Clinical Validation of the cobas 4800 HPV Test for Cervical ... | 合法醫療器材資訊網

由DAMHeideman著作·2011·被引用162次—Sensitivityandspecificityvaluesofthecobas4800HPVtestforCIN2+were90%(54/60specimens;95%CI,82.4to97.6)and94.6%(95%CI,93.0to96.2), ...

Abstract

This study shows that the clinical performance and reproducibility of the cobas 4800 HPV test for high-risk human papillomavirus (HPV) detection fulfill the criteria as formulated in international guidelines of HPV test requirements for cervical screening purposes. Accordingly, the cobas 4800 HPV test can be considered clinically validated for cervical screening.

TEXT

A critical feature for high-risk human papillomavirus (hrHPV) tests used for cervical screening is their clinical accuracy for detection of high-grade cervical intraepithelial neoplasia (CIN) and cervical cancer (CIN2+). For primary screening, an hrHPV test should have a balanced clinical sensitivity and specificity to allow effective detection of CIN2+ and minimize follow-up procedures of HPV test-positive women without CIN2+. F...

The cobas® HPV Test | 合法醫療器材資訊網

The cobas® HPV Test is indicated for use for routine cervical cancer screening as per professional medical guidelines, including triage of ASC-US cytology, co- ... Read More

Roche's cobas HPV Test receives FDA approval for first | 合法醫療器材資訊網

The Roche test is now the only Human Papillomavirus (HPV) test approved for use as a primary (first-line) screening test with both SurePath and ThinPrep ... Read More

Roche receives FDA approval for cobas HPV test for use on ... | 合法醫療器材資訊網

2020年4月21日 — The cobas HPV test identifies women at risk for cervical cancer by detecting the presence of high-risk human papillomavirus (HPV) DNA in ... Read More

cobas® HPV Test | 合法醫療器材資訊網

The cobas® HPV Test is a qualitative in vitro test for the detection of Human Papillomavirus in cervical specimens collected by a clinician using an endocervical ... Read More

Roche receives FDA approval for cobas HPV test for ... | 合法醫療器材資訊網

2020年4月21日 — The cobas® HPV test identifies women at risk for cervical cancer by detecting the presence of high-risk human papillomavirus (HPV) DNA in ... Read More

Clinical Performance of Roche Cobas 4800 HPV Test | 合法醫療器材資訊網

由 M Cui 著作 · 2014 · 被引用 45 次 — The Roche Cobas 4800 HPV test (Cobas) is a novel molecular method based on real-time PCR (RT-PCR) (6, 7), with a fully automated system allowing quick ... Read More

Comparison of the cobas Human Papillomavirus (HPV) Test ... | 合法醫療器材資訊網

由 JC Gage 著作 · 2012 · 被引用 47 次 — The cobas HPV test (cobas; Roche Molecular Systems, Pleasanton, CA) was recently approved by the U.S. Food and Drug Administration (FDA) and identifies ... Read More

Analytic and Clinical Performance of cobas HPV Testing in ... | 合法醫療器材資訊網

由 N Wentzensen 著作 · 2014 · 被引用 28 次 — We demonstrate that cobas can be used for HPV detection in anal cytology specimens. Additional tests are necessary to identify men at the highest risk of anal ... Read More

Clinical Validation of the cobas 4800 HPV Test for Cervical ... | 合法醫療器材資訊網

由 DAM Heideman 著作 · 2011 · 被引用 162 次 — Sensitivity and specificity values of the cobas 4800 HPV test for CIN2+ were 90% (54/60 specimens; 95% CI, 82.4 to 97.6) and 94.6% (95% CI, 93.0 to 96.2), ... Read More

Clinical Validation of the cobas HPV Test on the cobas 6800 ... | 合法醫療器材資訊網

由 M Saville 著作 · 被引用 18 次 — The cobas HPV test detected over 98% of histologically confirmed cervical intraepithelial neoplasia grade 2+ (CIN2+) lesions in women age 30 years or older, ... Read More

相關資訊整理

The cobas® HPV Test | 合法醫療器材資訊網

Roche&#39;s cobas HPV Test receives FDA approval for first | 合法醫療器材資訊網

Roche receives FDA approval for cobas HPV test for use on ... | 合法醫療器材資訊網

cobas® HPV Test | 合法醫療器材資訊網

Roche receives FDA approval for cobas HPV test for ... | 合法醫療器材資訊網

Clinical Performance of Roche Cobas 4800 HPV Test | 合法醫療器材資訊網

Comparison of the cobas Human Papillomavirus (HPV) Test ... | 合法醫療器材資訊網

Analytic and Clinical Performance of cobas HPV Testing in ... | 合法醫療器材資訊網

Clinical Validation of the cobas 4800 HPV Test for Cervical ... | 合法醫療器材資訊網

Clinical Validation of the cobas HPV Test on the cobas 6800 ... | 合法醫療器材資訊網

Roche's cobas HPV Test receives FDA approval for first | 合法醫療器材資訊網