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    Sars-Cov-2 (Covid 19) Detection (Qualitative) by Real Time RT PCR

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    AKSHAY GHADGE
    1) The test results show that SARS-CoV-2 RNA was detected in the patient's sample with a CT value of 20 for the confirmatory gene. 2) A detected result indicates the presence of SARS-CoV-2 in the sample, though viral load may decrease over time as symptoms resolve. 3) A not detected result does not rule out infection and should not be used solely for patient management decisions. Sensitivity depends on sample quality and testing timing.

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    Sars-Cov-2 (Covid 19) Detection (Qualitative) by Real Time RT PCR

    Uploaded by

    AKSHAY GHADGE
    22 views3 pages
    1) The test results show that SARS-CoV-2 RNA was detected in the patient's sample with a CT value of 20 for the confirmatory gene. 2) A detected result indicates the presence of SARS-CoV-2 in the sample, though viral load may decrease over time as symptoms resolve. 3) A not detected result does not rule out infection and should not be used solely for patient management decisions. Sensitivity depends on sample quality and testing timing.

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    01_Report-116211549004609_VILASDHAVALE_A1024_30Apr2021_110104

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    1) The test results show that SARS-CoV-2 RNA was detected in the patient's sample with a CT value of 20 for the confirmatory gene. 2) A detected result indicates the presence of SARS-CoV-2 in the sample, though viral load may decrease over time as symptoms resolve. 3) A not detected result does not rule out infection and should not be used solely for patient management decisions. Sensitivity depends on sample quality and testing timing.

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    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    22 views3 pages

    Sars-Cov-2 (Covid 19) Detection (Qualitative) by Real Time RT PCR

    Uploaded by

    AKSHAY GHADGE
    1) The test results show that SARS-CoV-2 RNA was detected in the patient's sample with a CT value of 20 for the confirmatory gene. 2) A detected result indicates the presence of SARS-CoV-2 in the sample, though viral load may decrease over time as symptoms resolve. 3) A not detected result does not rule out infection and should not be used solely for patient management decisions. Sensitivity depends on sample quality and testing timing.

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    © All Rights Reserved
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    of 3

    Mr. VILAS DHAVALE Reference: Dr.

    SELF VID: 116211549004609


    SR NO 19/6/2 LEN NO 17/8 RAIKAR NAGAR Client Address: Registered On:
    DHAYARI, HAVELI Mrs manjiri mahesh shirolkar 30/04/2021 11:01 AM
    Tel No : 9763731388 Office at 11, laxmi narayan maruti,-opp. Collected On:
    PIN No: 411041 p.l. deshpande garden,-sinhgadh road,
    30/04/2021 11:01AM
    pune 411030
    PID NO: P1162100291582 Reported On:
    PROCESSING LOCATION:- Metropolis
    Age: 52.0 Year(s) Sex: Male Healthcare Ltd. Bhandarkar Road, 01/05/2021 08:16 AM
    Pune - 411004

    SARS-CoV-2 (COVID 19) Detection (Qualitative) by Real Time rt PCR

    Test : Qualitative RNA detection of SARS-CoV-2 (COVID19)

    Specimen Type : Swab : Nasopharyngeal and Oropharyngeal

    Test principle : Real time reverse transcription PCR (ICMR approved kit)

    Test description : Screening by “E” gene detection and Confirmation by


    “RdRp , N or S” gene detection

    Result :

    SARS-COV-2 RNA DETECTED 20

    Comments : CT VALUE FOR CONFIRMATORY GENE IS: 20

    ICMR guidelines do not recommend sole dependence on Ct Value for patient management.

    The kit used for this SARS CoV 2 RT PCR test at Metropolis Healthcare ltd covers multiple targets and
    detects most of the possible mutations in current circulation such as UK strain, South african strain,
    Brazilian strain etc. however it may not be able to differentiate between them.

    We are sending such samples suspected of mutant strains which are recognised as significant to
    National influenza centre, Pune for further genome sequencing as per the guidelines issued by ICMR and
    state as well as local government bodies.

    Vaccination doesn’t protect against SARS CoV 2 reinfection although vaccination may prevent against
    development of severe disease. Such cases of reinfection post vaccination may be detected by SARS
    CoV 2 RTPCR irrespective of symptoms.

    ICMR registration no. MHLP001

    Interpretation guidelines

    A. For result as “DETECTED”:


    1) Detected result indicates presence of SARS-CoV-2.
    2) Each “Detected” result has been verified using confirmatory test.
    3) False positive is rare globally.

