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Department of Molecular Biology. Covid 19 RT PCR With Home Collection Test Name Result Unit Bio. Ref. Range Method

The document contains COVID-19 RT-PCR test results for two patients, Baby Aanya Mishra and Mr. Anurag Mishra, both of whom tested positive for SARS-CoV-2 with specific CT values indicating the presence of the virus. It includes details on the testing method, interpretation of results, and notes on the variability of CT values and potential for false results. The report emphasizes the need for clinical correlation and further testing if necessary.
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0% found this document useful (0 votes)
15 views6 pages

Department of Molecular Biology. Covid 19 RT PCR With Home Collection Test Name Result Unit Bio. Ref. Range Method

The document contains COVID-19 RT-PCR test results for two patients, Baby Aanya Mishra and Mr. Anurag Mishra, both of whom tested positive for SARS-CoV-2 with specific CT values indicating the presence of the virus. It includes details on the testing method, interpretation of results, and notes on the variability of CT values and potential for false results. The report emphasizes the need for clinical correlation and further testing if necessary.
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 6

Patient Name : Baby.

AANAYA MISHRA Collected : 11/Feb/2022 08:45AM


Age/Gender : 6 Y 0 M 0 D /F Received : 11/Feb/2022 02:16PM
UHID/MR No : DATP.0000006420 Reported : 11/Feb/2022 06:09PM
Visit ID : DATPOPV19815 Status : Final Report
Ref Doctor : Dr.SELF Client Name : PCC ATTAPUR HYDERABAD
IP/OP NO : Patient location : Attapur new friend colony,Hyderabad

DEPARTMENT OF MOLECULAR BIOLOGY.


COVID 19 RT PCR WITH HOME COLLECTION
Test Name Result Unit Bio. Ref. Range Method

COVID-19(SARS-CoV 2)-REAL TIME PCR(RT-PCR)


SAMPLE TYPE PHARYNGEAL
SWAB
SARS-CoV-2 DETECTED
N-Gene CT VALUE 30
ORF1ab Gene CT VALUE 31

Comment:
Biological Reference Rang
*Ct value < 35 is Positive
*Ct value >35 is Negative

*Ct cutoff suggested by ICMR


Ct value does not correlate with
disease severity

Please Note:
*CT values vary with the type of kit used, the types of samples collected and the various pre-analytical factors.
*The published studies are conflicting to definitively prove a direct correlation between disease severity/infectiousness and CT
values therefore; relying on CT values for determining infectiousness of COVID-19 patients and deciding management protocols
is left to clinical discretion.

Kit used: CoviPath ™ COVID-19 RTPCR KIT

Result Interpretation
Indicates presence of detectable levels
Detected (Positive) Result
SARS-CoV-2 specific RNA (ORF1ab gene and/ or N gene) in patient’s sample.

Indicates absence of detectable levels


Not Detected (Negative) Result
SARS-CoV-2 specific RNA (ORF1ab gene and/ or N gene) in patient’s sample.

Indicates the target concentration is too low, or presence of interfering substances


Indeterminate Result
leading to PCR inhibition.

NOTE:

Page 1 of 3
Patient Name : Baby.AANAYA MISHRA Collected : 11/Feb/2022 08:45AM
Age/Gender : 6 Y 0 M 0 D /F Received : 11/Feb/2022 02:16PM
UHID/MR No : DATP.0000006420 Reported : 11/Feb/2022 06:09PM
Visit ID : DATPOPV19815 Status : Final Report
Ref Doctor : Dr.SELF Client Name : PCC ATTAPUR HYDERABAD
IP/OP NO : Patient location : Attapur new friend colony,Hyderabad

DEPARTMENT OF MOLECULAR BIOLOGY.


COVID 19 RT PCR WITH HOME COLLECTION
Test Name Result Unit Bio. Ref. Range Method

If either of the genes cannot be determined or will give indeterminate results, further testing maybe required using another kit
with a different primer and probe.
A Not Detected (Negative) Resultdo not preclude SARS-CoV-2 and should not be used as the sole basis for patient
management decisions. Kindly repeat test after 48 to 72 hrs if clinically suspected.
Lower respiratory tract specimens are more representative and are preferred.
If at a later date, suspicion of COVID-19 is strong, a fresh sample for Real Time PCR after a gap of 2-4 days after collection
of first sample maybe considered.
Please contact your Physician for necessary action to be taken and to limit the spread of infection.
Clinical Correlation and Correlation with the history of the patient is required before arriving at any conclusion. Presence of
Non-Specific interfering substances during this assay to be kept in mind. Please correlate clinically before arriving at any
conclusion.
False positive and false negative results can be due to multiple factors including sampling technique, transport & interference in
the assay can affect the result.
Presence PCR inhibitors in sample may lead to false negative or invalid results.
Mutation in the target sequence of SARS-CoV-2 or change in the sequence due to virus evolution may lead to false negative
results.
Invalid Result: There is no typical S-shape amplification curve or Ct >35 or No Ct detected for target genes and internal
control, indicating the specimen concentration is too low, or there are interfering substances that inhibit the reaction. If upon
retest, the result is invalid again, another fresh sample should be collected and tested.

