Patient name: MAITRY MILIND MANJREKAR Age / Sex: 20years /

Female
Referred by: SELF Patient ID: PR14314
Sample: Combined NP+OP swab in VTM. Sample ID: S0583202
Accessed: 14 February 2021, 13:23. Tube ID: 378451S
Reported: 14 February 2021, 21:30. ICMR ID: 965804275

REPORT: COVID-19 (SARS-CoV-2) TESTING BY REAL-TIME PCR

Test requested: Molecular testing by qRT-PCR for SARS-CoV-2 (Covid-19) RNA from the provided clinical sample.

Test performed: Viral nucleic acids were extracted from the provided sample. A real-time PCR test (dual labeled probe
chemistry) for SARS-CoV-2 was carried out on the extracted nucleic acids along with positive and negative controls using
GenePath's ICMR/CSIR-CCMB and CDSCO approved real-Time RT-PCR Covid-19 diagnostic kit.

Result:
Targets PCR amplification Ct Value*
"RdRP" locus Not Detected -
"N" locus Not Detected -
"E" locus Not Detected -
*
The PCR amplification cycle threshold (Ct) value is only reported when amplification is seen for that target. Ct values vary inversely with the logarithmic
concentrations of nucleic acid targets in the sample i.e. a low Ct value is indicative of a high target concentration. Please note that this is not a quantitative
assay. Ct values can vary due to a number of factors including, but not limited to, the test kit used, the PCR instrument used, choice of fluorescent dyes, method
of Ct calling, setting of baseline threshold, sample preparation methodology used, and cycling conditions. Ct values from different labs and even from the same
lab are not directly comparable.

Summary: SARS-CoV2 RNA was not detected in the combined nasopharyngeal (NP) and oropharyngeal (OP) swab
sample of MAITRY MILIND MANJREKAR. All controls and quality metrics performed to specification. Please correlate with
clinical and other investigational findings.
Note: GenePath Diagnostics is authorized by the Government of India - ICMR (Indian Council for Medical Research) and the NABL (National
Accreditation Board for Testing and Calibration Laboratories) to carry out Covid-19 testing in India. The lab’s ICMR registration number is GDIPLP
and NABL certificate number is MC-3361. SARS-CoV-2 detection was performed using GenePath Diagnostics’ ICMR/CSIR-CCMB & CDSCO approved
CoViDx One v2.1 test kit. The kit, when used in conjunction with an appropriate sample preparation protocol, is capable of highly sensitive detection of the
SARS-CoV-2 RNA extracted from respiratory tract samples such as nasopharyngeal (NP) or oropharyngeal (OP) swabs, nasal swabs, sputum, etc. This
realtime PCR assay is directed against three targets in the SARS-CoV-2 genome – the “RdRP”, “N” and “E” genes. The assay also detects an independent
human gene which serves as a control for sample preparation and as a monitor for presence of inhibitory substances. The SARS-CoV-2 virus is generally
detectable by
RT-qPCR in respiratory specimens during acute phases of infection. A positive test result in the early stages of the disease course indicates an active
SARSCoV-2 infection and suggests that the patient is presumptively infected with the virus and should be presumed to be contagious. Please reach out to
your healthcare provider if you receive a Covid-19 Positive report. It is important to note that patients can continue to show low positive results for the
presence of SARS-CoV-2 RNA for several weeks after they have ceased to have active infections and/or ceased to be infectious. Therefore, repeat testing by
RT-qPCR is not suggested unless specifically recommended by your healthcare provider. In such cases, concomitant antibody testing may help in determining
the stage of the infection. Please be aware that positive Covid-19 RT-qPCR test results do not rule out co-infections with other bacteria or viruses. In certain
cases, the SARSCoV-2 virus may not be the cause of symptoms being experienced by the patient. For these cases, testing for the presence of other respiratory
pathogens may also be warranted. Though this SARS-CoV-2 test is highly sensitive and specific, a negative test result does not completely rule out a Covid-19
infection. A false negative result may be generated on account of low viral loads, inappropriate sample collection, sub-optimal sample transport or the presence
of PCR inhibitory substances in the clinical specimen. False negative results could also be caused due to the development of mutations in the viral genome at
the PCR assay primer or probe binding sites. Furthermore, due to the nature of the SARS-CoV-2 infection, the virus may not have been present at detectable
levels at the selected site of sampling at the time of sampling. Repeat testing after 2-3 days is suggested in patients that have tested negative but show a strong
suspicion of infection. Even with repeat testing, negative test results should not be the sole criterion for management of patients. In all cases, clinical
observations and other investigations (e.g. CT) along with epidemiological information should be incorporated into the decision-making process. In spite of all
precautions taken, the error (both administrative and technical) associated with these types of molecular diagnostic tests can be as high as 1-2%. In case
additional information or clarifications are required, please contact the laboratory.

Dr. Kavita Khatod Dr. Meenal Agarwal Dr. Ketki Kelkar (Ramanan) Dr. Nikhil Phadke
MBBS, MS (Cell & Molecular Biology) MD (ObGyn), DM (Medical MD (Pathology) PhD (Molecular and
Regn. No. 2000/02/0923 Genetics) Regn. No. 2004/02/0871 Cellular
Regn. No. 2015/12/5395 Biology)

--- End of Report ...