ID Name Gender Ref. Doctor : SELF Passport No. : - Client Name : SM PATHOLOGY - TTFR035 Client Address : Mumbai 11210621094 MOLECULAR PATHOLOGY Qualitative RNA detection of SARS - CoV - 2 ( COVID 19)* Test Method : Real Time RT – PCR Sample Type : Nasopharyngeal and Oropharyngeal Swab Result SARS - CoV2 (COVID - 19) Negative ICMR Approved Covid 19 Testing Registration No. – IGDM001 Interpretation Negative RNA specific to SARS - CoV - 2 NOT detected Positive RNA specific to SARS - CoV - 2 Detected Indeterminate This could be due to low viral load in the sample. A repeat sample is recommended for confir mation Important Note: 1. SARS - CoV2 (COVID - 19) Test conducted as per CDC guidelines, protocol of Govt. of India and using ICMR validated/CE - IVD test kits1,2 2. Clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co - infection with other pathogens. Test does not distinguish between a viable/ replicating organism and a non - viable organism. 3. As with all viral PCR assays, patients with v ery low viral loads are less likely to be detected. Negative result does not rule out the possibility of Covid - 19 infection. Presence of inhibitors, mutations & insufficient organism RNA can influence the result. Negative results must be combined with clinical observations, patient history, and epidemiological information. 4. There are no reliable studies to definitively prove a direct correlation between disease severity / infectiousness and Ct val ues. Viral load does not have much role in patient managem ent. Samples from asymptomatic/mild cases may show Ct values similar to those who develop severe disease. <3/sup> 5. This PCR assay is able to detect all known SARS CoV - 2 variants to date. In view of the above, it is not recommended to rely only on numerical Ct values for determining infectiousness of COVID - 19 patients and deciding patient management protocols. Comments The iGenetic Diagnostics SARS - CoV - 2 RNA Qualitative Real - Time RT - PCR is a real - time RT - PCR test intended for the qualitative detection of nucleic acid from the SARS - CoV - 2 in upper and lower respiratory specimens (such as nasopharyngeal or oropharyngeal swabs, sputum, tracheal aspirates, and Broncho - alveolar lavage) collected from individuals suspected of COVID - 19. References: Coronavirus Disease 2019 (COVID - 19) https://www.cdc.gov/coronav irus/2019 - ncov/symptoms testing/testing.html Strategy of COVID19 testing in India: https://www.icmr.nic.in/content/covid - 19 https://www.icmr.gov.in/pdf/covid/techdoc/Advisory_on_correlation_of_COVID_severity_with_Ct_values.pdf Page 1 of 1 1610286 : SURYAANSH RANINGA DOB/Age : 17 years : Male Nationality : Indian Collection : 06/12/2021, 02:04 PM Received : 06/12/2021, 05:32 PM Reported : 07/12/2021, 04:29 PM