Comparison of the AmpFire® Multiplex HPV Assay to the Xpert® HPV Assay for detection of human papillomavirus and cervical disease in women with human immunodeficiency virus: a pragmatic performance evaluation

Sikhulile Moyo^#^{1

2}, Doreen Ramogola-Masire^#³, Natasha O Moraka¹, Leabaneng Tawe³, Farzad Noubary⁴, Kesego Motsumi¹, Godiraone Manowe¹, Boitumelo Zuze¹, Botshelo Radibe¹, Faith T T Hungwe^{5

6

7}, Terence Mohammed¹, Comfort Maphorisa¹, Roger Shapiro^{2

8

9}, Simani Gaseitsiwe^{1

2}, Rebecca Luckett^{10

11

12

13}

Affiliations

¹ Botswana Harvard Health Partnership, Gaborone, Botswana.
² Harvard T.H. Chan School of Public Health, Boston, MA, USA.
³ Faculty of Medicine, University of Botswana, Gaborone, Botswana.
⁴ Department of Health Sciences, Northeastern University, Boston, MA, USA.
⁵ School of Engineering Sciences in Chemistry, Biotechnology and Health, KTH Royal Institute of Technology, Stockholm, Sweden.
⁶ Department of Molecular Medicine, Karolinska Institute, Stockholm, Sweden.
⁷ Department of Biochemistry and Chemistry, Stockholm University, Stockholm, Sweden.
⁸ Department of Obstetrics and Gynecology, Beth Israel Deaconess Medical Center, Kirstein, 3Rd Floor, 330 Brookline Avenue, Boston, MA, 02215, USA.
⁹ Harvard Medical School, Boston, MA, USA.
¹⁰ Botswana Harvard Health Partnership, Gaborone, Botswana. rluckett@bidmc.harvard.edu.
¹¹ Faculty of Medicine, University of Botswana, Gaborone, Botswana. rluckett@bidmc.harvard.edu.
¹² Department of Obstetrics and Gynecology, Beth Israel Deaconess Medical Center, Kirstein, 3Rd Floor, 330 Brookline Avenue, Boston, MA, 02215, USA. rluckett@bidmc.harvard.edu.
¹³ Harvard Medical School, Boston, MA, USA. rluckett@bidmc.harvard.edu.

^# Contributed equally.

PMID: 37165397
PMCID: PMC10170707
DOI: 10.1186/s13027-023-00504-z

Comparison of the AmpFire® Multiplex HPV Assay to the Xpert® HPV Assay for detection of human papillomavirus and cervical disease in women with human immunodeficiency virus: a pragmatic performance evaluation

Sikhulile Moyo et al. Infect Agent Cancer. 2023.

. 2023 May 10;18(1):29.

doi: 10.1186/s13027-023-00504-z.

Authors

Affiliations

¹ Botswana Harvard Health Partnership, Gaborone, Botswana.
² Harvard T.H. Chan School of Public Health, Boston, MA, USA.
³ Faculty of Medicine, University of Botswana, Gaborone, Botswana.
⁴ Department of Health Sciences, Northeastern University, Boston, MA, USA.
⁵ School of Engineering Sciences in Chemistry, Biotechnology and Health, KTH Royal Institute of Technology, Stockholm, Sweden.
⁶ Department of Molecular Medicine, Karolinska Institute, Stockholm, Sweden.
⁷ Department of Biochemistry and Chemistry, Stockholm University, Stockholm, Sweden.
⁸ Department of Obstetrics and Gynecology, Beth Israel Deaconess Medical Center, Kirstein, 3Rd Floor, 330 Brookline Avenue, Boston, MA, 02215, USA.
⁹ Harvard Medical School, Boston, MA, USA.
¹⁰ Botswana Harvard Health Partnership, Gaborone, Botswana. rluckett@bidmc.harvard.edu.
¹¹ Faculty of Medicine, University of Botswana, Gaborone, Botswana. rluckett@bidmc.harvard.edu.
¹² Department of Obstetrics and Gynecology, Beth Israel Deaconess Medical Center, Kirstein, 3Rd Floor, 330 Brookline Avenue, Boston, MA, 02215, USA. rluckett@bidmc.harvard.edu.
¹³ Harvard Medical School, Boston, MA, USA. rluckett@bidmc.harvard.edu.

^# Contributed equally.

PMID: 37165397
PMCID: PMC10170707
DOI: 10.1186/s13027-023-00504-z

Abstract

Background: Low- and middle-income countries (LMICs) account for nearly 85% of the global cervical cancer burden, yet have the least access to high-performance screening. International guidelines recommend human papillomavirus testing (HPV) as primary screening, yet implementation is inhibited by the cost of HPV testing. Atila AmpFire® HPV Assay (AmpFire) is both affordable and easy to use, and offers individual genotyping. The objective of this study was to compare the performance of the AmpFire HPV assay to the Xpert® HPV assay in detection of both HPV and clinically significant cervical disease.

Methods: We utilized stored cervical specimens from a prospective cohort study of women living with human immunodeficiency virus (HIV) in Botswana conducted from May to July 2018. Positive and negative percent agreement was calculated for the AmpFire and Xpert assays, as was detection of high-grade cervical dysplasia.

Results: 63 stored cervical specimens had detectable DNA after thawing and were included in the analysis. The positive percent agreement was 91.2% (95%CI 76.3-98.1) and negative percent agreement was 79.3% (95% CI 60.3-92.0). Six cases positive by AmpFire but negative by Xpert were HPV genotypes 35, 52 (n = 2), 58, 68, and co-infection with HPV 45 and 68. Both Xpert and AmpFire assays detected HPV in all 10 samples of women who had high-grade cervical dysplasia.

Conclusions: The AmpFire HPV assay demonstrated excellent analytic performance in both detection of HPV and clinically significant cervical disease. AmpFire HPV is a promising option to increase access to affordable, type-specific HPV screening for cervical cancer in LMICs.

Keywords: AmpFire; Cervical high-grade dysplasia; Cervical precancer; Cervical screening; Human immunodeficiency virus (HIV); Human papillomavirus (HPV); Validation; Xpert.

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Conflict of interest statement

The authors declare that they have no competing interests.

Update of

Comparison of the AmpFire Multiplex HPV Assay to the Xpert HPV Assay for detection of human papillomavirus and cervical disease in women with human immunodeficiency virus: A pragmatic performance evaluation.
Moyo S, Ramogola-Masire D, Moraka N, Tawe L, Noubary F, Motsumi K, Manowe G, Zuze B, Radibe B, Hungwe FT, Mohammed T, Maphorisa C, Shapiro R, Gaseitsiwe S, Luckett R. Moyo S, et al. Res Sq [Preprint]. 2023 Mar 2:rs.3.rs-2606441. doi: 10.21203/rs.3.rs-2606441/v1. Res Sq. 2023. Update in: Infect Agent Cancer. 2023 May 10;18(1):29. doi: 10.1186/s13027-023-00504-z. PMID: 36909533 Free PMC article. Updated. Preprint.

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Comparison of the AmpFire® Multiplex HPV Assay to the Xpert® HPV Assay for detection of human papillomavirus and cervical disease in women with human immunodeficiency virus: a pragmatic performance evaluation

Affiliations

Comparison of the AmpFire® Multiplex HPV Assay to the Xpert® HPV Assay for detection of human papillomavirus and cervical disease in women with human immunodeficiency virus: a pragmatic performance evaluation

Authors

Affiliations

Abstract

Conflict of interest statement

Update of

References

Grants and funding

LinkOut - more resources

Full Text Sources