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RTqPCR Covid Test Kit (Pack of 100)

46000.00

Company Svashmi
SKU BISICOVIDTEST
product details

* The single-gene amplification or even random positive results is suggestive of:

a) Low amount of RNA template of the sample near or below the detection limit of the reactions

b) Mutations in the nucleic acid sequences targeted.

c) Slightly different amplification yield of the targets regions,

d) Due to differential sensitivity of the target genes and due to multiplex format of assay, in rare cases, weak positive samples may show signal in either of targets.

Or

e) Other factors.

 

  • A sample is considered positive if the Ct value obtained is less than or equal to 40 and the internal control (RNase P) shows or not shows an amplification signal. Sometimes, the detection of internal control is not necessary because a high copy number of target can cause preferential amplification of target-specific nucleic acids.

 

  • A sample is considered negative, if the sample shows no amplification signal in the detection system but the internal control is positive. An inhibition of the PCR reaction can be excluded by the amplification of internal control. In case of a continued ambiguous result, it is recommended to verify the correct performance of each of the steps and review the parameters and the sigmoid shape of the curve. It is also recommended to repeat the assay, preferably in duplicate. The result of the test should be evaluated by a health care professional in the context of medical history, clinical symptoms and other diagnostic tests.

 

LIMITATIONS OF THE TEST

 

  • The results of the test should be evaluated by a health care professional in the context of medical history, clinical symptoms and other diagnostic tests. Although this assay can be used with other types of samples it has been validated only with RNA extracted from respiratory samples (nasopharyngeal swab and oropharyngeal swab).

 

  • The quality of the test depends on the quality of the sample; proper extracted nucleic acid from clinical samples must be extracted.
  • Extremely low levels of target below the limit of detection might be detected, but results may not be reproducible.
  • There is a possibility of false positive results due to cross-contamination by SARS-CoV-2, either samplesØ containing high concentrations of target RNA or contamination due to PCR products from previous reactions.
  • The specific primer and probe combinations for detection of the ORF1ab, E and N genes used in in the Kit designed for the detection of SARS-CoV-2, do not show significant combined homologies with the human genome, human microflora, SARS-CoV or other coronaviruses (with the exception of some N gene sequences from coronaviruses identified in bats and pangolin), which might result in predictable false positive.
  • False Negative results may arise from several factors and their combinations, including: ImproperØ specimens’ collection, transport, storage, and/or handling methods.
  • Improper processing procedures (including RNA extraction).
  • Degradation of the viral RNA during sample shipping/storage and/or processing.
  • Mutations or polymorphisms in primer or probe binding regions may affect detection of new or unknown SARSCoV-2 variants.
  • A viral load in the specimen below the limit of detection for the assay
  • The presence of RT-qPCR inhibitors or other types of interfering substances. The impacts of vaccines, antiviral therapeutics, antibiotics, and chemotherapeutics or immunosuppressant drugs used to prevent COVID-19 or used during the treatment of the infection have not been evaluated.
  • Failure to follow instructions for use and the assay procedure.

In case of a doubt, it is recommended referring to a reference laboratory for further testing.

  • A positive test result does not necessarily indicate the presence of viable viruses and does not imply that theseØ viruses are infectious or are the causative agents for clinical symptoms. However, a positive result is indicative of the presence of targets viral sequences (ORF1ab, E and/or N genes).
  • Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for treatment or other patient management decisions. Optimum specimen types and timing for peak viral levels during infections caused by SARS-CoV-2 have not been determined. The collection of multiple specimens (types and time points) from the same patient may be necessary to detect the virus
  • If diagnostic tests for other respiratory illnesses are negative and the patient’s clinical presentation andØ epidemiological information suggest that SARS-CoV-2 infection is possible, then a false negative result should be considered, and a re-testing of the patient should be discussed

 

             . QUALITY CONTROL

 Stellence Covid-19 RT-qPCR Kit should always be used along with positive and a negative                    control in each run to correctly interpret the results. Also, the internal control (RNase P) in each well confirms the correct performance of the PCR and presence of RNA template in sample. In accordance with Stellence quality systems, each lot of kit is tested against identified specifications to ensure consistent product quality.

