The test utilizes amplification of target dna by the polymerase chain reaction pcr and nucleic acid hybridization for the detection of 14 highrisk hpv types in a single analysis. The fully automated cobas 4800 system is comprised of the cobas x 480 instrument and the cobas z 480 analyzer. Women who test positive for hpv genotypes 16 andor 18 by the cobas hpv test should be referred to colposcopy. Intended use of the cobas hpv test cervical screening.
The dashed arrows represent cutoff values for positive results, and were determined to be 40. Wright tc jr, stoler mh, sharma a, zhang g, behrens cm, wright tl. The cobas human papillomavirus hpv test, approved by the fda in april 2011, is a fully automated assay for the detection of 14 highrisk hr hpv genotypes from cervical specimens collected in liquidbased cytology medium using realtime pcr amplification of the l1 gene and taqman probes. This proprietary algorithm is based upon 15 years of proven clinical experience and eliminates the need for manual interpretations.
Cin2 and cervical cancer to provide clinically meaningful results in cervical cancer screening. The hybrid capture 2 hc2 and cobas hpv tests showed high agreement for cervical samples 94. Development and characterization of the cobas human. Comparison of the cobas human papillomavirus hpv test. Access package inserts through your countrys roche diagnostics website. The cobas hpv test allows you to manage your patients with greater precision and efficiency by individually identifying the highestrisk genotypes, hpv 16 and hpv 18, while simultaneously providing pooled results for 12 other hrhpv genotypes. Testing and genotyping of highrisk human papillomavirus. The test utilizes amplification of target dna by the polymerase chain reaction and nucleic acid hybridization for the detection of 14 highrisk hpv types in a. Please use one of the following formats to cite this article in your essay, paper or report.
Positive results should be confirmed with additional studies as clinically indicated. Comparison of the cobas human papillomavirus hpv test with. This website contains information on products which to targeted to a wide range of audiences and could contain product details or information otherwise. The cobas hpv test is based on two major processes. The abbott realti m e highrisk hpv assay is designed for the detection of highrisk hpv genotypes in cervical specimens from women with precancerous lesions of the cervix uteri. Aptima hpv assay panther system 100 and 250 test tigris dts system 250 test. Development and validation of a preanalytic procedure for.
A total of 208 specimens were tested with both tests, and those with discordant results were tested with the cobas hpv test roche diagnostics, indianapolis, in. Comparison of the aptima and cervista tests for detection of. Comparison of the aptima and cervista tests for detection. The cobas hpv test and the hc2 test detected hrhpv genotypes in a similar number of cervical samples 63260 46. The test utilizes amplification of target dna by the polymerase chain reaction and. Roche, as global leader in diagnostics, is pioneering this shift in the healthcare landscape. Comparison of cobas human papillomavirus test results from. Significantly enhances risk stratification lets you. Roche diagnostics products and solutions 2017 products and solutions 2017 roche diagnostics. The oldest hpv test on the market, hc2 qiagen only detects thirteen. Supporting documents older than three years cobas ampliscreen hbv test.
A comparison of the roche cobas hpv test with the hybrid. The cobas hpv test runs on the advanced cobas 4800 system, which requires minimal maintenance and eliminates many manual steps for maximum lab efficiency. The document revision information section is located at the end of this document. The cobas human papillomavirus hpv test, approved by the fda in april. Research paper comparison of the cobas 4800 hpv test and the. The causal relationship between human papillomavirus hpv and cervical cancer and its precursors has been well established. Hpv testing by cobas hpv test in a population from catalonia article pdf available in plos one 83. Food and drug administration fda and identifies hpv16 and hpv18 separately as well as detecting a pool of 11 hrhpv genotypes hpv31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 68 and also hpv66.
The cobas 4800 hpv test is a qualitative assay for the presence of hpv 16, hpv 18 and a pool of 12 other hrhpv genotypes 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. In addition, healthcare professionals should use the cobas hpv test results together combined other information, such as the patient screening history and risk factors. Highrisk human papillomavirus testing in women with ascus cytology. Defined egfr mutations are detected using dna isolated from formalinfixed paraffinembedded tumor tissue ffpet or circulatingfree. The accurate detection and typing of highrisk human papillomavirus hpv are critical for cervical cancer screening. Refer to the respective manufacturers package inserts for instructions for using preservcyt solution for collection, transport, storage, and. 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 brushspatula and placed in the thinprep pap test preservcyt solution. Learn about cobas hpv test and how it provides immediate risk. The cobas 4800 hpv test is a valuable but imperfect screening test for hpvrelated cancer and its precursors. Findings must be correlated with history and other test results.
