoto; Nicholas Nzioka, et al. Laboratory Evaluation of the Validity of the Current HIV Testing Algorithm in Kenya. Am. J. Intern. Med. 2015, 3(1), 23-27. doi: 10.11648/j.ajim.20150301.14

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AMA Style

James Kimotho, Zipporah Ng’ang’a, Edna Nyairo, Missiani Ochwoto, Nicholas Nzioka, et al. Laboratory Evaluation of the Validity of the Current HIV Testing Algorithm in Kenya. Am J Intern Med. 2015;3(1):23-27. doi: 10.11648/j.ajim.20150301.14

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@article{10.11648/j.ajim.20150301.14,
  author = {James Kimotho and Zipporah Ng’ang’a and Edna Nyairo and Missiani Ochwoto and Nicholas Nzioka and Francis Ogolla and Michael Kiptoo},
  title = {Laboratory Evaluation of the Validity of the Current HIV Testing Algorithm in Kenya},
  journal = {American Journal of Internal Medicine},
  volume = {3},
  number = {1},
  pages = {23-27},
  doi = {10.11648/j.ajim.20150301.14},
  url = {https://doi.org/10.11648/j.ajim.20150301.14},
  eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.ajim.20150301.14},
  abstract = {Background: The HIV Lateral Flow Tests (LFTs) provide a good compromise between accuracy, cost, speed and overall effectiveness. Objective: This study assessed the laboratory performance of the LFTs in the current National HIV Testing Algorithm in Kenya. Methods: Four hundred blood samples, 145 HIV positives and 255 HIV negatives, were collected from the Regional Blood Transfusion Centers in Kenya. They were analyzed using five LFTs, three of which were in the HIV Testing Algorithm in Kenya. Samples were also tested using Vironostika™ Uni-Form II Ag/Ab ELISA as a Gold Standard. The decision on the HIV status of the samples was determined by consensus status of the five LFTs. Diagnostic sensitivity (D-SN), specificity (D-SP), Positive Predictive Value (PPV) and Negative Predictive Value (NPV) were then computed together with relative Analytical sensitivity each LFT. Results: The three LFTs in the HIV Testing Algorithm in Kenya (KHB Colloidal Gold, First Response™ 1-2.0 and Uni-Gold™ HIV test) showed a D-SN of 100% (95% CI: 97.4-100.0), 96.4% (95% CI: 91.8 - 98.8) and 100% (95% CI: 97.4-100.0) respectively in relation to the Consensus status with LFTs. However, Determine™ HIV-1/2 showed the highest Analytical sensitivity when compared with two other kits in HIV Testing Algorithm in Kenya and Aware™ HIV-1/2 BSP kit. Conclusion: Though the LFTs in the current HIV Testing Algorithm in Kenya show high performance profiles, Determine™ HIV-1/2 showed higher Analytical sensitivity profile than the two HIV Screening and confirmation test kits. There is a need of reconsidering the financial savings (of 10-16%) vis-ȃ-vis the possibilities of missing HIV positive cases in the current HIV Testing Algorithm in Kenya.},
 year = {2015}
}

Copy | Download

TY  - JOUR
T1  - Laboratory Evaluation of the Validity of the Current HIV Testing Algorithm in Kenya
AU  - James Kimotho
AU  - Zipporah Ng’ang’a
AU  - Edna Nyairo
AU  - Missiani Ochwoto
AU  - Nicholas Nzioka
AU  - Francis Ogolla
AU  - Michael Kiptoo
Y1  - 2015/02/15
PY  - 2015
N1  - https://doi.org/10.11648/j.ajim.20150301.14
DO  - 10.11648/j.ajim.20150301.14
T2  - American Journal of Internal Medicine
JF  - American Journal of Internal Medicine
JO  - American Journal of Internal Medicine
SP  - 23
EP  - 27
PB  - Science Publishing Group
SN  - 2330-4324
UR  - https://doi.org/10.11648/j.ajim.20150301.14
AB  - Background: The HIV Lateral Flow Tests (LFTs) provide a good compromise between accuracy, cost, speed and overall effectiveness. Objective: This study assessed the laboratory performance of the LFTs in the current National HIV Testing Algorithm in Kenya. Methods: Four hundred blood samples, 145 HIV positives and 255 HIV negatives, were collected from the Regional Blood Transfusion Centers in Kenya. They were analyzed using five LFTs, three of which were in the HIV Testing Algorithm in Kenya. Samples were also tested using Vironostika™ Uni-Form II Ag/Ab ELISA as a Gold Standard. The decision on the HIV status of the samples was determined by consensus status of the five LFTs. Diagnostic sensitivity (D-SN), specificity (D-SP), Positive Predictive Value (PPV) and Negative Predictive Value (NPV) were then computed together with relative Analytical sensitivity each LFT. Results: The three LFTs in the HIV Testing Algorithm in Kenya (KHB Colloidal Gold, First Response™ 1-2.0 and Uni-Gold™ HIV test) showed a D-SN of 100% (95% CI: 97.4-100.0), 96.4% (95% CI: 91.8 - 98.8) and 100% (95% CI: 97.4-100.0) respectively in relation to the Consensus status with LFTs. However, Determine™ HIV-1/2 showed the highest Analytical sensitivity when compared with two other kits in HIV Testing Algorithm in Kenya and Aware™ HIV-1/2 BSP kit. Conclusion: Though the LFTs in the current HIV Testing Algorithm in Kenya show high performance profiles, Determine™ HIV-1/2 showed higher Analytical sensitivity profile than the two HIV Screening and confirmation test kits. There is a need of reconsidering the financial savings (of 10-16%) vis-ȃ-vis the possibilities of missing HIV positive cases in the current HIV Testing Algorithm in Kenya.
VL  - 3
IS  - 1
ER  -

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