GenomeCoV19 Detection Kit

CAT.NOUNITPRICE
G628100 Rxns
$0.00

Specifications


Description

The most affordable qPCR Detection Kit for SARS-CoV-2 on the market.

abm’s GenomeCoV19 Detection Kit is a real-time reverse transcription-polymerase chain reaction (RT-qPCR) test intended for the qualitative detection of RNA from SARS-CoV-2 in human nasopharyngeal and oropharyngeal swab specimens from individuals suspected of COVID-19 by their healthcare provider. Our GenomeCoV19 Detection Kit is the most affordable qPCR detection kit on the market at only $1.77 USD/test (limited time pricing for US customers only).

This kit is widely used in Europe under the CE-IVD certification and is listed by U.S. Food and Drug Administration (FDA) for distribution in the USA, under Section IV.C.

GenomeCoV19 Detection Kit Features

SKUG628
Applications

An ideal tool to detect COVID-19/ SARS-CoV-2 by RT-qPCR method

Product Features• Highly specific for the RdRP and N target markers recommended by WHO and US CDC
• Ready-to-use reaction kit that includes MasterMix, Primers/Probes, and Internal Positive Control
• Can be used with samples collected from naso/oropharyngeal swabs
• Results ready in less than 2 hours
• Compatible with standard RT-qPCR machines (Bio-Rad CFX96, Flex 7TM QuantStudio, Agilent's Mx3005P etc.)
Protocol OverviewTo help researchers in the global fight against the coronavirus, abm has developed an RT-qPCR Rapid Detection Kit for COVID-19 / SARS-CoV-2 that can be used on human respiratory tract specimens.

Target genes:
• RdRP and N genes as recommended by WHO and the US CDC

Advantages:
• Results in less than 2 hours
• Includes MasterMix, Primers/Probes, Internal Positive Control and Negative Extraction Control
• 100 Reactions/Kit

Kit components:
• Mastermix
• Primers/Probes
• Positive Control
• Negative Extraction Control

Specimen types:
• Naso/Oropharyngeal swabs
Note

This product is CE-IVD certified and listed on the U.S. Food and Drug Administration (FDA) website, under Section IV.C. For professional use only.

Storage Condition

-25 to -15°C

Unit quantity100 Rxns
QC

Limit of Detection (LoD):

Our LoD study established the lowest concentration of SARS-CoV-2 RNA, as genome copies (cp) per reaction, which can be detected by the GenomeCoV19 Detection Kit at least 95% of the time. Positive reference sample was tested using both positive control template (IDT, Cat 10006625) and in vitro transcribed RNA control (IVT-RNA) from in house. The initial LoD was determined by testing template at 5000, 500, 50 and 5 cp/reaction in quadruplicate. The final LoD was confirmed by testing additional 20 replicates of samples at 5 cp/reaction (20/20 positive results). At the LoD threshold, the Ct was observed to have a mean of 32.72 (SD 0.43, % CV 1.32). The LoD was determined to be 5 cp/reaction.

Clinical Performance (Contrived Samples):

A contrived clinical study was conducted to evaluate the clinical performance. A total of 60 individual nasopharyngeal clinical specimens, collected from volunteers and presumed negative for SARS-CoV-2, were used in this study. A total of 30 negative and 30 contrived positive samples were tested. Positive samples were prepared by spiking BEI ATCC Genomic RNA from SARS Related Coronavirus 2 (Catalog No. NR-52285) into NP matrix mixed with lysis buffer from QIAamp DSP Viral RNA Mini Kit at 1X, 10X, and 100X LoD. Results showed 100% Positive Percent Agreement (30/30 positive results) and 100% Negative Percent Agreement (30/30 negative results).

Inclusivity (Analytical Sensitivity):

The primers and probes sequences were blasted against SARS-CoV-2 genomes publicly available as of on March 20th, 2020. Results showed the sequences had 100% homology to all SARS-CoV-2 isolates analyzed, with two exceptions of MT159720.1 and MT258382.1 (homology of 94% and 95% respectively). Both exceptions occur at the 5'end of the primer, and thus are unlikely to cause the failure of qPCR, and would not affect the test performance under specified annealing temperature.

Cross-Reactivity:

The detection results of this kit displayed no cross-reactivity with influenza A virus, influenza B virus, adenovirus, Staphylococcus epidermis, HCoV-SARS, HCoV-OC43, HCoV-HKU1, or Streptococcus pneumonia.

Precision: CV < 5% (Between and within batches).

DisclaimerFor in vitro diagnostic use only. For professional use only. This product is not licensed for sale in Canada.
FAQs


There are no FAQs for this product yet!
References


There are no references for this product yet!