A study to evaluate the correlation of the cobas 4800 CT/NG test with the Abbott m2000 CT/NG test

A study to evaluate the correlation of the cobas 4800 CT/NG test with the Abbott m2000 CT/NG test - cobas CT/NG test

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON33357

Enrollment

1200

Registered

2009-07-08

Start date

2009-11-01

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chlamydia STD

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Suspected for STD

Exclusion criteria

Exclusion criteria: None

Design outcomes

Primary

Measure	Time frame
The statistical analyses will be performed separately for each type of specimen. The positive correlation, negative correlation and overall agreement (total concordance) of the cobas 4800 CT/NG Test to the Abbott m2000 CT/NG Test will be calculated along with the 95% confidence intervals. Calculations will be done with initial results as well as final resolved results. The cobas 4800 CT/NG Test and the Abbott m2000 CT/NG Test shall be considered equivalent by having the exact 95% (one-sided) confidence bound for percent Chlamydia trachomatis positive specimen greater than 90%. The cobas 4800 CT/NG Test and the Abbott m2000 CT/NG Test shall be considered equivalent by having the exact 95% (one-sided) confidence bound for percent Neisseria gonorrhoeae positive specimen greater than 90%. In the event that the final samples sizes for the endocervical swab CT and/or NG positive specimens falls below 50, an overall cobas 4800 CT/NG Test positive correlation of at least 95% must be met for both CT and NG to show equivalence to the Abbott m2000 CT/NG Test.	—

Measure

Time frame

The statistical analyses will be performed separately for each type of specimen. The positive correlation, negative correlation and overall agreement (total concordance) of the cobas 4800 CT/NG Test to the Abbott m2000 CT/NG Test will be calculated along with the 95% confidence intervals. Calculations will be done with initial results as well as final resolved results. The cobas 4800 CT/NG Test and the Abbott m2000 CT/NG Test shall be considered equivalent by having the exact 95% (one-sided) confidence bound for percent Chlamydia trachomatis positive specimen greater than 90%. The cobas 4800 CT/NG Test and the Abbott m2000 CT/NG Test shall be considered equivalent by having the exact 95% (one-sided) confidence bound for percent Neisseria gonorrhoeae positive specimen greater than 90%. In the event that the final samples sizes for the endocervical swab CT and/or NG positive specimens falls below 50, an overall cobas 4800 CT/NG Test positive correlation of at least 95% must be met for both CT and NG to show equivalence to the Abbott m2000 CT/NG Test.

—

Secondary

Measure	Time frame
n.a.	—

Countries

Netherlands

Outcome results