Patient's name : Mr Rahul Shanbag Age/Sex : 31 Years Male

Referred by : Dr. Bhargav N Patel Md(micro) Reg. No : 2241

Date : 25/12/2020 Mobile : 7045931211
Ref No. : COVID-6471-25
Patient's Id : HM51

SARS-Cov-2 (COVID - 19) QUALITATIVE RT-PCR

METHOD: Real Time RT-PCR (Qualitative) ICMR Reg No.: CUHPLAG

RdRp gene: TARGET NOT DETECTED
TARGET NOT DETECTED
E gene:

N gene: TARGET NOT DETECTED

Conclusion: COVID – 19 NEGATIVE

Panel Comments:
This molecular test uses Real time PCR technology based on nucleic acid amplification assay for qualitative detection of RNA of Novel
Coronavirus (Covid-19) from Respiratory samples (Throat, Nasopharyngeal swab, BAL fluid & sputum samples). It is an in-vitro diagnostic
test that detects very low levels of COVID-19 RNA in Human clinical samples.
1. "Target Detected" results indicates presence of SARS-Cov-2 in the sample. Positive result does not rule out infection with bacterial or other
viral co-infections.
2. "Target Not Detected" result indicates absence of SARS-Cov-2 infection in the given specimen with the assay used.
A negative result does not exclude the possibility of COVID-19 infection as the results are dependent on many other factors.
Limitations:
1. The results of test are highly dependent on the sampling technique employed, sample type, cold chain maintenance and clinical conditions.
2. FALSE NEGATIVE results may be obtained in case of Presence of PCR inhibitors (Can to be traced by technologists) or viral load lesser
than the assay lower limits of detection as well as rare genotypes or mutations.
3. FALSE POSITIVE may be obtained in case of RNA contamination from preanalytical in lab environment.
4. The assay perfomanance characteristics for this test are determined by ICMR approved manufacturer which is used for clinical diagnosis.
Notes:
1. Results must be interpreted in conjunction with other clinical and/or laboratory findings.
2. Negative results doesn’t not rule out the possibility of COVID-19 infection. Presence of inhibitors in sample, mutations at primer or probe
binding sites or insufficient RNA in patient sample can influence the results.
3. Test reports should be correlated with the clinical presentation and findings.
4. A number of factors could lead to a negative result in an infected individual including
* Poor quality of the specimen, containing inadequate patient material or non-representetive specimen.
* The specimen was collected late or very early in the infection. Optimum specimen types and timing for peak viral levels during infections
caused by 2019-nCoV have not been determined. Collection of multiple samples from the same patient may be necessary to detect the
virus.
* The specimen was not handled and shipped appropriately.
* Technical reasons inherent in the test. e.g Virus mutation or PCR inhibition. * Inadequate numbers of organisms are present in the
specimen.
7. Repeat sampling and testing of lower respiratory specimen is strongly recommended in severe or progressive disease.
8. The repeat specimen ns may be considered after a gap of 2-4 days after the collection of the first specimen for additional testing if required.
9. Categories of viral load is based on cycle threshold (Ct) detected by RT PCR. a.) High viral load : 17 to 24
b.) Moderate viral load : 24 to 31
c.) Low/Mild viral load : 31 to 38

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