High-throughput testing of urogenital and extragenital specimens for detection of Chlamydia trachomatis and Neisseria gonorrhoeae with cobas® CT/NG

Abstract

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 Chlamydia trachomatis (CT) and ≤1 CFU/ml for Neisseria gonorrhoeae (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.

Evaluation of a quantitative RT-PCR assay for the detection of the emerging coronavirus SARS-CoV-2 using a high throughput system

“…Automated solutions for molecular diagnostics can help handle large numbers of samples and can be scaled to keep pace with fluctuating demand [10][11][12].…”

Men and Women Have Similar Neisseria gonorrhoeae Bacterial Loads: a Comparison of Three Anatomical Sites

“…Therefore, bacterial load can be quantified by interpolation of Cq values to a standard curve with known concentrations of N. gonorrhoeae. For quantification, a standard curve was made for each specimen type (e.g., swab or urine) as the Cobas 4800 CT/NG test requires different volumes of input material (20). N. gonorrhoeae suspension from log-phase culture was spiked (100 l) and serially diluted 10-fold.…”

The epidemiology, diagnosis and treatment of COVID-19

“…The RT-PCR results usually become positive after several days (2-8 days) [27] . Automated solutions for molecular diagnostics can handle large numbers of samples and can be scaled to keep pace with fluctuating demand [28][29][30] . The good analytical performance of a molecular assay for the detection of SARS-CoV-2 on a highthroughput platform, the cobas 6800, was observed with minimal hands-on time, while offering fast and reliable results [31 , 32] .…”