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A Negative result does not preclude SARS-CoV-2 and should not be used as the sole basis for patient management
decisions. In clinically suspected patients and those who had contact with a known positive patient, it is advisable to retest
in a fresh sample after 48 to 72 hours. (Clinical Sensitivity of the test is 60-80% )
A Positive result comes after thorough check of the controls , Each batch Validity ensured in addition to validating each Kit
prior to clinical diagnostic use . The analytical sensitivity of the assay is 95 % .Therefore , false positives are ruled out by all
means .
ICMR ID : 433829833
Note :
• ICMR Recommended kits are used for reporting . All the Positive cases will be notified to ICMR for further
Surveillance .
• Borderline positive cases (Ct Value > 30) may give variable results on repeat testing . The possible reasons could be
the variations in the kits and instruments used.
• Clinical correlation with patient history , radiology findings and co-infection with other viruses is essential for
individual case management . Ct values will not be shared in this test as it is a qualitative test and subjective to various
parameters . Ct values has no correlation with severity and has no implications on patient management .
Reference :
• Labcorp COVID-19 RT-PCR test EUA Summary / COVID -19 RT-PCR test (laboratory corporation of America).
** End of Report **