Limitations of widely used high-risk human papillomavirus laboratory-developed testing in cervical cancer screening.

Naryshkin, Sonya and Austin, R Marshall (2012) Limitations of widely used high-risk human papillomavirus laboratory-developed testing in cervical cancer screening. Drug Healthc Patient Saf, 4. 167 - 172.

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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.

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Details

Item Type:	Article
Status:	Published
Creators/Authors:	Creators Email Pitt Username ORCID Naryshkin, Sonya Austin, R Marshall rma10@pitt.edu RMA10
Date:	2012
Date Type:	Publication
Journal or Publication Title:	Drug Healthc Patient Saf
Volume:	4
Page Range:	167 - 172
DOI or Unique Handle:	10.2147/dhps.s37273
Schools and Programs:	School of Medicine > Pathology
Refereed:	Yes
Uncontrolled Keywords:	HPV, Hybrid Capture 2, LDT, SurePath, cervical screening
Date Deposited:	03 Dec 2012 22:29
Last Modified:	05 Dec 2017 17:01
URI:	http://d-scholarship.pitt.edu/id/eprint/16700

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