SARS-CoV-2 Virus:

SARS-CoV-2 is an enveloped single stranded positive sense RNA virus belongs to family Coronoviridae. It carries largest single
stranded RNA genome of ~30kb and is the causative pathogen of ongoing COVID-19 pandemic (3). The capsid consists of the
nucleocapsid protein N and this is further surrounded by a membrane, that contains three proteins: the membrane protein (M) and the
envelope protein (E), which are involved in the virus budding process, and the spike glycoprotein (S), which is a key player in binding
host receptor and mediating membrane fusion and virus entry into host cells (4).

Page 2 of 3
Patient Name : Baby.AANAYA MISHRA Collected : 11/Feb/2022 08:45AM
Age/Gender : 6 Y 0 M 0 D /F Received : 11/Feb/2022 02:16PM
UHID/MR No : DATP.0000006420 Reported : 11/Feb/2022 06:09PM
Visit ID : DATPOPV19815 Status : Final Report
Ref Doctor : Dr.SELF Client Name : PCC ATTAPUR HYDERABAD
IP/OP NO : Patient location : Attapur new friend colony,Hyderabad

DEPARTMENT OF MOLECULAR BIOLOGY.


COVID 19 RT PCR WITH HOME COLLECTION
Test Name Result Unit Bio. Ref. Range Method

Disclaimer:
This Test is based on real-time reverse transcriptase PCR technology for the qualitative detection of severe acute respiratory
syndrome coronavirus 2 (SARS-CoV-2) specific RNA

*ICMR ID- DLUAHTMH-


*ICMR ID-AHLLBHT- HYDERABAD *ICMR ID-AHLVDLA- VIJAYAWADA
MUMBAI
*ICMR ID-ADNTKLKWB -
*ICMR ID-AHLLKDLKAP- KURNOOL *ICMR ID-AHLLDLDD-DELHI
KOLKATA
*ICMR ID-APHLILKDLCTN-
*ICMR ID-AHLLKDIALBK- BENGALURU *ICMR ID-AHHHSPPMH- PUNE
CHENNAI
*ICMR ID-APHLTHLFLADLCK-
LUCKNOW

(For kits determining RdRp gene or ORF1b, sensitivity / specificity of such kits shall be mentioned).

COVID-19 Advisory

*** End Of Report ***

Page 3 of 3

SIN No:MO02307166
This test has been performed at Apollo Health & Lifestyle Ltd, Global Reference Laboratory,Hyderabad
Patient Name : Mr.ANURAG MISHRA Collected : 11/Feb/2022 08:44AM
Age/Gender : 33 Y 0 M 0 D /M Received : 11/Feb/2022 02:16PM
UHID/MR No : DATP.0000006419 Reported : 11/Feb/2022 06:09PM
Visit ID : DATPOPV19816 Status : Final Report
Ref Doctor : Dr.SELF Client Name : PCC ATTAPUR HYDERABAD
IP/OP NO : Patient location : Attapur new friend colony,Hyderabad

DEPARTMENT OF MOLECULAR BIOLOGY.


COVID 19 RT PCR WITH HOME COLLECTION
Test Name Result Unit Bio. Ref. Range Method

COVID-19(SARS-CoV 2)-REAL TIME PCR(RT-PCR)


SAMPLE TYPE PHARYNGEAL
SWAB
SARS-CoV-2 DETECTED
N-Gene CT VALUE 19
ORF1ab Gene CT VALUE 20

Comment:
Biological Reference Rang
*Ct value < 35 is Positive
*Ct value >35 is Negative

*Ct cutoff suggested by ICMR


Ct value does not correlate with
disease severity

Please Note:
*CT values vary with the type of kit used, the types of samples collected and the various pre-analytical factors.
*The published studies are conflicting to definitively prove a direct correlation between disease severity/infectiousness and CT
values therefore; relying on CT values for determining infectiousness of COVID-19 patients and deciding management protocols
is left to clinical discretion.

Kit used: CoviPath ™ COVID-19 RTPCR KIT

Result Interpretation
Indicates presence of detectable levels
Detected (Positive) Result
SARS-CoV-2 specific RNA (ORF1ab gene and/ or N gene) in patient’s sample.

Indicates absence of detectable levels


Not Detected (Negative) Result
SARS-CoV-2 specific RNA (ORF1ab gene and/ or N gene) in patient’s sample.

