[5625304]
On (b)(6) 2015 biom? Rieux received a complaint about false negative results obtained while using the vidas varicella-zoster igg. Vidas varicella-zoster igg (vzg) is an automated qualitative test for use on the instruments of the vidas family, for the detection of igg antibodies to varicella zoster virus in human serum using the elfa (enzyme linked fluorescent assay) technique. Vidas vzg is intended as an aid in the determination of immunological experience with varicella zoster virus. The customer performed a study comparing the vidas vzg test to the alegria test (manufactured by launch diagnostics). The study was performed by retesting twenty-three (23) stored blood samples of seventeen (17) pregnant women who had come in contact with the varicella-zoster virus from 2008 through 2014. The vidas vzg test reported twenty-one (21) negative results and two (2) equivocal results. The alegria test reported nine (9) positive results, two (2) negative results and twelve (12) equivocal results. The vidas result was reported to the physician, and the patient received immunoglobulin treatment. No adverse patient consequence was reported as a result of the treatment provided. As part of biomerieux's investigation, three (3) different lots (1003256630 exp. Date: 20-apr-2015, (b)(4) exp. Date: 27-jul-2015 and (b)(4) exp. Date: 24-nov-2015) from various points within their shelf-life were used to perform testing. Ten (10) samples known to give positive or equivocal results for the varicella virus were tested on each of the retained lots. The samples tested positive or equivocal results, as expected. Based on the results of the investigation, vidas varicella-zoster igg remains within the performance claims of the product.
Patient Sequence No: 1, Text Type: D, B5