[59874142]
Results from different zika assays are discrepant. Focus diagnostics performed an investigation of the discrepant result which showed that there were not procedural nor material problems with the assay. Reagents were within expiration dating and showed no clear trends. Extraction and pcr runs/ batches showed that all pcr ct values and amplification curves for the assay controls were valid. Pcr ct values and amplification curves for the pt specimens were properly interpreted as specified in the tsop focus discussed pts' clinical history and epidemiological risk factors, and f/u testing with the public health authorities, and based on the data provided, classified the discrepant as a suspected false positive result. Our investigation and analysis suggests the root causes for the discrepant result was due to a difference in assay performance when compared with the results generated by the cdc trioplex assay and the associated potential issues with reproducibility at low viral loads. Because of the low rate of false positive results focus did not believe that is was appropriate to change the design of the assay. Focus has made labeling changes to further communicate the risks of the assay. Specimen that was collected 4 days post-symptoms onset was positive in the focus zika virus rna qualitative real-time rt-pcr test and negative with the igm assay (cdc mac igm elisa) performed by the public health lab. Specimen(s) collected 14 days post-symptom onset were negative in the public health laboratory molecular assays (cdc trioplex pcr assay and a cdc ldt pcr assay) and the igh assay (cdc mac igm elisa). Pt's history and clinical symptoms did not meet the cdc criteria for zika infection. No history of travel to a known region with zika transmission, no known sexual contact with person with possible zika exposure, pt had nonspecific symptoms, symptom onset date was (b)(6) 2016.
Patient Sequence No: 1, Text Type: D, B5