Notice to Readers: Recall of LCx® Neisseria gonorrhoeae Assay and Implications for Laboratory Testing for N. gonorrhoeae and Chlamydia trachomatis
On July 18, 2002, Abbott Laboratories (Abbott Park, IL) initiated a voluntary recall of its LCx® Neisseria gonorrhoeae Assay (List Numbers 8A48-81 and 8A48-82) because, during routine quality assurance testing, several reagent lots failed to meet the analytical sensitivity described in the product insert. The cause of the failure is under investigation by the company. Abbott Laboratories has sent a letter to its customers informing them of this recall and the specific reagent lot numbers not meeting the analytical sensitivity.
The possibility of false-negative results for specimens tested with affected lots has prompted the following actions:
- 1. As recommended by Abbott Laboratories, laboratories should discontinue use of and discard any remaining LCx® N. gonorrhoeae assay reagents.
- 2. Laboratories that have tested specimens using the affected lots should notify their consumers (e.g., health care agencies and clinicians) about the increased risk for a false-negative result on such specimens. Notifications should be documented as required by the Clinical Laboratory Improvement Amendments (CLIA) of 1988.
- 3. For patients whose specimens were tested with the affected lots, clinicians should offer retesting to patients whose test results were negative and who were not presumptively treated.
Separate LCx® assays for the detection of Chlamydia trachomatis and N. gonorrhoeae have been cleared by the Food and Drug Administration (FDA). Although the LCx® C. trachomatis Assay has not been recalled, public health departments have reported delays in obtaining both assays.
For laboratories unable to test specimens for C. trachomatis and N. gonorrhoeae because of the unavailability of LCx® assay reagents, several testing options are available:
- 1. Testing with the LCx® assays can be delayed. Urine specimens or endocervical or urethral swab specimens collected for LCx® testing can be stored at -4o F (-20o C) for up to 60 days before testing with the assay.
- 2. For more timely patient management, the use of other FDA-cleared tests should be considered. Urine specimens that have not been processed for LCx® testing can be tested by using another FDA-cleared nucleic acid amplification test. Only nucleic acid amplification tests are recommended for the direct detection of C. trachomatis or N. gonorrhoeae in urine. Swab specimens collected from patients and placed in LCx® transport medium cannot be tested by using another FDA-cleared test. Health-care providers should consider recalling such patients to collect a new specimen for testing with another FDA-cleared test. If this is done, the laboratory should be consulted about procedures for proper swab collection. Laboratories also could consider culture as an option to test for N. gonorrhoeae.
- 3. In addition, laboratories may consider redirecting their consumers to other laboratories that can provide such screening services.
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