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Although there are no published evaluations of this product in the last 10 - 15 years, the Wellcolex Shigella color latex test had high sensitivity and specificity in published evaluations in the early 1990s (J Clin Microbiol 1992;30(8):2184, Diag Microbiol Infect Dis 1992;15(1):1). This kind of performance indicates that you could report Shigella as a final report with this product. Make sure you cite these articles in your procedure manual and provide the performance characteristics too. You should also do a small evaluation in your own lab to corroborate the published data and make yourself and the inspectors comfortable that the test works well in your lab.
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