Molecular Laboratory: Kit Specification Pathodetect Covid19 Qualitative PCR Kit, CT Cutoff - 37

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Patient Name : MR.

VIRAJ G Patient ID :F/2262/22


Age / Gender : 16 years / Male Collection Time : Feb 01, 2022, 01:14 p.m.
Referral : - Reporting Time : Feb 01, 2022, 05:19 p.m.
Source : HELP DESK Sample ID :

Address :
220320195

Investigations Result(s)

MOLECULAR LABORATORY

Result SARS-CoV-2: Not Detected (Negative)


Kit Specification PathoDetect Covid19 Qualitative PCR Kit , CT cutoff-<37

ICMR Registration No. 668664556


ICMR Registration No.
Specimen: Throat swab + Nasal swab in VTM
Method: Real time RT-PCR
Note:
• ICMR recommended kits are used for reporting. All the positive cases will be notified to ICMR for further surveillance.

• Clinical correlation with patient history, radiology findings and co-infection with other virus infection is necessary to be determined.

• Borderline positive cases (CT Value >30) may give variable results on repeat testing. The possible reasons could be the variation in kits and instrument used.

Limitations:
• Optimum specimen types and timing of peak viral levels during infections caused by 2019-nCOV have not been determined. Collection of multiple specimens (Types & Time points) may be necessary in view of

suspected clinical history. The repeat specimen may be considered after a gap of 2-4 days after the collection of first specimen for additional testing if required.

• Negative results do not preclude SARS - CoV - 2 infection and should not be used as the sole basis for patient management decisions.

• This test is a qualitative assay and does not quantify viral load. Various host factors, viral factors, variability in sample collection /sites and techniques used by the Lab can affect Ct values.Therefore CT values

are not an absolute indication of viral load and should be interpreted with caution.

Factors leading to false negative RT-PCR report:


• Inadequate specimen collection, Poor quality of the sample, and non-representative sample.

• Sample collected too early or too late in the infection, Improper sample handling and shipment.

• Technical reasons- PCR Inhibitor, the analytical sensitivity of kit used.

• Active recombination &/ mutations in target genes used for detection of SARS-CoV-2 virus.

References:
1. Diagnostic detection of 2019-nCoV by real-time RT-PCR, Berlin Jan 17th, 2020.

2.The PathoDetect COVID-19 Qualitative PCR Kit insert.

* Sample processed at Molecular Lab Pathology Department of JRH Mumbai Central

**END OF REPORT**

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