Roche Diagnostics Cobas™ Liat CT/NG RT-PCR Assay Kit

Catalog No.	Clia Complexity
21-200-312	Waived

Catalog No. 21-200-312 Supplier Roche Diagnostics Supplier No. 10030933190

Description

The Cobas™ liat CT/NG/MG test is an automated, qualitative in vitro nucleic acid diagnostic using real-time PCR for the detection of CT and NG in male urine and vaginal swabs.

The cobas™ liat CT/NG nucleic acid test is an automated, qualitative in vitro nucleic acid diagnostic test that utilizes real- time polymerase chain reaction (PCR) for the direct detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) nucleic acid in male urine and vaginal swabs, all in cobas™ PCR Media (Roche Molecular Systems, Inc.). This test is intended as an aid in the diagnosis of urogenital infections in both symptomatic and asymptomatic individuals.

Specifications

• Content And Storage: 20 tests per kit; store at 2°to 8°C
• Clia Complexity: Waived
• Detectable Analytes: Chlamydia trachomatis, N. gonorrhoeae
• Sensitivity: Chlamydia: male urine (97.3%); vaginal swab (98.2%). Gonorrhea: male urine (100.0%); vaginal swab (97.7%).
• Type: PCR test
• For Use With (Application): The cobas™ liat CT/NG test is an automated, qualitative in vitro nucleic acid diagnostic using real-time PCR for the detection of CT and NG in male urine and vaginal swabs.
• Includes: 20 tests per kit; pipettes
• Quantity: 20 tests per kit
• Specificity: Chlamydia: male urine (99.9%); vaginal swab (99.8%). Gonorrhea: male urine (99.9%); vaginal swab (99.8%).
• Analysis Time: 20-minutes
• Dimensions (L x W x H): 10.7 x 6.5 x 5.7 in.
• Weight (English): 2.3 lb.
• Form: Ready-to-Use (RTU)
• Operating Temperature Range: 2° to 8°C