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Meril COVID-19 One-Step RT-PCR Kit

A COVID-19 test was performed on a sample from Mrs. Vipna Devi, a 40-year-old female. The test was a real-time reverse transcription polymerase chain reaction (RT-PCR) test using an ICMR-approved kit. The test results were negative, meaning SARS-CoV-2 RNA was not detected in the sample. The report provides information on the test methodology, significance, limitations, and references.

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Ankit Rana
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266 views2 pages

Meril COVID-19 One-Step RT-PCR Kit

A COVID-19 test was performed on a sample from Mrs. Vipna Devi, a 40-year-old female. The test was a real-time reverse transcription polymerase chain reaction (RT-PCR) test using an ICMR-approved kit. The test results were negative, meaning SARS-CoV-2 RNA was not detected in the sample. The report provides information on the test methodology, significance, limitations, and references.

Uploaded by

Ankit Rana
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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AC105661

Patient NAME : Mrs.VIPNA DEVI Sample Collection Time : 02/Nov/2020 07:10PM


Age/Gender : 40 Y 11 M 7 D /F Sample Received in Lab Time : 02/Nov/2020 07:11PM
UAID/Oth.Lab Ref. : AC10.0000004740/ Reported Time : 03/Nov/2020 09:16AM
SIN No. : ABA55674 Ref. Doctor : Dr.SELF

DEPARTMENT OF MOLECULAR BIOLOGY IN/OUT SAMPLE :InHouse Sample


COVID-19 (Real Time PCR)

ICMR Registration No.: ATHCC


Sample type: Nasopharyngeal & Oropharyngeal Swab
ICMR approved Kit : Meril COVID-19 One-step RT-PCR kit

COVID – 19 (Real Time PCR Qualitative)


Test Results Biological Reference Interval
Result for SARS Coronavirus-2/COVID 19
Negative Negative
(RT PCR)
CT value of N gene if positive -
CT value of ORF 1ab gene if positive -

Interpretation

Result Remarks
Positive RNA specific to SARS-CoV-2 Detected
Negative RNA specific to SARS-CoV-2 Not Detected

Note:
1. The Ct value is inversely proportional to the amount of genetic material (RNA) in the starting sample and Lower Ct value generally correlate
with high viral load.
2. Ct values differ from one kit to the other.
3. Ct values also depend on how the sample has been collected. A poorly collected sample may reflect inappropriate Ct values.
4. Ct values between nasal and oropharyngeal specimens collected from the same individual may differ.
5. Temperature of transportation as well as time taken from collection to receipt in the lab can also adversely impact Ct values.
6. According to ICMR guidelines CT values should not be used to monitor the severity of disease.
Methodology
Real Time Reverse Transcription Polymerase Chain Reaction (RT PCR) test for the detection of RNA form SARS CoV2 in human nasopharyngeal
and oropharyngeal swab specimens.
Clinical significance
SARS CoV 2 is the causative agent for corona virus disease 2019 or COVID-19 in Humans. SARS CoV 2 is a Beta Corona Virus, one of the four
genera of Corona Viruses. Coronaviruses are enveloped non-segmented positive sense RNA viruses belonging to the family coronaviridae and

Page 1 of 2

ATULAYA HEALTHCARE COVID COLLECTI ATULAYA HEALTHCARE CHANDIGARH


Leisure Valley, Sector 10 H No.11,Sector 11A,
Chandigarh Chandigarh
AC105661

Patient NAME : Mrs.VIPNA DEVI Sample Collection Time : 02/Nov/2020 07:10PM


Age/Gender : 40 Y 11 M 7 D /F Sample Received in Lab Time : 02/Nov/2020 07:11PM
UAID/Oth.Lab Ref. : AC10.0000004740/ Reported Time : 03/Nov/2020 09:16AM
SIN No. : ABA55674 Ref. Doctor : Dr.SELF

DEPARTMENT OF MOLECULAR BIOLOGY IN/OUT SAMPLE :InHouse Sample


the order Nidovirales and broadly distributed in humans and other mammals. The common signs of COVID-19 infection include respiratory
symptoms, fever, cough, shortness of breath and breathing difficulties. In more severe cases, infection can cause pneumonia, severe acute
respiratory syndrome, kidney failure and even death. Early and correct identification of infection with SARS CoV-2 is important for effective
isolation, treatment and case management of COVID-19.
Principle
In the presence of the target, primers and probes will hybridize to the specific sequence and allow amplification by the polymerase. The level
of fluorescence increases with the generation of amplicons and is proportional to the amount of pathogen nucleic acid contained in the
sample. The increased fluorescence level is reported as a cycle threshold (Ct) value by the real-time thermocycler.
Target Selection
The target sequence is N and ORF 1ab gene of SARS CoV2.
Limitations
* Negative result does not rule out COVID-19 infection. It should be interpretated along with the history, clinical findings and other
epidemiological factors.
* Positive results indicate infection but the possibility of infection with other similar viruses cannot be ruled out.
* This kit is a qualitative kit that does not provide a quantitative value for the detected pathogens in the specimen.
* This test shall not be the only element consulted for diagnosis or treatment decision. A specimen not detected cannot be presumed to be
negative for this pathogen since results are dependent on several variables as explained above.
* Reliable results of this test require appropriate specimen collection as well as appropriate specimen and kit transport and storage and
processing procedures. Failure to follow these procedures will produce incorrect results, leading to false positive and negative values or invalid
results.
* Possibility of false negative results due to mutations and rapid evolution of the virus cannot be ruled out.
* Optimum timing for peak viral load during infections caused by novel Coronavirus have not yet been fully determined. So multiple samples
might be needed from same patient at different times.
* False negative results may occur due to the presence of amplification inhibitors in the sample or insufficient organisms in the sample.
* Samples with low and very low viral load may give variable results on repeat testing.
Note: Test is performed using ICMR approved kit.
References:
* The Institut Pasteur website:
https://www.pasteur.fr/en/medical-center/disease-sheets/covid-19-disease-novel- coronavirus#symptoms. Accessed March 2020.
* Center for Disease Control (CDC) website: https://www.cdc.gov/urdo/downloads/SpecCollectionGuidelines.pdf. Accessed March 2020.
* CDC Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens from Patients Under Investigation (PUIs) for 2019 Novel
Coronavirus. https://www.cdc.gov/coronavirus/2019-nCoV/guidelines-clinical-specimens.html. Accessed May 2020.
* World Health Organization (WHO). Laboratory testing for coronavirus disease 2019 (COVID-19) in suspected human cases: Interim guidance,
2 March 2020.
*ICMR:https://www.icmr.gov.in/pdf/covid/techdoc/Advisory_on_correlation_of_COVID_severity_with_Ct_values.pdf
*** End Of Report ***

Page 2 of 2

ATULAYA HEALTHCARE COVID COLLECTI ATULAYA HEALTHCARE CHANDIGARH


Leisure Valley, Sector 10 H No.11,Sector 11A,
Chandigarh Chandigarh

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