Clinical performance of the Roche Cobas 4800 HPV test for primary cervical cancer screening in a Chinese population

Liu, Stephanie S; Chan, Karen Kar Loen; Wei, Tina N; Tse, Ka Yu; Ngu, Siew Fei; Chu, Mandy Man Yee; Lau, Lesley S. K.; Cheung, Annie N. Y.; Ngan, Hextan Y. S.

doi:10.1371/journal.pone.0272721

Cited by 5 publications

(11 citation statements)

References 36 publications

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“…However, COBAS 4800 showed greater congruence of positive results with severe lesions (COBAS 4800: 67.33% and 65.94%; HC2: 46.41% and 44.62%). Therefore, COBAS 4800 demonstrated a better specificity than HC2 in dealing with CIN 2+ and CIN 3+ cases; on the other hand, HC2 tests tend to have a moderately better sensitivity [23].…”

Section: Application Of Hpv Detection Methodsmentioning

confidence: 91%

“…From various cytology groups researching the HPV prevalence, two tests had no remarkable difference in testing HR-HPVs, but they appeared in females without HPV infection. Through the study focusing on HC2 and COBAS 4800 tests in various histology conditions, the overall agreement on test results between the two methods was 74.30% [23]. The remarkable discrepancy did not happen in testing CIN 2+ and CIN 3+ but in females with normal or low-grade HPV infection.…”

Section: Application Of Hpv Detection Methodsmentioning

confidence: 92%

“…Both methods are suitable for cervical disease diagnosis in that there was no significant divergence in diagnosing HR-HPV infections. Besides, the investigation suggested that co-testing is essential for the primary detection of HPV infection, which ensures a more accurate testing result [23]. Also, most detection assays tended to have lower concordance with normal or low-grade lesion cases.…”

Section: Discussionmentioning

confidence: 99%

“…To make a more comprehensive view of the advantage and disadvantages of each detection method, the validation study needs to be done in a larger population. Also, the working efficiency of each method was not added to the consideration [23].…”

Section: Discussionmentioning

confidence: 99%

“…concordance analysis between COBAS 4800 and HC2 positive results associated with specific (adapted from Liu et al 2022)[23] …”

mentioning

confidence: 99%

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HPV Infection and Detection

Zhang¹

2022

HSET

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Human papillomavirus (HPV) can be transmitted by sexual activity and direct skin-to-skin contact. The virus accounts for more than 90% of cervical cancer cases. Target amplification and signal amplification are two detection methods for HPV diagnosis. COBAS 4800 and the Hybrid Capture (HC2) system are two examples of target amplification and signal amplification techniques, respectively. According to the cohort study done in Hong Kong, detection assays have better concordance with samples in the more severe lesion. While COBAS 4800 has greater specificity in targeting high-grade lesions, HC2 has better sensitivity. This review aims to discuss HPV infection, and detection techniques and point out possible improvements.

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Section: Application Of Hpv Detection Methodsmentioning

confidence: 91%

Section: Application Of Hpv Detection Methodsmentioning

confidence: 92%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

“…concordance analysis between COBAS 4800 and HC2 positive results associated with specific (adapted from Liu et al 2022)[23] …”

mentioning

confidence: 99%

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HPV Infection and Detection

Zhang¹

2022

HSET

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Multiplex recombinase polymerase amplification for high-risk and low-risk type HPV detection, as potential local use in single tube

Wongsamart

Bhattarakasol

Chaiwongkot

et al. 2023

Sci Rep

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High rates of new cervical cancer cases and deaths occur in low- and middle-income countries yearly, and one reason was found related to limitation of regular cervical cancer screening in local and low-resource settings. HPV has over 150 types, yet certain 14–20 high-risk and 13–14 low-risk types are common, and, thus, most conventional HPV nucleic acid assays, for examples, Cobas 4800 HPV test (Roche Diagnostics, New Jersey, USA) and REBA HPV-ID (Molecules and Diagnostics, Wonju, Republic of Korea) were developed to cover these types. We thereby utilized bioinformatics combined with recent isothermal amplification technique at 35–42 °C to firstly describe multiplex recombinase polymerase amplification assay that is specific to these common 20 high-risk and 14 low-risk types, and also L1 and E6/E7 genes that target different stages of cervical cancer development. Multiplex primer concentrations and reaction incubation conditions were optimized to allow simultaneous two gene detections at limit of detection of 1000 copies (equivalent to 2.01 fg) for L1 and 100 copies (0.0125 fg) for E6/E7, respectively. The assay was validated against urogenital and other pathogens, normal flora, and human control. In 130 real clinical sample tests, the assay demonstrated 100% specificity, 78% diagnostic accuracy, and 75% sensitivity compared with REBA HPV-ID test, and is much more rapid (15–40 min), less expensive (~ 3–4 USD/reaction) and does not require instrumentation (35–42 °C reaction condition so hand holding or tropical temperature is possible). Hence, the developed novel assay provides alternative screening tool for potential local screening. Furthermore, as this assay uses safe chemical reagents, it is safe for users.

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Urinary high-risk HPV DNA detection to enhance cervical cancer screening in developing countries

Intan,

Utama,

Wulandari

et al. 2023

Preprint

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Background More than half of the predicted cervical cancer deaths are expected to be prevented with improved screening and management strategies. However, the conventional cervical screening procedure is considered as uncomfortable and embarrassing for most women in developing countries, such as Indonesia, leading to a low participation rate of screening. In response, we assessed the performance of the newly developed hrHPV ReadyMix qPCR Kit to detect high-risk human papillomavirus (HPV) in urine samples and conduct simultaneous genotyping of HPV16, HPV18, and HPV52. Methods We enrolled women aged 20-50 years from three cities in Indonesia, specifically Jakarta, Bandung, and Semarang. Participants were instructed to provide self-collected first-void urine samples, followed by a physician-assisted cervical swab sample collection. Nucleic acids were then extracted and tested for HPV with Roche cobas 6800 HPV and hrHPV ReadyMix qPCR kit. Next generation-sequencing (NGS) was employed in cases of discrepant results. hrHPV ReadyMix diagnostics accuracy were assessed against Roche cobas 6800 HPV as a reference test and the utility of urine samples as an alternative sampling method were compared to the standard cervical swab samples. Results 876 paired samples were analysed for HPV detection. The sensitivity of HPV detection in cervical swabs using hrHPV ReadyMix qPCR Kit reached 96.55% and the specificity reached 99.87%. Despite having a tendency to produce higher Ct value in high-risk HPV detection, urine samples produced a high sensitivity at 80.88% and a specificity of 100.00% when compared to cervical swabs. Our developed method enables population-based high-risk HPV analysis with 6.62% HPV prevalence based on cervical swabs and 6.28% HPV prevalence based on urine samples. Urine samples, tested with the hrHPV ReadyMix qPCR Kit, exhibited comparable HPV positivity rate to cervical swabs and similar genotyping capability of HPV16 and HPV18 as the Roche cobas 6800 HPV system. Conclusions We demonstrated that self-collected urine samples can be an alternative specimen to detect HPV infection with a diagnostic accuracy of 98.48%. This study highlights the potential of the hrHPV ReadyMix qPCR Kit in improving cervical cancer screening and provides valuable insights for future interventions.

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Clinical performance of the Roche Cobas 4800 HPV test for primary cervical cancer screening in a Chinese population

Cited by 5 publications

References 36 publications

HPV Infection and Detection

HPV Infection and Detection

Multiplex recombinase polymerase amplification for high-risk and low-risk type HPV detection, as potential local use in single tube

Urinary high-risk HPV DNA detection to enhance cervical cancer screening in developing countries

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