Clinical Performance of Cobas 6800 for the Detection of High-Risk Human Papillomavirus in Urine Samples
Testing for high-risk human papillomavirus (HPV) as part of primary cervical cancer screening has become more common recently. The Cobas 6800, an FDA-approved cervical screening platform, detects 14 high-risk HPVs, including HPV16 and HPV18. However, this test is limited to only women, which leads t...
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| Format: | Article |
| Language: | English |
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MDPI AG
2023-06-01
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| Series: | Vaccines |
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| Online Access: | https://www.mdpi.com/2076-393X/11/6/1071 |
| _version_ | 1797592446933139456 |
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| author | Brian Joseph Hajjar Ummar Raheel Rachel Manina Jovanie Simpson Muhammad Irfan Yasir Waheed |
| author_facet | Brian Joseph Hajjar Ummar Raheel Rachel Manina Jovanie Simpson Muhammad Irfan Yasir Waheed |
| author_sort | Brian Joseph Hajjar |
| collection | DOAJ |
| description | Testing for high-risk human papillomavirus (HPV) as part of primary cervical cancer screening has become more common recently. The Cobas 6800, an FDA-approved cervical screening platform, detects 14 high-risk HPVs, including HPV16 and HPV18. However, this test is limited to only women, which leads to low screening rates in trans men and other non-binary people. The cervical screening of trans men and other genders, especially those lying on the female-to-male spectrum, is equally important. Furthermore, cisgender males, particularly homosexuals, are also prone to chronic HPV infections and serve as HPV carriers, transmitting it to women and other men through sexual contact. Another limitation of the test is its invasive specimen collection, which induces discomfort and genital dysphoria. Therefore, there is a need for an innovative, less invasive method that would allow the sampling process to be more comfortable. In this study, we assess the performance of the Cobas 6800 for high-risk HPV detection in urine samples spiked with HPV16, HPV18, and HPV68. The limit of detection (LOD) was calculated using a dilution series (1.25–10,000 copies/mL) over a course of three days. Furthermore, the clinical validation was performed by calculating sensitivity, specificity, and accuracy. The limit of detection ranged from 50–1000 copies/mL depending upon the genotype. Moreover, the urine test demonstrated a high clinical sensitivity of 93%, 94%, and 90% for HPV16, HPV18, and HPV68, with 100% specificity. The overall percent agreement was calculated to be 95% for both HPV16 and HPV18, and 93% for HPV68. The high concordance, reproducibility, and clinical performance of the current assay suggest that the urine-based HPV test fulfills the requirements for its use in primary cervical screening. Moreover, it has the potential to be used for mass screening to not only identify high-risk individuals, but also to monitor vaccine effectiveness. |
| first_indexed | 2024-03-11T01:51:08Z |
| format | Article |
| id | doaj.art-818e05a545db49ab924cdb3ac6e4fd54 |
| institution | Directory Open Access Journal |
| issn | 2076-393X |
| language | English |
| last_indexed | 2024-03-11T01:51:08Z |
| publishDate | 2023-06-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Vaccines |
| spelling | doaj.art-818e05a545db49ab924cdb3ac6e4fd542023-11-18T12:58:49ZengMDPI AGVaccines2076-393X2023-06-01116107110.3390/vaccines11061071Clinical Performance of Cobas 6800 for the Detection of High-Risk Human Papillomavirus in Urine SamplesBrian Joseph Hajjar0Ummar Raheel1Rachel Manina2Jovanie Simpson3Muhammad Irfan4Yasir Waheed5Telostrand Innovations LLC, Hackensack, NJ 07601, USATelostrand Innovations LLC, Hackensack, NJ 07601, USATelostrand Innovations LLC, Hackensack, NJ 07601, USATelostrand Innovations LLC, Hackensack, NJ 07601, USATelostrand Innovations LLC, Hackensack, NJ 07601, USAOffice of Research, Innovation & Commercialization, Shaheed Zulfiqar Ali Bhutto Medical University (SZABMU), Islamabad 44000, PakistanTesting for high-risk human papillomavirus (HPV) as part of primary cervical cancer screening has become more common recently. The Cobas 6800, an FDA-approved cervical screening platform, detects 14 high-risk HPVs, including HPV16 and HPV18. However, this test is limited to only women, which leads to low screening rates in trans men and other non-binary people. The cervical screening of trans men and other genders, especially those lying on the female-to-male spectrum, is equally important. Furthermore, cisgender males, particularly homosexuals, are also prone to chronic HPV infections and serve as HPV carriers, transmitting it to women and other men through sexual contact. Another limitation of the test is its invasive specimen collection, which induces discomfort and genital dysphoria. Therefore, there is a need for an innovative, less invasive method that would allow the sampling process to be more comfortable. In this study, we assess the performance of the Cobas 6800 for high-risk HPV detection in urine samples spiked with HPV16, HPV18, and HPV68. The limit of detection (LOD) was calculated using a dilution series (1.25–10,000 copies/mL) over a course of three days. Furthermore, the clinical validation was performed by calculating sensitivity, specificity, and accuracy. The limit of detection ranged from 50–1000 copies/mL depending upon the genotype. Moreover, the urine test demonstrated a high clinical sensitivity of 93%, 94%, and 90% for HPV16, HPV18, and HPV68, with 100% specificity. The overall percent agreement was calculated to be 95% for both HPV16 and HPV18, and 93% for HPV68. The high concordance, reproducibility, and clinical performance of the current assay suggest that the urine-based HPV test fulfills the requirements for its use in primary cervical screening. Moreover, it has the potential to be used for mass screening to not only identify high-risk individuals, but also to monitor vaccine effectiveness.https://www.mdpi.com/2076-393X/11/6/1071HPVcervical cancerCobas 6800urine testinggender-neutral screening |
| spellingShingle | Brian Joseph Hajjar Ummar Raheel Rachel Manina Jovanie Simpson Muhammad Irfan Yasir Waheed Clinical Performance of Cobas 6800 for the Detection of High-Risk Human Papillomavirus in Urine Samples Vaccines HPV cervical cancer Cobas 6800 urine testing gender-neutral screening |
| title | Clinical Performance of Cobas 6800 for the Detection of High-Risk Human Papillomavirus in Urine Samples |
| title_full | Clinical Performance of Cobas 6800 for the Detection of High-Risk Human Papillomavirus in Urine Samples |
| title_fullStr | Clinical Performance of Cobas 6800 for the Detection of High-Risk Human Papillomavirus in Urine Samples |
| title_full_unstemmed | Clinical Performance of Cobas 6800 for the Detection of High-Risk Human Papillomavirus in Urine Samples |
| title_short | Clinical Performance of Cobas 6800 for the Detection of High-Risk Human Papillomavirus in Urine Samples |
| title_sort | clinical performance of cobas 6800 for the detection of high risk human papillomavirus in urine samples |
| topic | HPV cervical cancer Cobas 6800 urine testing gender-neutral screening |
| url | https://www.mdpi.com/2076-393X/11/6/1071 |
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