We compared the analytical and clinical performance of cobas CT/NG for use on the Cobas 6800/8800 Systems with the Cobas 4800 CT/NG Test from urogenital and extragenital specimens in over 12,000 specimens from both male and female subjects in Germany and the United States. The analytical sensitivity was ≤40 EB/ml for (CT) and ≤1 CFU/ml for (NG). Using clinical specimens, the overall percent agreement with the Cobas 4800 CT/NG Test was >98.5%. Across urogenital specimens, there were 93 discrepant specimens; 76 (93.8%) of 81 CT discrepant specimens were 6800+/4800- and 10 (83.3%) of 12 NG discrepant specimens were 6800+/4800-. Sequencing verified CT results for 45 (61.6%) of 73 samples positive by 6800 and 1 (20%) of 5 positive by 4800. Similarly, 7 (70.0%) of 10 NG samples positive by 6800 and 1 of 2 positive by 4800 were confirmed by sequencing. Among discrepant extragenital specimens (all 6800+/4800-), 7 (50%) of 14 oropharyngeal and 23 (76.7%) of 30 anorectal CT discordant samples were confirmed as CT positive by sequencing; all 8 anorectal and 20 (90.9%) of 22 oropharyngeal NG discordant results were also confirmed as NG positive. In conclusion, Cobas CT/NG for use on the Cobas 6800/8800 Systems provides high-throughput automated solutions for sexually transmitted infection (STI) screening programs.
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| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5632745 | PMC |
| http://dx.doi.org/10.1556/1886.2017.00018 | DOI Listing |
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