Limitations of Widely Used High-risk Human Papillomavirus Laboratory-developed Testing in Cervical Cancer Screening

Overview

Journal Drug Healthc Patient Saf

Publisher Dove Medical Press

Specialty Health Services

Date 2012 Nov 16

PMID 23152707

Citations 11

Authors

Sonya Naryshkin

R Marshall Austin

Affiliations

Soon will be listed here.

Abstract

Objective: To increase awareness of the limitations of high-risk human papillomavirus (hrHPV) laboratory-developed testing (LDT) widely used in US cervical cancer screening.

Methods And Results: A young woman in her 30s was diagnosed and treated for stage 1B1 cervical squamous cell carcinoma in which HPV 16 DNA was detected using polymerase chain reaction testing. Both 1 month before and 42 months before cervical cancer diagnosis, the patient had highly abnormal cytology findings; however, residual SurePath™ (Becton, Dickson and Company, Franklin Lakes, NJ) vial fluid yielded negative Hybrid Capture 2 (HC2; Qiagen NV, Hilden, Germany) hrHPV LDT results from each of the two specimens. This prompted questions to be asked concerning the performance characteristics of hrHPV LDT. A review of the available data indicates that (1) purification of DNA from SurePath specimens requires complex sample preparation due to formaldehyde crosslinking of proteins and nucleic acids, (2) HC2-SurePath hrHPV testing had not been Food and Drug Administration-approved after multiple premarket approval submissions, (3) detectible hrHPV DNA in the SurePath vial decreases over time, and (4) US laboratories performing HC2-SurePath hrHPV LDT testing are not using a standardized manufacturer-endorsed procedure.

Conclusion: Recently updated cervical screening guidelines in the US recommend against the use of hrHPV LDT in cervical screening, including widely used HC2 testing from the SurePath vial. The manufacturer recently issued a technical bulletin specifically warning that use of SurePath samples with the HC2 hrHPV test may provide false negative results and potentially compromise patient safety. Co-collection using a Food and Drug Administration-approved hrHPV test medium is recommended for HPV testing of patients undergoing cervical screening using SurePath samples.

Citing Articles

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Metabolomic Laboratory-Developed Tests: Current Status and Perspectives.

Lichtenberg S, Trifonova O, Maslov D, Balashova E, Lokhov P Metabolites. 2021; 11(7).

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Correlation between Human Papillomavirus Codetection Profiles and Cervical Intraepithelial Neoplasia in Japanese Women.

Okayama K, Kimura H, Teruya K, Ishii Y, Fujita K, Fujii M Microorganisms. 2020; 8(12).

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Prevalence of high-risk human papilloma virus in women with high-grade squamous cell intraepithelial lesions in Botswana using Abbott RealTime HPV assay.

Rantshabeng P, Kasvosve I, Ndlovu A, Gaseitsiwe S, Moyo S PLoS One. 2019; 14(1):e0211260.

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Detection of cervical precancerous lesions with Aptima HPV assays using SurePath preservative fluid specimens.

Chernesky M, Jang D, Escott N, Gilchrist J, Li J, Elit L Papillomavirus Res. 2017; 3:155-159.

PMID: 28720450 PMC: 5883188. DOI: 10.1016/j.pvr.2017.04.005.

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