SurePath specimens versus ThinPrep specimen types on the COBAS 4800 platform: High-risk HPV status and cytology correlation in an ethnically diverse bronx population

Rizwan C. Naeem, D. Yitzchak Goldstein, Mark H. Einstein, G. Ramos Rivera, K. Schlesinger, Samer N. Khader, Mark J. Suhrland, Amy S. Fox

Research output: Contribution to journalArticle

3 Citations (Scopus)

Abstract

Objective: To compare the cytologic preparations of 130 cervical specimens (from women of various ethnicities at high risk for human papillomavirus [HPV] infection) using the SurePath (SP) collection system with specimens gathered using the ThinPrep (TP) system, as processed on the Cobas 4800 analyzer, to determine which collection method more accurately identifies HPV infection. Methods: In our prospective study, specimens were collected from 130 women of various ethnicities residing in or near Bronx County, NY. The SP-collected specimen was first processed for cytologic findings; if clinical HPV testing was requested on that specimen, it was tested using Hybrid Capture II (HC2) methodology. We tested the remnant SP-collected cell concentrate using the Cobas analyzer. Then, the TP-collected and SP-collected specimens were tested in the same run on that analyzer, and the results were compared. We also compared the results with the concurrent cytologic findings. Results: The results were concordant for overall HR-HPV status in 93.8% of cases. Also, a statistically significant lower cycle threshold value was observed with Cobas testing of specimen concentrates tested via the BD SurePath Pap Test (P ¼ .001), suggesting higher sensitivity compared with specimens tested via the ThinPrep Pap Test. Conclusion: Cobas 4800 HPV testing of SP-collected specimen concentrates yields comparable results to TP-collected specimen concentrates. Based on the limited data that we derived, SP collection may be a more favorable methodology than TP collection for HPV testing of individuals at high risk in our ethnically diverse, urban patient population.

Original languageEnglish (US)
Pages (from-to)207-213
Number of pages7
JournalLab Medicine
Volume48
Issue number3
DOIs
StatePublished - Aug 1 2017

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Cytology
Cell Biology
Testing
Population
Papanicolaou Test
Papillomavirus Infections
Urban Population
Prospective Studies

Keywords

  • Cobas 4800 HPV genotyping
  • HPV screening
  • HPV testing comparison
  • HPV testing in diverse population
  • NY State off-label LDT approval
  • SurePath
  • ThinPrep cytologic testing

ASJC Scopus subject areas

  • Clinical Biochemistry
  • Biochemistry, medical

Cite this

@article{d0f17e2fca70408c83377dc0c528c926,
title = "SurePath specimens versus ThinPrep specimen types on the COBAS 4800 platform: High-risk HPV status and cytology correlation in an ethnically diverse bronx population",
abstract = "Objective: To compare the cytologic preparations of 130 cervical specimens (from women of various ethnicities at high risk for human papillomavirus [HPV] infection) using the SurePath (SP) collection system with specimens gathered using the ThinPrep (TP) system, as processed on the Cobas 4800 analyzer, to determine which collection method more accurately identifies HPV infection. Methods: In our prospective study, specimens were collected from 130 women of various ethnicities residing in or near Bronx County, NY. The SP-collected specimen was first processed for cytologic findings; if clinical HPV testing was requested on that specimen, it was tested using Hybrid Capture II (HC2) methodology. We tested the remnant SP-collected cell concentrate using the Cobas analyzer. Then, the TP-collected and SP-collected specimens were tested in the same run on that analyzer, and the results were compared. We also compared the results with the concurrent cytologic findings. Results: The results were concordant for overall HR-HPV status in 93.8{\%} of cases. Also, a statistically significant lower cycle threshold value was observed with Cobas testing of specimen concentrates tested via the BD SurePath Pap Test (P ¼ .001), suggesting higher sensitivity compared with specimens tested via the ThinPrep Pap Test. Conclusion: Cobas 4800 HPV testing of SP-collected specimen concentrates yields comparable results to TP-collected specimen concentrates. Based on the limited data that we derived, SP collection may be a more favorable methodology than TP collection for HPV testing of individuals at high risk in our ethnically diverse, urban patient population.",
keywords = "Cobas 4800 HPV genotyping, HPV screening, HPV testing comparison, HPV testing in diverse population, NY State off-label LDT approval, SurePath, ThinPrep cytologic testing",
author = "Naeem, {Rizwan C.} and Goldstein, {D. Yitzchak} and Einstein, {Mark H.} and Rivera, {G. Ramos} and K. Schlesinger and Khader, {Samer N.} and Suhrland, {Mark J.} and Fox, {Amy S.}",
year = "2017",
month = "8",
day = "1",
doi = "10.1093/labmed/lmx019",
language = "English (US)",
volume = "48",
pages = "207--213",
journal = "Laboratory Medicine",
issn = "0007-5027",
publisher = "American Society of Clinical Pathologists",
number = "3",

