GenomeCoV19 Detection Kit

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.

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

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.

-25 to -15°C

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. This was established by testing serial dilutions of SARS-CoV-2 genomic RNA (source: ATCC-VR1986D) into nasopharyngeal clinical matrix, verified to be COVID-19 negative, at the following concentrations: 100 cp/µl, 50 cp/µl, 5 cp/µl, 4 cp/µl, 3 cp/µl, 2 cp/µl, 1 cp/µl and 0.5 cp/µl. RNA extraction was performed with the Qiagen QIAamp DSP Viral RNA Mini Kit and tests were run on the Bio-Rad CFX96 qPCR instrument. The LoD was determined to be 5 cp/reaction and results are shown in the table below.

Clinical Performance (Contrived Samples):

A contrived clinical study was conducted with a total of 30 negative and 30 contrived positive samples. Positive samples were prepared by spiking ATCC-VR1986D SARS-CoV-2 reference genome RNA into nasopharyngeal matrix mixed with lysis buffer from QIAamp DSP Viral RNA Mini Kit at 1X, 10X, and 100X LoD. Tests were run on the Bio-Rad CFX96 qPCR instrument and results showed 100% Positive Percent Agreement (30/30 positive results) and 100% Negative Percent Agreement (30/30 negative results).

Clinical Performance (Remnant Samples):

A blinded clinical study was conducted using a SARS-CoV-2 Validation Panel with 60 nasopharyngeal/oropharyngeal/nasal swab remnant clinical specimens. These 30 SARS-CoV-2 positive and 30 SARS-CoV-2 negative remnant specimens were verified using a FDA EUA-authorized COVID-19 detection kit. RNA extraction was performed with the Qiagen QIAamp DSP Viral RNA Mini Kit and tests were run on the Bio-Rad CFX96 qPCR instrument. GenomeCoV19 Detection Kit test 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 June 29th, 2020. Results showed the sequences had 100% homology to all SARS-CoV-2 isolates analyzed, with two exceptions of MT451113.1 and MT534319.1 (homology of 95.2% in both cases). 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:

Cross-reactivity studies using a panel of organisms were conducted by both in silico analysis and wet-testing of whole organisms or purified nucleic acids. The GenomeCoV19 Detection Kit primers and probes were first analyzed in silico against each of the organisms listed in the table below using BLASTn. No cross-reactivity with >80% homology was found for any of the primer and probe sets. Additionally, the bacteria, viruses and pooled human wash described in the table below were included for wet-testing. Concentrations of 106CFU/mL (for bacteria) and 105pfu/mL (for viruses) were used to purify the nucleic acids using the Qiagen QIAamp DSP Viral RNA Mini Kit. There was no cross-reactivity observed for any of the organisms tested using the GenomeCoV19 Detection Kit on Bio-Rad’s CFX96 qPCR instrument. Cross-reactivity was defined as Ct < 40.

*ND = Not Detected

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

Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests, or by similarly qualified non-U.S. laboratories. This product is not licensed for sale in Canada.