A customer in (b)(6) had reported to biomérieux that they have observed false negative results when using the products vidas® lyme igm (ref.30319) lot 1005810050 and vidas® lyme igg (ref.30320) lot 1005816250, whereas positive results were obtained using euroline western blot.An internal biomérieux investigation was performed.The analysis of the batch history records for vidas lyme igm 1005810050/180614-0 and vidas lyme igg 1005816250/180622-0 showed no anomaly during the manufacturing and control processes.The analysis of control charts of 12 internal samples (1 negative, 4 equivocal, 7 positive) on 15 vidas lyme igm batches and 10 internal samples (3 negative, 7 positive) on 7 vidas lyme igg batches (including lots mentioned by customer) showed that all the results are within specifications.Vidas lyme igm 1005810050/180614-0 and vidas lyme igg 1005816250/180622-0 are within the trend of the other batches.The complaint laboratory tested five internal samples (1 equivocal, 4 positive) on the retain kit vidas lyme igm lot 1005810050/180614-0 and five other internal samples (1 negative, 4 positive) on the retain vidas lyme igg lot 1005816250/180622-0.The results obtained were within the expected specifications and similar to those obtained during release.There is no drift of vidas lyme igm lot 1005810050/180614-0 and vidas lyme igg lot 1005816250/180622-0 since their release.The negative result obtained by the customer was reproduced both on igg and igm and confirmed with another technique (immunoblotting : no visible band or band inferior to the cut off).This result confirmed the vidas interpretation, and there is no reconsideration of the vidas igm and vidas lyme igg performances.Final conclusion : according to all the data mentioned above, vidas lyme igm 1005810050/180614-0 and vidas lyme igg 1005816250/180622-0 are within the expected specifications.No other complaint was recorded for a sensitivity issue on vidas lyme igm 1005810050/180614-0 and vidas lyme igg 1005816250/180622-0.
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