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CID : 2128729978
Name : MR.TAHSHEEN SARWAR.T2068900
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Age / Gender : 39 Years / Male Application To Scan the Code

Consulting Dr. :- Collected : 14-Oct-2021 / 17:32

Reg. Location : Mumbai Airport - International Departure Reported : 14-Oct-2021 / 18:06

DETECTION OF SARS COVID-19 RNA VIRUS BY RAPID RT-PCR

PARAMETER RESULT
SARS-CoV-2 Not Detected (Negative)

ICMR Registration No: Andheri-Mumbai- SUBUR001

Specimen: Nasal swab in Accula buffer

Method: Rapid RT-PCR followed by lateral flow oligo-hybridization technology.

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.

Clinical sensitivity: 98%; Analytical sensitivity:150 copies/ml; Specificity: 99%

Interpretation:

‡ Detected: SARS CoV-2 virus RNA detected.

‡ Not Detected: SARS CoV-2 virus RNA not detected.
‡ Positive results are indicative of the presence of SARS-CoV-2 RNA.
‡ However, the assay cannot differentiate between live or dead virus hence, infectious status of positive patient cannot be determined.
‡ Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions.
‡ Positive & negative results must be correlated with clinical observations, patient history, and epidemiological information.
‡ The assay includes the internal positive & negative control for valid result interpretation of the specimen tested.
‡ All the positive cases will be notified to ICMR for further surveillance.

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

* Sample processed at Molecular Diagnostics Laboratory, CPL, Andheri West

*** End Of Report ***

Dr.HEENA SATAM Dr.ANUSHREE GAIGAWALE

M.Sc. Microbiology, PhD. Biochemistry M.D. (MICRO); DNB
Molecular Biologist Microbiologist

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