CR/IP No: Reference No: AALDI2020- .

Test Report
MR/IP/Reg. No: N/A Reference No.:AALDI2020-1276
Patient Name: Anish Kumar Sample Collected Date/Time: 01.12.2020; 03:30 PM

Age/Gender: 46 Years / Male Sample Received Date/Time: 01.12.2020; 05:00 PM

TRF ID: 01339 Sample Reported Date/Time: 01.12.2020; 09:30 PM

SRF ID: --- Sample Collected At: All About Lab

Aadhaar/Passport No. 9373 0440 8402

COVID-19 (Real Time PCR, Qualitative)

Referred By Self

Sample type Nasopharyngeal & Oropharyngeal Swab

ICMR approved Kit Trivitron COVIDSURE

Test Results Biol. Ref.

Result for SARS-CoV-2 (COVID-19) Negative Negative

CT value of ORF1ab Gene (if positive) No Ct 35

Interpretation of Results:
* The amplification signal in RdRp & N Gene indicates Positive result for SARS-CoV-2 specific RNA.
* No amplification signal in RdRp & N Gene indicates Negative result for SARS-CoV-2 specific RNA.
* No amplification signal in RNaseP Gene indicates invalid result which is further confirmed by repeat testing or new sample should be obtained.
* RdRp Gene & N Gene-dual targets for the detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The “dual-target” principle offers
extremely sensitive results while taking care of any ambiguity which can be due to possible mutations in any one target region.
* Threshold cutoff cycle (Ct) is 35 for RdRp Gene & N Gene.
* Ct values may vary from one kit to the other.
* Ct values between nasal and oropharyngeal specimens from same individual may differ.
* Sample collection, poorly collected sample, storage and transportation chain anomalies may adversely impact the Ct values.
Clinical Utility of the Assay:

SARS-CoV-2 (COVID-19) is a new strain of Coronavirus that was discovered in 2019. Common signs of infection include fever, cough, sore throat,
running nose and difficulty breathing. In more severe cases, it can cause pneumonia, severe acute respiratory syndrome and multi organ
failure. Real-time RT-PCR technology based on oligonucleotide hydrolysis (Taqman) with TRUPCR® SARS-CoV-2 RT qPCR kit (V-3.2), in vitro
nucleic acid amplification test for the qualitative detection which allows higher specificity and sensitivity.

Remarks:-

o Testing of referred clinical specimens was considered on the basis of request/referral received from/through State Surveillance Officer
(SSO) of concerned State Integrated Disease Surveillance Programme (IDSP)/ any other health care facility affirming requirements of the
case definition/s.
o A single negative test result, particularly if this is from an upper respiratory tract specimen, does not exclude infection.
o Negative result of Internal control (RNaseP Gene) invalidates the results as the TRUPCR® SARS-CoV-2 RT qPCR kit offers much reliable
“endogenous” internal control which helps in qualifying sample for testing and is essential for testing viral RNA in host organism, in this
case, Human housekeeping gene, RNaseP. Poor sample quality, handling, transportation and/or storage can be checked for which, the
qualitative detection of a human housekeeping gene, RNaseP must be performed.
o According to Centre for Disease Control and Prevention, Respiratory Viruses Branch, Division of Viral Diseases, all clinical samples should
be tested for human RNaseP Gene to assess specimen quality for Real-Time RT-PCR for Detection 2019-Novel Coronavirus .

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