- The CAMPYLOBACTER CHEK™ test offers accurate diagnostic results in ~ 1 hour; culture can take up to 72 hours and is prone to false negative results due to stringent transport and growth conditions.
- Flexible specimen types include fresh, frozen, and Cary Blair and C&S transport media.
- The CAMPYLOBACTER CHEK™ test detects C. jejuni and C. coli.
- Shown to cross-react with C. upsaliensis, C. lari, and C. helveticus in clinical and analytical studies.
The CAMPYLOBACTER CHEK™ test is an enzyme immunoassay for the qualitative detection of a Campylobacter-specific antigen in human fecal specimens. The CAMPYLOBACTER CHEK™ test is designed to detect C. jejuni and C. coli from patients with signs and symptoms of gastroenteritis. The test also reacts with pathogenic C. upsaliensis and C. lari. The test is intended for use with preserved fecal specimens in transport media and unpreserved fecal specimens.
CAMPYLOBACTER CHEK™ test versus Culture
|N = 1552||Culture Positive||Culture Negative|
|95% Confidence Limits|
|Sensitivity||91.4%||77.6% - 97.0%|
|Specificity||99.1%||98.5% - 99.5%|
The 17 discrepant specimens were further characterized by additional testing at TECHLAB. This testing included an FDA-cleared commercial Microassay well EIA, an FDA-cleared commercial molecular test, in-house PCR (detecting the 16s rRNA gene of Campylobacter spp., and species-specific identification), and bidirectional sequencing.
* Eight of the 14 specimens that were culture negative and CAMPYLOBACTER CHEK™ test positive were confirmed to be positive with all tests.
Two of the 14 specimens that were culture negative and CAMPYLOBACTER CHEK™ test positive were confirmed to be positive with the commercial EIA, in-house PCR, and bidirectional sequencing.
Four specimens that were culture negative and CAMPYLOBACTER CHEK™ test positive were confirmed to be positive for C. upsaliensis (an important pathogen) by species-specific PCR and sequencing.
** One of the three specimens that were culture positive and CAMPYLOBACTER CHEK™ test negative was confirmed to be negative with all tests.
|T31096 (US & Global)