Based on the feedback from development, the mentioned sequence is not expected to be detected with the cobas® egfr mutation test v2.Roche received complaints from customers reporting the generation of false mutation detected results for the exon 20 insertion (ex20ins) mutation when using the cobas® egfr mutation test v2.During in-house testing using customer-provided ffpet samples, an ex20ins false mutation detected result was reproduced for one out of 8 ffpet samples, which was processed following the validated sample preparation method from the instructions for use.Although the majority of cases reported were from users using ffpet samples, the generation of false mutation detected ex20ins results with plasma specimens was reported in one case.A false mutation detected ex20ins result could lead to harm under specific scenarios.Consignees have been notified of the issue with instruction to follow the instructions for use for sample input requirements.Additionally, if an ex20ins mutation detected result is generated with the cobas® egfr mutation test v2, customers must confirm the result with another method (e.G., sequencing or other pcr-based tests).
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An investigation concluded that the cobas® egfr mutation test v2 is not expected to detect the sequence that was expected for this external control (h773-v774insgnph exon 20).Therefore the ex20ins mutation detected result is considered a potential false positive result.As per the customer, the alleged sample was expected to be h773-v774insgnph exon 20.When the sample was tested on the cobas® egfr mutation test v2, the result was exon20 mutation detected.Note, the alleged sample is an external control from the spanish society of pathological anatomy (seap) organization.Its composition is unknown (contrived or from a single patient donor).The results were sent back to seap.No harm or injury alleged.
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