Products/Aptima Combo 2 Assay

Aptima Combo 2 Assay

Hologic
510(k) ClearedCE-IVD

Simultaneous detection of Chlamydia trachomatis and Neisseria gonorrhoeae

Technical Specifications

PlatformPanther
MultiplexNo
Target Count2
Sensitivity≥99%
Specificity≥99%
Turnaround Time3 hr
Storage Temperature2–30°C
Shelf Life12 months

Pathogen Targets (2)

Neisseria gonorrhoeae· bacteriaChlamydia trachomatis· bacteria

Sample Types

Oropharyngeal swab

Urine

Vaginal swab

Detection Methods

NAAT

Regulatory Status

FDA510(k) Cleared

K021345

510(k)

7/1/2002

EMA / CE-IVDCE-IVD

Class: Class C

Pricing

USD $18–$35

Per per test

Source: estimate · Confidence: 70%

Pricing is estimated. Contact manufacturer for current pricing.