Hpv testing after cytology can significantly improve workflow and reduce unnecessary aliquoting when a reflex hpv test for abnormal cytology is intended. The cobas 4800 hpv test system consists of 2 parts, i. Aliquots from each of the 19 pools at each temperature were tested for hpv dna with the cobas hpv test using the pretreatment process at day 0 and months 1, 3, 6, and 9. Analytical comparison of the cobas hpv test with hybrid. The cobas hpv test with surepath is not approved as a firstline primary hpv screening test. The test runs on the cobas 68008800 systems and has a fullprocess negative control, positive control and internal control. The cobas hpv test know the details of patient risk as early as the first test. Testing and genotyping of highrisk human papillomavirus by. This website contains information on products that are targeted to a wide range of audiences and could contain product details or information otherwise not accessible or valid in your country. Pdf evaluation of the cobas 4800 hpv test for detecting. Between the cobas 4800 hpv test and the seeplex hpv4a ace, there was a concordance rate of 89. Pdf a comparison of the roche cobas hpv test with the hybrid. The cobas human papillomavirus hpv test cobas was recently approved by the u. The hpv test is a qualitative multiplex assay that provides detection of 14 highrisk hpv types, as well as specific genotyping information for hpv types 16 and 18.
Chhieng 2016 a comparison of the roche cobas hpv test with the hybrid capture 2 test for the detection of highrisk human papillomavirus genotypes. For the cobas hpv test, the archived thinprep primary vial samples were prealiquoted for testing and processed for cytology on the t2000 or t3000 processor, as described. Research paper comparison of the cobas 4800 hpv test and. The cobas hpv test is clinically validated and fdaapproved to provide. The hpv16 and hpv18 results were highly consistent between the cobas and linear array tests. O estudo demonstra a capacidade do teste dos cobas hpv.
The intended targets for the cobas 4800 ctng test include all fifteen major chlamydia trachomatis serovars. The detail to make decisions based upon your patients real risk. Per the ce package insert information, indications for use of the the cobas 4800 hpv test are 1. The test is a realtime rtpcr test intended for the qualitative detection of nucleic acids from sarscov2 in nasopharyngeal and oropharyngeal swab samples from patients who meet the cdc sarscov2 clinical criteria. Finally, 5,621 samples were tested using the cobas hpv test to determine the effects of vortexing and swirling before cobas testing on failure rates. One set of cobas 480 hpv test positive and negative controls are included in each run.
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 brushspatula and placed in the thinprep pap test tm preservcyt solution or using a cervical broom and placed in surepath preservative fluid. A comparison of the roche cobas hpv test with the hybrid capture 2 test. The cobas hpv test detects all fourteen hrhpv genotypes 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68. Defined egfr mutations are detected using dna isolated from formalinfixed paraffinembedded tumor tissue ffpet or circulatingfree tumor dna cfdna from plasma derived from. 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 brushspatula and placed in the thinprep pap test preservcyt solution or using a cervical broom and placed in surepath preservative fluid. The cobas hpv test is a fully automated realtime pcr dna assay that qualitatively detects the presence of 14 hr hpv genotypes hpv 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68 in cervical specimens. Revolutionizing healthcare one cell at a time the hpv virus invades the mucosa of the basal membrane of the cervix. The cobas egfr mutation test v2 is a realtime pcr test for the qualitative detection of defined mutations of the epidermal growth factor receptor egfr gene in nonsmall cell lung cancer nsclc patients.
The aptima and cervista tests hologic genprobe, san diego, ca were compared for detection of highrisk human papillomaviruses hpv in cervical cytology specimens. The cobas 4800 human papillomavirus hpv test is a qualitative in vitro test for the detection of human papillomavirus in patient specimens. Women who test negative for high risk hpv types by the cobas hpv test should be followed up in accordance with the physicians assessment of screening and medical history, other risk factors, and professional guidelines. This website contains information on products that are targeted to a wide range of audiences and could contain product details or information otherwise. Both false negative and false positive results may occur. Better risk stratification cobas test cobas hpv test. Bernstein, pei hui, kara duch, kevin schofield, and david c. The procedure includes processing of dna extraction. Clinically validated according to international consensus guidelines. The cobas hpv test is used in cervical cancer screening to determine a womans risk of precancer or cancer.
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