Performance of Cepheid Xpert HIV-1 viral load plasma assay to accurately detect treatment failure

Jilian A. Sacks, Youyi Fong, Mercedes Perez Gonzalez, Mauro Andreotti, Shrikala Baliga, Nigel Garrett, Jeanne Jordan, Etienne Karita, Smita Kulkarni, Orna Mor, Fausta Mosha, Zibusiso Ndlovu, Jean Christophe Plantier, Shanmugam Saravanan, Lesley Scott, Trevor Peter, Meg Doherty, Lara Vojnov

Research output: Contribution to journalArticle

Abstract

Background: Coverage of viral load testing remains low with only half of the patients in need having adequate access. Alternative technologies to high throughput centralized machines can be used to support viral load scale-up; however, clinical performance data are lacking. We conducted a meta-analysis comparing the Cepheid Xpert HIV-1 viral load plasma assay to traditional laboratory-based technologies. Methods: Cepheid Xpert HIV-1 and comparator laboratory technology plasma viral load results were provided from 13 of the 19 eligible studies, which accounted for a total of 3790 paired data points. We used random effects models to determine the accuracy and misclassification at various treatment failure thresholds (detectable, 200, 400, 500, 600, 800 and 1000copies/ml). Results: Thirty percent of viral load test results were undetectable, while 45% were between detectable and 10000copies/ml and the remaining 25% were above 10000copies/ml. The median Xpert viral load was 119copies/ml and the median comparator viral load was 157copies/ml, while the log10 bias was 0.04 (0.02-0.07). The sensitivity and specificity to detect treatment failure were above 95% at all treatment failure thresholds, except for detectable, at which the sensitivity was 93.33% (95% confidence interval: 88.2-96.3) and specificity was 80.56% (95% CI: 64.6-90.4). Conclusion: The Cepheid Xpert HIV-1 viral load plasma assay results were highly comparable to laboratory-based technologies with limited bias and high sensitivity and specificity to detect treatment failure. Alternative specimen types and technologies that enable decentralized testing services can be considered to expand access to viral load.

Original languageEnglish
Pages (from-to)1881-1889
Number of pages9
JournalAIDS
Volume33
Issue number12
DOIs
Publication statusPublished - 01-10-2019

Fingerprint

Viral Load
Treatment Failure
HIV-1
Technology
Sensitivity and Specificity
Meta-Analysis
Confidence Intervals

All Science Journal Classification (ASJC) codes

  • Immunology and Allergy
  • Immunology
  • Infectious Diseases

Cite this

Sacks, J. A., Fong, Y., Gonzalez, M. P., Andreotti, M., Baliga, S., Garrett, N., ... Vojnov, L. (2019). Performance of Cepheid Xpert HIV-1 viral load plasma assay to accurately detect treatment failure. AIDS, 33(12), 1881-1889. https://doi.org/10.1097/QAD.0000000000002303
Sacks, Jilian A. ; Fong, Youyi ; Gonzalez, Mercedes Perez ; Andreotti, Mauro ; Baliga, Shrikala ; Garrett, Nigel ; Jordan, Jeanne ; Karita, Etienne ; Kulkarni, Smita ; Mor, Orna ; Mosha, Fausta ; Ndlovu, Zibusiso ; Plantier, Jean Christophe ; Saravanan, Shanmugam ; Scott, Lesley ; Peter, Trevor ; Doherty, Meg ; Vojnov, Lara. / Performance of Cepheid Xpert HIV-1 viral load plasma assay to accurately detect treatment failure. In: AIDS. 2019 ; Vol. 33, No. 12. pp. 1881-1889.
@article{3d2a9c67cd55407c8d7125c5128f6a2c,
title = "Performance of Cepheid Xpert HIV-1 viral load plasma assay to accurately detect treatment failure",
abstract = "Background: Coverage of viral load testing remains low with only half of the patients in need having adequate access. Alternative technologies to high throughput centralized machines can be used to support viral load scale-up; however, clinical performance data are lacking. We conducted a meta-analysis comparing the Cepheid Xpert HIV-1 viral load plasma assay to traditional laboratory-based technologies. Methods: Cepheid Xpert HIV-1 and comparator laboratory technology plasma viral load results were provided from 13 of the 19 eligible studies, which accounted for a total of 3790 paired data points. We used random effects models to determine the accuracy and misclassification at various treatment failure thresholds (detectable, 200, 400, 500, 600, 800 and 1000copies/ml). Results: Thirty percent of viral load test results were undetectable, while 45{\%} were between detectable and 10000copies/ml and the remaining 25{\%} were above 10000copies/ml. The median Xpert viral load was 119copies/ml and the median comparator viral load was 157copies/ml, while the log10 bias was 0.04 (0.02-0.07). The sensitivity and specificity to detect treatment failure were above 95{\%} at all treatment failure thresholds, except for detectable, at which the sensitivity was 93.33{\%} (95{\%} confidence interval: 88.2-96.3) and specificity was 80.56{\%} (95{\%} CI: 64.6-90.4). Conclusion: The Cepheid Xpert HIV-1 viral load plasma assay results were highly comparable to laboratory-based technologies with limited bias and high sensitivity and specificity to detect treatment failure. Alternative specimen types and technologies that enable decentralized testing services can be considered to expand access to viral load.",
author = "Sacks, {Jilian A.} and Youyi Fong and Gonzalez, {Mercedes Perez} and Mauro Andreotti and Shrikala Baliga and Nigel Garrett and Jeanne Jordan and Etienne Karita and Smita Kulkarni and Orna Mor and Fausta Mosha and Zibusiso Ndlovu and Plantier, {Jean Christophe} and Shanmugam Saravanan and Lesley Scott and Trevor Peter and Meg Doherty and Lara Vojnov",
year = "2019",
month = "10",
day = "1",
doi = "10.1097/QAD.0000000000002303",
language = "English",
volume = "33",
pages = "1881--1889",
journal = "AIDS",
issn = "0269-9370",
publisher = "Lippincott Williams and Wilkins",
number = "12",