    Dr. Manish Karekar


    MD ( Pathology) Chief of Lab Services
    Page 1 of 3
    Mr. VILAS DHAVALE Reference: Dr.SELF VID: 116211549004609
    SR NO 19/6/2 LEN NO 17/8 RAIKAR NAGAR Client Address: Registered On:
    DHAYARI, HAVELI Mrs manjiri mahesh shirolkar 30/04/2021 11:01 AM
    Tel No : 9763731388 Office at 11, laxmi narayan maruti,-opp. Collected On:
    PIN No: 411041 p.l. deshpande garden,-sinhgadh road,
    30/04/2021 11:01AM
    pune 411030
    PID NO: P1162100291582 Reported On:
    PROCESSING LOCATION:- Metropolis
    Age: 52.0 Year(s) Sex: Male Healthcare Ltd. Bhandarkar Road, 01/05/2021 08:16 AM
    Pune - 411004

    4) A repeat test of freshly collected specimen may give different result due to the following –
    a. From appearance of symptoms, Viral load reduces day by day and one may clear virus as early
    as 4.3 days¹. As viral load reduces during recovery/resolution, the result of repeat testing, even
    within hours or day/s, can yield different results.
    b. The new sample may have low viral load due to varied shedding of the virus.
    c. Inherent variability due to improper sample collection and inadequate storage while due care is
    taken at Metropolis.
    5) 80% of patients with “Detected” result may be asymptomatic.
    6) A detected result does not distinguish between a viable/replicating organism and a non-viable organism
    B. For result as “NOT DETECTED”:
    1) “Not Detected” result indicates absence of SARS-CoV-2 in the given specimen. However, it does not
    rule out the infection completely and should not be used as the sole basis for making decisions related
    to treatment and other patient management decisions.
    2) “Not detected” result may be seen due to -
    a. RT PCR done on Nasopharyngeal swab having 44% false negativity.
    b. Test done too early or too late where the virus load is below detection limit.
    c. Improperly collected and stored specimen.
    d. Viral mutations
    3) If a subsequent test is tested positive (detected), it may indicate an infection acquired subsequently or
    increase in viral load to detectable level after the first test.

    Disclaimers:
    1. RNA viruses like SARS-CoV-2 (COVID 19) have a lot of genetic variability and it’s possible that certain virus
    detection kits test cannot detect some strains of the viruses. Although efforts were made by manufacturers
    of the diagnostic kits to design the test assays that target the parts of viral genome which are shared by all
    the different circulating viral strains, there still might be some mismatch between the primers and the probes
    used in the test and the target regions within the viruses.
    2. Sensitivity of this test results depends upon the quality of the sample submitted for testing, stage of
    infection, type of the specimen collected for testing, medical history and clinical presentation.
    3. All approved kits being used also may have different positive and negative predictive values leading to
    mismatch of results.
    4. A careful consideration to combination of epidemiological factors, stage of infection, clinical history,
    examination, other relevant investigation findings and treatment history should be done when interpreting
    test results.
    5. Current knowledge about novel coronaviruses is evolving and more studies may be required for further
    evaluation and review of facts indicated in this report.

    Patient Instructions:
    • Kindly consult referring Physician/ Authorized Govt. hospital for appropriate follow up.
    • Details of all the positive patients will be communicated to Epidemiology Cell whom you are requested to
    support.
    • “Detected” status needs to be notified to the appropriate authorities as per the existing rules/regulations,
    while we shall also be doing the same.

    Dr. Manish Karekar


    MD ( Pathology) Chief of Lab Services
    Page 2 of 3
    Mr. VILAS DHAVALE Reference: Dr.SELF VID: 116211549004609
    SR NO 19/6/2 LEN NO 17/8 RAIKAR NAGAR Client Address: Registered On:
    DHAYARI, HAVELI Mrs manjiri mahesh shirolkar 30/04/2021 11:01 AM
    Tel No : 9763731388 Office at 11, laxmi narayan maruti,-opp. Collected On:
    PIN No: 411041 p.l. deshpande garden,-sinhgadh road,
    30/04/2021 11:01AM
    pune 411030
    PID NO: P1162100291582 Reported On:
    PROCESSING LOCATION:- Metropolis
    Age: 52.0 Year(s) Sex: Male Healthcare Ltd. Bhandarkar Road, 01/05/2021 08:16 AM
    Pune - 411004

    Clinical Background:
    COVID-19 is a new disease, caused by a novel (or new) coronavirus SARS-CoV-2. Reported illnesses have
    ranged from mild symptoms to severe illness and death for confirmed COVID-19 cases. Symptoms like Fever,
    Cough, and Shortness of breath may appear 2-14 days after exposure. The virus is thought to spread mainly
    from person-to-person, between people who are in close contact and through respiratory droplets. It can also
    spread from contact with infected surfaces or objects.
    References:
    1. Tao Ai et al. Correlation of Chest CT and RT-PCR Testing in Coronavirus Disease 2019 (COVID-19) in China:
    A Report of 1014 Cases
    2. Yang et al. Evaluating the accuracy of different respiratory specimens in the laboratory diagnosis and
    monitoring the viral shedding of 2019-nCoV infections.

    Abbreviations
    ICMR : Indian Council of Medical Research

    -- End of Report --

    Dr. Manish Karekar


    MD ( Pathology) Chief of Lab Services
    Page 3 of 3

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