Scan to Validate Patient name: SAMUEL KONNUR Referred by: Self Sample: Combined NP+OP swab in VTM Accessed: August 09, 2021 11:46 Reported: August 09, 2021 19:42 Age / Sex: 32 years / Male Patient ID: PD31546 Sample ID: C101129 Tube ID: 33162D ICMR ID: 445007461 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 SAMUEL KONNUR. All controls and quality metrics performed to specification. Please correlate with clinical and other investigational findings. Individuals who have tested negative, but experience symptoms or have had a recent exposure, are strongly recommended to undergo repeat testing within 2-3 days. Note: Gene Path 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 real- time 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 SARS- CoV-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 SARS- CoV-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 MBBS, MS (Cell & Molecular Biology) Regn. No. 2000/02/0923 Dr. Meenal Agarwal MD (ObGyn), DM (Medical Genetics) Regn. No. 2015/12/5395 Dr. Ketki Kelkar (Ramanan) MD (Pathology) Regn. No. 2004/02/0871 --- End of Report ---