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CENTRAL FACILITY
BUDH MARG PATNA
800 001
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Laboratory Medicine for a 40 NEW CIT
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ANALYSIS REPORT ACCESSION #
FOR CLINICAL ASSESSMENT BY A MEDICAL SPECIALIST APR 15 2021
ONLY
IIIIIIIHIIIIIIII
OTHERS DO NOT TRY TO INFER A CUNICAL STATE FROM LAB DATA 17:00
SARS-CoV-2 Qualitative RT-PCR Test: Real Time Reverse Transcription Polymerase Chain Reaction protocol employed is based on * The ICMR has issued a Negative Recommendation against using Cycle
Taqman chemistry for detection of SARS-CoV-2 RNA in human NP/OP/BAL specimen from the Upper Respiratory Tract. Viral RNA is Threshold value for determining infectiousness & deciding patient
first extracted and converted into complementary DNA (cDNA) by the RT enzyme followed by thermal cycling. Positive amplification management protocols citing:
causes the dual labeled fluorescent probe to release fluorophores in an exponential manner which is captured on a real time basis. The
Cycle threshold (Ct) is the number of amplification cycles required for the fluorescent signal to cross the threshold. An internal positive • Although, theoretically the CT value is inversely proportional to the
control (IPC), validates each test through a full process control that checks all steps - from extraction to amplification thereby validating amount of RNA in the source URT swab of this QUALITATIVE
the test from quality of sample to intregrity of result. test; there is no reliable evidence of any direct correlation
between disease severity or infectiousness & CT value
1. A POSITIVE result indicates presence of SARS-CoV-2 RNA in the specimen tested • Studies have shown that guiding clinical decision based on CT
° Clinical correlation with patient history & other diagnostic information is necessary to determine infection ststus values of RT-PCR test has several limitations eg: the amount of
° Positive results do not rule out co-infection other bactaeria or viruses genetic material collected in URT swab unlike blood is quite
2. A NEGATIVE result DOES NOT exclude SARS-CoV-2 infection particularly if tested before onset of symptoms. Result must variable. CT will thus not reflect true viral load. Besides, observed
be combined with clinical observations, patient-history, & epidemiological information value will depend on multiple factors - Quality & Type of swab,
3. INCONCLUSIVE result may be encountered occasionally Type of VTM, Target gene used by different PCR methods, host
° Indicating that the test detected only one nucleic acid target common to SARS but not the specific targets to immune factors etc.
confirm SARS-CoV-2. A repeat test with a fresh sample will be required as soon as possible i.e. during the
acute phase
o ASSAYEDWTTH ACCREDITED PROTOCOLS & SYSTEMS FROM ABBOTT, BD, BECKMAN-COULTER, BIO-RAD, OLYMPUS O CROSS-PROTOCOL REFERENCING NOT POSSIBLE * PLEASE CONTACT FOR ANY CLARIFICATION
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