GenuIN® CoV2 Antigen Detection ELISA Kit #VKN2

The GenuIN® CoV2 Antigen Detection ELISA kit is a chemiluminescent enzyme-linked immunosorbent assay intended for the qualitative detection of nucleocapsid antigen from SARS-CoV-2. The GenuIN® CoV2 Antigen Detection ELISA Kit is intended for research use only.

The GenuIN® CoV2 Antigen Detection ELISA Kit is to be used with the Stellux® 4400 Chemiluminescence Plate Reader. The following commonly used laboratory instruments are also needed: magnetic stand, rotating test tube mixer, microplate orbital shaker, and so on.

The GenuIN® CoV2 Antigen Detection ELISA Kit is an indirect enzyme-linked immunosorbent assay test. In principle, a portion of the specimen is coated to a microplate well. The well is then washed, blocked, and incubated with primary antibody against SARS-CoV-2 nucleocapsid protein. After a brief wash, a horseradish peroxidase (HRP)-conjugated secondary antibody is applied. Finally, a proprietary HRP substrate is added to the well to generate chemiluminescent light, which can be detected and reported by a chemiluminescence plate reader.

The limit of detection (LoD) studies determine the lowest detectable concentration of SARS-CoV-2 at which approximately 95% of all (true positive) replicates test positive. LoD of the GenuIN® CoV2 Antigen Detection ELISA kit was determined by limiting dilution studies using characterized gamma-irradiated SARS-CoV-2 spiked in pooled negative SP swabs in saline. For LoD screening, 10-fold serial dilutions of the gamma-irradiated SARS-CoV-2 stock in pooled negative NP swab specimen in saline were made. The diluted SARS-CoV-2 were tested in triplicate for ΔRLU. The lowest concentration at which 3 out of 3 were positive was 1/1000 (280 TCID50/mL) dilution of the original stock. To find the LoD range, we further diluted the SARS-CoV-2 stock in pooled NP swab specimens in saline at 1/1,000, 1/2,000, 1/3,000, all the way down to 1/10,000, and tested the diluted samples in triplicate. The lowest concentration at which all three triplicates were positive was chosen as the LoD. Based on this study, the LoD of our test device is 56 TCID50/mL.

A clinical evaluation study was performed to evaluate the performance of the GenuIN® CoV2 Antigen Detection ELISA kit using NP swab specimens in saline.

A total of 150 specimens were purchased from a commercial vendor.

• 60 positive nasopharyngeal (NP) swab specimens in saline
• 90 negative nasopharyngeal (NP) swab specimens in saline

These specimens were originally collected in saline and confirmed positive or negative by EUA RT-PCR tests. These specimens were transported in dry ice and frozen in -80°C before analysis.

These 150 specimens were randomly assigned to 4 microplates and processed and tested by one operator all on the same day. The following table summarizes the performance of the kit.

Based on the clinical trial data, the positive percent agreement (PPA), negative percent agreement (NPA), and overall percent agreement (OPA) with their respective 95% confidence intervals (CIs) were calculated:

PPA: 92% (CI: 82%-97%)

NPA: 100% (CI: 96%-100%)

OPA: 97% (CI: 92%-99%)

• Reay-to-use kit including required components
• Detailed instructions are simple to understand and follow
• Suitable for detecting SARS-CoV-2 in human nasopharyngeal swabs in saline solution

GenuIN® CoV2 Antigen Detection ELISA Kit #VKN2