Indicates the target concentration is too low, or presence of interfering substances


Indeterminate Result
leading to PCR inhibition.

NOTE:

Page 1 of 3
Patient Name : Mr.ANURAG MISHRA Collected : 11/Feb/2022 08:44AM
Age/Gender : 33 Y 0 M 0 D /M Received : 11/Feb/2022 02:16PM
UHID/MR No : DATP.0000006419 Reported : 11/Feb/2022 06:09PM
Visit ID : DATPOPV19816 Status : Final Report
Ref Doctor : Dr.SELF Client Name : PCC ATTAPUR HYDERABAD
IP/OP NO : Patient location : Attapur new friend colony,Hyderabad

DEPARTMENT OF MOLECULAR BIOLOGY.


COVID 19 RT PCR WITH HOME COLLECTION
Test Name Result Unit Bio. Ref. Range Method

If either of the genes cannot be determined or will give indeterminate results, further testing maybe required using another kit
with a different primer and probe.
A Not Detected (Negative) Resultdo not preclude SARS-CoV-2 and should not be used as the sole basis for patient
management decisions. Kindly repeat test after 48 to 72 hrs if clinically suspected.
Lower respiratory tract specimens are more representative and are preferred.
If at a later date, suspicion of COVID-19 is strong, a fresh sample for Real Time PCR after a gap of 2-4 days after collection
of first sample maybe considered.
Please contact your Physician for necessary action to be taken and to limit the spread of infection.
Clinical Correlation and Correlation with the history of the patient is required before arriving at any conclusion. Presence of
Non-Specific interfering substances during this assay to be kept in mind. Please correlate clinically before arriving at any
conclusion.
False positive and false negative results can be due to multiple factors including sampling technique, transport & interference in
the assay can affect the result.
Presence PCR inhibitors in sample may lead to false negative or invalid results.
Mutation in the target sequence of SARS-CoV-2 or change in the sequence due to virus evolution may lead to false negative
results.
Invalid Result: There is no typical S-shape amplification curve or Ct >35 or No Ct detected for target genes and internal
control, indicating the specimen concentration is too low, or there are interfering substances that inhibit the reaction. If upon
retest, the result is invalid again, another fresh sample should be collected and tested.

SARS-CoV-2 Virus:

SARS-CoV-2 is an enveloped single stranded positive sense RNA virus belongs to family Coronoviridae. It carries largest single
stranded RNA genome of ~30kb and is the causative pathogen of ongoing COVID-19 pandemic (3). The capsid consists of the
nucleocapsid protein N and this is further surrounded by a membrane, that contains three proteins: the membrane protein (M) and the
envelope protein (E), which are involved in the virus budding process, and the spike glycoprotein (S), which is a key player in binding
host receptor and mediating membrane fusion and virus entry into host cells (4).

Page 2 of 3
Patient Name : Mr.ANURAG MISHRA Collected : 11/Feb/2022 08:44AM
Age/Gender : 33 Y 0 M 0 D /M Received : 11/Feb/2022 02:16PM
UHID/MR No : DATP.0000006419 Reported : 11/Feb/2022 06:09PM
Visit ID : DATPOPV19816 Status : Final Report
Ref Doctor : Dr.SELF Client Name : PCC ATTAPUR HYDERABAD
IP/OP NO : Patient location : Attapur new friend colony,Hyderabad

DEPARTMENT OF MOLECULAR BIOLOGY.


COVID 19 RT PCR WITH HOME COLLECTION
Test Name Result Unit Bio. Ref. Range Method

Disclaimer:
This Test is based on real-time reverse transcriptase PCR technology for the qualitative detection of severe acute respiratory
syndrome coronavirus 2 (SARS-CoV-2) specific RNA

*ICMR ID- DLUAHTMH-


*ICMR ID-AHLLBHT- HYDERABAD *ICMR ID-AHLVDLA- VIJAYAWADA
MUMBAI
*ICMR ID-ADNTKLKWB -
*ICMR ID-AHLLKDLKAP- KURNOOL *ICMR ID-AHLLDLDD-DELHI
KOLKATA
*ICMR ID-APHLILKDLCTN-
*ICMR ID-AHLLKDIALBK- BENGALURU *ICMR ID-AHHHSPPMH- PUNE
CHENNAI
*ICMR ID-APHLTHLFLADLCK-
LUCKNOW

(For kits determining RdRp gene or ORF1b, sensitivity / specificity of such kits shall be mentioned).

COVID-19 Advisory

*** End Of Report ***

Page 3 of 3

SIN No:MO02307172
This test has been performed at Apollo Health & Lifestyle Ltd, Global Reference Laboratory,Hyderabad

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