Xpert® CT/NG
Brand(s)
Summary
Contact the manufacturer if you require additional information.
Affected products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| Xpert® CT/NG | 1001408792 | GXCT/NG-CE-10 |
| Xpert® CT/NG | 1001420349 | GXCT/NG-CE-10 |
| Xpert® CT/NG | 1001414293 | GXCT/NG-CE-10 |
| Xpert® CT/NG | 1001455200 | GXCT/NG-CE-10 |
Issue
Cepheid has become aware of a rare genetic mutation event between Neisseria gonorrhoeae and Neisseria meningitidis that caused some Neisseria gonorrhoeae strains to lack target sites for the Cepheid Xpert® CT/NG test, leading to false negative results.
Cepheid recommends that laboratories and clinics using the Xpert® CT/NG test as their molecular method for the detection of N. gonorrhoeae monitor for decreases in the positivity rate and ensure that discordant laboratory results (e.g. testing negative on the Xpert® CT/NG test but positive for NG by culture/microscopy or testing negative on Xpert® CT/NG test but positive for NG using another NAAT) be investigated further and reported to cepheid.
Additional information
Details
Cepheid AB
Rontgenvagen 5, Solna, Sweden, 17154
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