}

Sacks, JA, Fong, Y, Gonzalez, MP, Andreotti, M, Baliga, S, Garrett, N, Jordan, J, Karita, E, Kulkarni, S, Mor, O, Mosha, F, Ndlovu, Z, Plantier, JC, Saravanan, S, Scott, L, Peter, T, Doherty, M & Vojnov, L 2019, 'Performance of Cepheid Xpert HIV-1 viral load plasma assay to accurately detect treatment failure', AIDS, vol. 33, no. 12, pp. 1881-1889. https://doi.org/10.1097/QAD.0000000000002303

Performance of Cepheid Xpert HIV-1 viral load plasma assay to accurately detect treatment failure. / Sacks, Jilian A.; Fong, Youyi; Gonzalez, Mercedes Perez; Andreotti, Mauro; Baliga, Shrikala; Garrett, Nigel; Jordan, Jeanne; Karita, Etienne; Kulkarni, Smita; Mor, Orna; Mosha, Fausta; Ndlovu, Zibusiso; Plantier, Jean Christophe; Saravanan, Shanmugam; Scott, Lesley; Peter, Trevor; Doherty, Meg; Vojnov, Lara.

In: AIDS, Vol. 33, No. 12, 01.10.2019, p. 1881-1889.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Performance of Cepheid Xpert HIV-1 viral load plasma assay to accurately detect treatment failure

AU - Sacks, Jilian A.

AU - Fong, Youyi

AU - Gonzalez, Mercedes Perez

AU - Andreotti, Mauro

AU - Baliga, Shrikala

AU - Garrett, Nigel

AU - Jordan, Jeanne

AU - Karita, Etienne

AU - Kulkarni, Smita

AU - Mor, Orna

AU - Mosha, Fausta

AU - Ndlovu, Zibusiso

AU - Plantier, Jean Christophe

AU - Saravanan, Shanmugam

AU - Scott, Lesley

AU - Peter, Trevor

AU - Doherty, Meg

AU - Vojnov, Lara

PY - 2019/10/1

Y1 - 2019/10/1

N2 - Background: Coverage of viral load testing remains low with only half of the patients in need having adequate access. Alternative technologies to high throughput centralized machines can be used to support viral load scale-up; however, clinical performance data are lacking. We conducted a meta-analysis comparing the Cepheid Xpert HIV-1 viral load plasma assay to traditional laboratory-based technologies. Methods: Cepheid Xpert HIV-1 and comparator laboratory technology plasma viral load results were provided from 13 of the 19 eligible studies, which accounted for a total of 3790 paired data points. We used random effects models to determine the accuracy and misclassification at various treatment failure thresholds (detectable, 200, 400, 500, 600, 800 and 1000copies/ml). Results: Thirty percent of viral load test results were undetectable, while 45% were between detectable and 10000copies/ml and the remaining 25% were above 10000copies/ml. The median Xpert viral load was 119copies/ml and the median comparator viral load was 157copies/ml, while the log10 bias was 0.04 (0.02-0.07). The sensitivity and specificity to detect treatment failure were above 95% at all treatment failure thresholds, except for detectable, at which the sensitivity was 93.33% (95% confidence interval: 88.2-96.3) and specificity was 80.56% (95% CI: 64.6-90.4). Conclusion: The Cepheid Xpert HIV-1 viral load plasma assay results were highly comparable to laboratory-based technologies with limited bias and high sensitivity and specificity to detect treatment failure. Alternative specimen types and technologies that enable decentralized testing services can be considered to expand access to viral load.

AB - Background: Coverage of viral load testing remains low with only half of the patients in need having adequate access. Alternative technologies to high throughput centralized machines can be used to support viral load scale-up; however, clinical performance data are lacking. We conducted a meta-analysis comparing the Cepheid Xpert HIV-1 viral load plasma assay to traditional laboratory-based technologies. Methods: Cepheid Xpert HIV-1 and comparator laboratory technology plasma viral load results were provided from 13 of the 19 eligible studies, which accounted for a total of 3790 paired data points. We used random effects models to determine the accuracy and misclassification at various treatment failure thresholds (detectable, 200, 400, 500, 600, 800 and 1000copies/ml). Results: Thirty percent of viral load test results were undetectable, while 45% were between detectable and 10000copies/ml and the remaining 25% were above 10000copies/ml. The median Xpert viral load was 119copies/ml and the median comparator viral load was 157copies/ml, while the log10 bias was 0.04 (0.02-0.07). The sensitivity and specificity to detect treatment failure were above 95% at all treatment failure thresholds, except for detectable, at which the sensitivity was 93.33% (95% confidence interval: 88.2-96.3) and specificity was 80.56% (95% CI: 64.6-90.4). Conclusion: The Cepheid Xpert HIV-1 viral load plasma assay results were highly comparable to laboratory-based technologies with limited bias and high sensitivity and specificity to detect treatment failure. Alternative specimen types and technologies that enable decentralized testing services can be considered to expand access to viral load.

UR - http://www.scopus.com/inward/record.url?scp=85071783702&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85071783702&partnerID=8YFLogxK

U2 - 10.1097/QAD.0000000000002303

DO - 10.1097/QAD.0000000000002303

M3 - Article

C2 - 31274537

AN - SCOPUS:85071783702

VL - 33

SP - 1881

EP - 1889

JO - AIDS

JF - AIDS

SN - 0269-9370

IS - 12

ER -