Report
Report
Report
CID : 2128729978
Name : MR.TAHSHEEN SARWAR.T2068900
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Age / Gender : 39 Years / Male Application To Scan the Code
Intended use: It is intended for qualitative detection of SARS CoV-2 RNA from nasal swab specimen from individuals suspected of COVID-19.
Clinical Significance: This test is an IVD approved in-vitro diagnostic test authorized for emergency use by FDA as POCT. Individuals suspected
of COVID-19 by their healthcare provider or those who meet CDC SARS-CoV-2 clinical criteria in conjunction with epidemiological criteria can be
tested using Rapid SARS CoV-2 RT-PCR followed by Lateral Flow oligo hybridization method.
Interpretation:
Limitation:
The test result variation is expected across different testing platforms due to factors such as assay sensitivity, the assay targets &
technology.
Optimum specimen types and timing of peak viral levels during infections caused by SARS-CoV-2 have not been determined. Collection
of multiple specimens (Types & Time points) may be necessary in view of suspected clinical history.
Positive results do not rule out other bacterial infection or co-infection with other viruses.
The test is intended only for use with nasal or nasal mid-turbinate swab specimens.
Improper collection, storage or transport of specimens may lead to false negative or invalid results.
Collection of patient samples into media other than the supplied Accula SARS-CoV-2 Buffer (such as UTM, VTM, or saline), has been
shown to adversely impact test performance.
Reference: Accula SARS CoV 2 test IFU; Accula Dock Operator Guide
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