ID : 22826 Collection : 28/12/2021, 10:11 PM Client Name : DR Ronak Mukesh

Name : ANDERSON ESTIBEIRO Received : 29/12/2021, 07:20 AM Khokhani - TTFRLB004

DOB/Age : 31 years Reported : 29/12/2021, 10:35 AM Client Address :
Gender : Male Ref. Doctor : SELF
Nationality : Indian Passport No. : - 4221122572

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

This could be due to low viral load in the sample. A repeat sample is
Indeterminate
recommended for confirmation

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 very 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 values. Viral load does not have much role in patient management. 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/coronavirus/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

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