* The single-gene amplification or even random positive results is suggestive of:

a) Low amount of RNA template of the sample near or below the detection limit of the reactions

b) Mutations in the nucleic acid sequences targeted.

c) Slightly different amplification yield of the targets regions,

d) Due to differential sensitivity of the target genes and due to multiplex format of assay, in rare cases, weak positive samples may show signal in either of targets.

Or

e) Other factors.

 

  • A sample is considered positive if the Ct value obtained is less than or equal to 40 and the internal control (RNase P) shows or not shows an amplification signal. Sometimes, the detection of internal control is not necessary because a high copy number of target can cause preferential amplification of target-specific nucleic acids.

 

  • A sample is considered negative, if the sample shows no amplification signal in the detection system but the internal control is positive. An inhibition of the PCR reaction can be excluded by the amplification of internal control. In case of a continued ambiguous result, it is recommended to verify the correct performance of each of the steps and review the parameters and the sigmoid shape of the curve. It is also recommended to repeat the assay, preferably in duplicate. The result of the test should be evaluated by a health care professional in the context of medical history, clinical symptoms and other diagnostic tests.

 

LIMITATIONS OF THE TEST

 

  • The results of the test should be evaluated by a health care professional in the context of medical history, clinical symptoms and other diagnostic tests. Although this assay can be used with other types of samples it has been validated only with RNA extracted from respiratory samples (nasopharyngeal swab and oropharyngeal swab).
  • The quality of the test depends on the quality of the sample; proper extracted nucleic acid from clinical samples must be extracted.
  • Extremely low levels of target below the limit of detection might be detected, but results may not be reproducible.
  • There is a possibility of false positive results due to cross-contamination by SARS-CoV-2, either samplesØ containing high concentrations of target RNA or contamination due to PCR products from previous reactions.
  • The specific primer and probe combinations for detection of the ORF1ab, E and N genes used in in the Kit designed for the detection of SARS-CoV-2, do not show significant combined homologies with the human genome, human microflora, SARS-CoV or other coronaviruses (with the exception of some N gene sequences from coronaviruses identified in bats and pangolin), which might result in predictable false positive.
  • False Negative results may arise from several factors and their combinations, including: ImproperØ specimens’ collection, transport, storage, and/or handling methods.
  • Improper processing procedures (including RNA extraction).
  • Degradation of the viral RNA during sample shipping/storage and/or processing.
  • Mutations or polymorphisms in primer or probe binding regions may affect detection of new or unknown SARSCoV-2 variants.
  • A viral load in the specimen below the limit of detection for the assay
  • The presence of RT-qPCR inhibitors or other types of interfering substances. The impacts of vaccines, antiviral therapeutics, antibiotics, and chemotherapeutics or immunosuppressant drugs used to prevent COVID-19 or used during the treatment of the infection have not been evaluated.
  • Failure to follow instructions for use and the assay procedure.

In case of a doubt, it is recommended referring to a reference laboratory for further testing.

  • A positive test result does not necessarily indicate the presence of viable viruses and does not imply that theseØ viruses are infectious or are the causative agents for clinical symptoms. However, a positive result is indicative of the presence of targets viral sequences (ORF1ab, E and/or N genes).
  • Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for treatment or other patient management decisions. Optimum specimen types and timing for peak viral levels during infections caused by SARS-CoV-2 have not been determined. The collection of multiple specimens (types and time points) from the same patient may be necessary to detect the virus
  • If diagnostic tests for other respiratory illnesses are negative and the patient’s clinical presentation andØ epidemiological information suggest that SARS-CoV-2 infection is possible, then a false negative result should be considered, and a re-testing of the patient should be discussed

 . QUALITY CONTROL

 Stellence Covid-19 RT-qPCR Kit should always be used along with positive and a negative control in each run to correctly interpret the results. Also, the internal control (RNase P) in each well confirms the correct performance of the PCR and presence of RNA template in sample. In accordance with Stellence quality systems, each lot of kit is tested against identified specifications to ensure consistent product quality.

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