As effects of the SARS-CoV-2 pandemic ramp up worldwide, the FDA has issued an emergency call for organizations to develop products to combat the resulting disease COVID-19. At EpiGentek, we have leveraged our resources and competencies including production and supply chain capabilities to bring much needed COVID-19/SARS-CoV-2 testing kits into the hands of healthcare workers. Testing kits are part of a critical toolset in controlling and ultimately defeating COVID-19. We are proud to introduce our first test, a rapid serological kit that identifies for SARS-CoV-2 antibodies in blood samples, that can be easily used to by frontline healthcare professionals.

The main advantage of testing for antibodies is that one can gauge both current and past COVID-19 infections due to the fact that antibodies are longer lasting indicators compared to viral RNA in the respiratory tract. An indication of past infection in particular can potentially show when patients have built up natural immunity and give a timeframe as to when those previously affected can return to school or the workforce to help anchor the economy in this time of crisis. Research is ongoing on the nature of SARS-CoV-2 and the effectiveness of our antibodies in relation to stopping the spread of the virus, but serological antibody-based tests offer a promising advantage that can have greater implications in the worldwide effort of curbing this pandemic.

This listed device has been assigned a Pre-EUA number and is currently undergoing FDA review for EUA approval.

This low-cost method identifies the presence of IgG and IgM antibodies of SARS-CoV-2 from plasma, serum, or whole blood as well as fingertip blood samples. The simplicity and speed of the procedure not only reduce backlogging of testing by laboratories, but the rapidness without need of special instruments makes it an ideal tool at point-of-care by healthcare workers. This kit uses colloidal gold immune technology by spraying colloidal gold-labeled recombinant SARS-CoV-2 antigen and a control antibody gold marker on the binding pad, which is then contained in a test card consisting of a plastic card vessel and a strip of testing paper for convenient use.

A clinical study with 128 blood samples from 103 confirmed COVID-19 patients and 25 healthy individuals showed that, in blood samples, the integrated IgG/IgM test can detect at a 97.78% accuracy rate for patients with an infection window of 11-24 days, and an 84.48% accuracy rate for patients with an infection window of 4-10 days. The total accuracy of positive and negative correlation for an infection window of 4-24 days is 92.19%.

• Rapid Method: Obtain results within 3-15 minutes without special instrumentation.
• Zero Sample Prep: Detection directly from plasma, serum, or whole blood, as well as fingertip blood samples.
• Two-in-One: Both IgG and IgM antibodies are simultaneously detected for additional confirmation, saving on costs versus other methods that detect them separately.
• High Sensitivity: 97.8% positive test correlation for IgM antibodies in patients with an infection window of 11-24 days; Total approximate accuracy of both positive and negative correlation with IgG and IgM signals is 92%.
• High Specificity: 100% negative correlation without cross-reactivity to other human coronaviruses, influenza A/B viruses, and many other viruses.
• Early Detection Window of IgM: Antibodies can be detected in as early as four days while symptomatic.

• Fast: The entire procedure can be completed in less than 45 min.
• High Sensitivity: Detection limit (LoD) can be as low as 0.002 µg/ml SARS-CoV-2 IgG antibody.
• High Specificity: Specific for SARS-CoV-2 IgG and IgM, with no cross-reactivity to many other viruses.
• Precision: Inter-assay ≤ 8%; Intra assay: ≤ 12%.
• Flexible: Strip-well microplate format makes the assay available for manual or high throughput analysis and allows for the detection of IgG or IgM alone or both IgG and IgM at the same time.

Measure viral RNA with a complete set of optimized buffers and reagents suitable for quick preparation of viral RNA from cell-free liquid specimens, specifically from saliva and nasal or nasopharyngeal swabs. The specialized buffering system allows RNA to bind to the glass fiber matrix of the spin column, or to magnetic beads while impurities are efficiently washed away, and pure RNA is eluted.

Total RNA isolated from nasal swab samples with EpiQuik™ Viral RNA Isolation Fast Kit and was used for RT-PCR analysis. A: Nasopharyngeal swab samples were spiked with SARS-CoV-2-N positive control; B: Nasopharyngeal swab samples were not spiked with SARS-CoV-2-N positive control. PCR was processed with use of primers and probes against SARS-CoV-2 N1/N2 and human RNase P gene (internal control).

• Fast procedure delivers high-quality total RNA in total 10 minutes.
• Ready-to-use RNA for high performance in downstream applications.
• Consistent RNA yield from a small amount of starting material.

• Fast procedure delivers high-quality total RNA in 25 minutes.
• Allows small size (>30 bases) and large size (<200 kb) samples to be isolated.
• Convenient handling without the need for centrifugation.

• High throughput and fast procedure allow delivery of total RNA from 96 samples simultaneously within 30 minutes.
• Allows small size (>200 bases) and large size (<200 kb) to be isolated.
• No centrifuging needed, and suitable for robot handling or automation setups

Laboratory diagnostic testing facilities and clinical labs should contact us as soon as possible using the contact form below as there are limited reagents and manufacturing capacity at this time. To help support the fight against the pandemic, we will be offering significant discounts on testing kits to qualified labs.

If you are a lab capable of conducting diagnostic in vitro testing or you can recommend any labs in need, please contact us immediately:

* Per FDA guidelines, please note the following disclaimer regarding serological-based tests:

• This test has not been reviewed by the FDA.
• Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals.
• Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.
• Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.
• Not for the screening of donated blood.