Zena Max SARS-CoV-2 Direct qPCR Detection Kit CE/IVD
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You are enquiring about Zena Max SARS-CoV-2 Direct qPCR Detection Kit CE/IVD
An innovative, accurate and time-effective system for the detection of Covid-19
One Step Real-Time PCR Technology
Compatible with most common Real-Time PCR equipment
Intended Use
This assay is a Real-Time in vitro PCR test for the qualitative identification of the novelSevere Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2/COVID-19). It enables the direct amplification and identification of SARS-CoV-2 from human samples such asnasopharyngeal, nasal, oropharyngeal swabs. It is based on the hydrolysis probe detection method and is a highly sensitive one-step RT-qPCR kit. With the help of different coloredchannels producing signals, the sample can be positive or negative.
For in vitro diagnostic use.
Sample Type
human samples like nasopharyngeal swabs (NPS), nasal swabs, nasal wash or aspirate or bronchoalveolar lavage (BAL)
Target
ORF1 ab gene and N gene
Sensitivity
The Zena Max COVID-19 qPCR kit is highly sensitive, able to detect a minimum of 10 copies per reaction under our validation methods and devices.
Specificity
The analytical specificity study was carried out by in silico analysis shows that the AMD SARS-CoV-2 assays 100% sequence identity to 769 out of the 773 (99.4%) SARS-CoV-2 genomes available in the public databases, however, there is no cross-reactivity with any other coronavirus sequenced or the most common respiratory pathogens thus far.
Clinical Performance
The clinical performance of Zena Max SARS-CoV-2 Real Time PCR Detection kit was tested using clinical specimens in transport medium. 174 individual negative nasopharyngeal specimens and a total of 18 positive clinical samples tested with a validated molecular comparator assay.
Low positive contrived clinical samples were prepared by spiking a quantified clinical sample into individual negative clinical samples to approximately 30 samples.
All clinical samples were collected from patients with signs and symptoms of upper respiratory infection by qualified personnel according to the package insert of the collection device and stored frozen until use.
These results were compared with those obtained with a molecular detection method.
Result: 100% sensitivity
Instrument compatibility
AMD Zena Max SARS-CoV-2 is compatible with the most common Real Time PCR equipment as Biorad CFX96, Applied Biosystems 7500 Fast, QuantStudio 3,5,7, StepOne Plus, Aglient Mx3000, 3005P, Rotorgene Q, Cepheid Smartcycler, Analytik Jena qTower and Roche Lightcycler 480, 96.
One Step Real-Time PCR Technology
Compatible with most common Real-Time PCR equipment
Intended Use
This assay is a Real-Time in vitro PCR test for the qualitative identification of the novelSevere Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2/COVID-19). It enables the direct amplification and identification of SARS-CoV-2 from human samples such asnasopharyngeal, nasal, oropharyngeal swabs. It is based on the hydrolysis probe detection method and is a highly sensitive one-step RT-qPCR kit. With the help of different coloredchannels producing signals, the sample can be positive or negative.
For in vitro diagnostic use.
Sample Type
human samples like nasopharyngeal swabs (NPS), nasal swabs, nasal wash or aspirate or bronchoalveolar lavage (BAL)
Target
ORF1 ab gene and N gene
Sensitivity
The Zena Max COVID-19 qPCR kit is highly sensitive, able to detect a minimum of 10 copies per reaction under our validation methods and devices.
Specificity
The analytical specificity study was carried out by in silico analysis shows that the AMD SARS-CoV-2 assays 100% sequence identity to 769 out of the 773 (99.4%) SARS-CoV-2 genomes available in the public databases, however, there is no cross-reactivity with any other coronavirus sequenced or the most common respiratory pathogens thus far.
Clinical Performance
The clinical performance of Zena Max SARS-CoV-2 Real Time PCR Detection kit was tested using clinical specimens in transport medium. 174 individual negative nasopharyngeal specimens and a total of 18 positive clinical samples tested with a validated molecular comparator assay.
Low positive contrived clinical samples were prepared by spiking a quantified clinical sample into individual negative clinical samples to approximately 30 samples.
All clinical samples were collected from patients with signs and symptoms of upper respiratory infection by qualified personnel according to the package insert of the collection device and stored frozen until use.
These results were compared with those obtained with a molecular detection method.
Result: 100% sensitivity
Instrument compatibility
AMD Zena Max SARS-CoV-2 is compatible with the most common Real Time PCR equipment as Biorad CFX96, Applied Biosystems 7500 Fast, QuantStudio 3,5,7, StepOne Plus, Aglient Mx3000, 3005P, Rotorgene Q, Cepheid Smartcycler, Analytik Jena qTower and Roche Lightcycler 480, 96.
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