Anil Singh RTPCR
Anil Singh RTPCR
Anil Singh RTPCR
CLIENTCODE :C000089500
CLINICAL INFORMATION :
MOLECULAR BIOLOGY
SARS COV -2 REAL TIME PCR
Comments
Interpretation(s)
SARS COV -2 REAL TIME PCR-SARS-CoV-2, formerly known as 2019-nCoV, is the causative agent of the coronavirus disease 2019 (COVID-19). Main symptoms of the
disease include fever, cough and shortness of breath. SARS-CoV-2 transmission occurs primarily via respiratory droplets. SARS-CoV-2 is likely to be at the highest
concentrations in the nasopharynx during the first 3 to 5 days of symptomatic illness. Real Time PCR assay targets specific genes and can be used for diagnosis of
SARS-CoV-2 virus infection.
Positive result indicates that RNA from SARS-CoV-2 was detected in the specimen, and the patient is considered infected with the virus and presumed to be contagious.
Negative test result for this test means that SARS-CoV-2 RNA was not detected in the specimen
Limitations:
• Negative results do not preclude COVID-19 and must be correlated with clinical observations, patient history, and epidemiological information.
• Positive results do not rule out bacterial infection or co-infection with other viruses.
• The sensitivity of the assay is dependent on the timing of the specimen collection (in relation to symptom onset/stage of infection), quality, and type of the specimen
submitted for testing
• Follow-up testing may particularly be important if patient has a clinical picture of viral pneumonia, a potential exposure history, and/or radiographic findings (chest CT or
MRI scan) consistent with COVID -19 pneumonia. However repeat testing in the near-term after clearance (within 90 days) should be avoided as prolonged shedding of
non-viable virus is not uncommon
• Ct values generated from different assay systems within the same laboratory, or from different laboratories, are not directly comparable and do not necessarily reflect the
same viral load due to inter-assay and inter-laboratory variability.
• Variation in timing of sample collection, fluctuations in virus shedding, and difference between detection limit of different testing methods within same or different labs
could lead to variation in results particularly during initial phase of infection.
• If the virus mutates in the rRT-PCR target region, 2019-nCoV may not be detected or may be detected less predictably. Inhibitors or other types of interference may
produce a false negative result.
• The performance of this test has not been established for monitoring treatment of 2019-nCoV infection.
Note: Test is performed using ICMR approved Kit targeting any of these genes – E/RDRP/N/ORF1AB
References:
1. Euro Surveill 2020 25, 2. Druce et al. JCM. 2011, 3. N. Engl. J. Med. 2020, 382, 929–936
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CLIENTCODE :C000089500
CLINICAL INFORMATION :
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