DOB : NA
REAL TIME QUALITATIVE RT PCR DETECTION OF SARS-COV-2 / COVID 19
SPECIMEN : NASOPHARYNGEAL AND OROPHARYNGEAL SWAB
METHOD : Real time Reverse Transcriptase PCR using commercially available ICMR approved kit (Taqman probe based)
KIT SPECIFICATION : Meril COVID-19 One Step RT-PCR kit.
CLINICAL INTERPRETATION : The given test detects RNA of SARS-CoV-2 virus in submitted clinical sample, where in ORF1ab & N gene is the targetfor detection.
REMARKS :
1) A detected result is considered as positive and is indicative of the presence of SARS -CoV-2 infection. Clinical correlation with patient history and other diagnostic information is necessary to determine patient
infection status.
2) Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease
3) A not detected result means that SARS-CoV 2 RNA was not present in the specimen above the limit of detection . However, improper sample collection, handling, storage and transportation may result in false negative
result. The report represents only the specimen received in laboratory.
LIMITATIONS :
1) Presence of PCR inhibitor may interfere with PCR amplification.
2) Negative results do not rule out possibility of SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Presence of inhibitors, mutations and insufficient organism RNA can
influence the result .
3) Positive result does not distinguish between viable and non-viable virus
4) Viral load/shedding may differ at the beginning and towards the end of infection in an individual , thus repeat testing done on different days may show different results.
5) The test is a qualitative assay and is not recommended by ICMR to quantify viral load due to several technical issues.
6) Various ICMR approved kits may have differences in test sensitivity , specificity and cut off values for PCR cycles, thus may result in difference of results.
7) Research studies are continually updating the knowledge about SARS -CoV 2 and should be considered while review of this report
