Unspecified date: patient presented to emergency room with symptoms consistent with strep.A throat culture was collected using a dual swab technique and tested on the proadvantage strep a kit which provided a (b)(6) result.No treatment was provided based on the (b)(6) result.The alternate swab was sent for confirmatory testing on the same day, however, the results were not obtained until a few days later.The result of the confirmatory culture was (b)(6).Although further information was requested, no further information was provided.
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An investigation was performed on retention product from the reported lot number.Retention devices were tested with qc cutoff standards (2.5e07 org/ml).Results were read at 5 minutes and all devices yielded expected positive results.No false negative results were observed during in-house testing.Manufacturing batch record review did not uncover any abnormalities and found that the lot met quality control specifications.A root cause could not be determined from the available information as retention product performed as expected during in-house testing.Case details indicate that it is unknown whether the confirmatory culture was specific to strep a.Please note, this device is a qualitative, lateral flow immunoassay for the detection of strep a carbohydrate antigen.Furthermore, a negative result may be obtained if the concentration of the strep a antigen present in the throat swab is not adequate or is below the detectable level of the test.Alere san diego will continue to monitor this issue through incoming complaints.
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