}

TY - JOUR

T1 - SurePath specimens versus ThinPrep specimen types on the COBAS 4800 platform

T2 - High-risk HPV status and cytology correlation in an ethnically diverse bronx population

AU - Naeem, Rizwan C.

AU - Goldstein, D. Yitzchak

AU - Einstein, Mark H.

AU - Rivera, G. Ramos

AU - Schlesinger, K.

AU - Khader, Samer N.

AU - Suhrland, Mark J.

AU - Fox, Amy S.

PY - 2017/8/1

Y1 - 2017/8/1

N2 - Objective: To compare the cytologic preparations of 130 cervical specimens (from women of various ethnicities at high risk for human papillomavirus [HPV] infection) using the SurePath (SP) collection system with specimens gathered using the ThinPrep (TP) system, as processed on the Cobas 4800 analyzer, to determine which collection method more accurately identifies HPV infection. Methods: In our prospective study, specimens were collected from 130 women of various ethnicities residing in or near Bronx County, NY. The SP-collected specimen was first processed for cytologic findings; if clinical HPV testing was requested on that specimen, it was tested using Hybrid Capture II (HC2) methodology. We tested the remnant SP-collected cell concentrate using the Cobas analyzer. Then, the TP-collected and SP-collected specimens were tested in the same run on that analyzer, and the results were compared. We also compared the results with the concurrent cytologic findings. Results: The results were concordant for overall HR-HPV status in 93.8% of cases. Also, a statistically significant lower cycle threshold value was observed with Cobas testing of specimen concentrates tested via the BD SurePath Pap Test (P ¼ .001), suggesting higher sensitivity compared with specimens tested via the ThinPrep Pap Test. Conclusion: Cobas 4800 HPV testing of SP-collected specimen concentrates yields comparable results to TP-collected specimen concentrates. Based on the limited data that we derived, SP collection may be a more favorable methodology than TP collection for HPV testing of individuals at high risk in our ethnically diverse, urban patient population.

AB - Objective: To compare the cytologic preparations of 130 cervical specimens (from women of various ethnicities at high risk for human papillomavirus [HPV] infection) using the SurePath (SP) collection system with specimens gathered using the ThinPrep (TP) system, as processed on the Cobas 4800 analyzer, to determine which collection method more accurately identifies HPV infection. Methods: In our prospective study, specimens were collected from 130 women of various ethnicities residing in or near Bronx County, NY. The SP-collected specimen was first processed for cytologic findings; if clinical HPV testing was requested on that specimen, it was tested using Hybrid Capture II (HC2) methodology. We tested the remnant SP-collected cell concentrate using the Cobas analyzer. Then, the TP-collected and SP-collected specimens were tested in the same run on that analyzer, and the results were compared. We also compared the results with the concurrent cytologic findings. Results: The results were concordant for overall HR-HPV status in 93.8% of cases. Also, a statistically significant lower cycle threshold value was observed with Cobas testing of specimen concentrates tested via the BD SurePath Pap Test (P ¼ .001), suggesting higher sensitivity compared with specimens tested via the ThinPrep Pap Test. Conclusion: Cobas 4800 HPV testing of SP-collected specimen concentrates yields comparable results to TP-collected specimen concentrates. Based on the limited data that we derived, SP collection may be a more favorable methodology than TP collection for HPV testing of individuals at high risk in our ethnically diverse, urban patient population.

KW - Cobas 4800 HPV genotyping

KW - HPV screening

KW - HPV testing comparison

KW - HPV testing in diverse population

KW - NY State off-label LDT approval

KW - SurePath

KW - ThinPrep cytologic testing

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U2 - 10.1093/labmed/lmx019

DO - 10.1093/labmed/lmx019

M3 - Article

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AN - SCOPUS:85029300920

VL - 48

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EP - 213

JO - Laboratory Medicine

JF - Laboratory Medicine

SN - 0007-5027

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