The COVID-19 pandemic has changed the way we interact as individuals and changed the face of medicine and diagnostics - possibly forever.
The demand for fast-turnaround molecular testing has grown exponentially as has the need for result accuracy. Faster and more accurate testing, along with a vaccine, are the paths that lead the world back to work, education and to socialise as we did pre-pandemic.
EKF Diagnostics is working with some of the world's leading epidemiology organisations to manufacture and distribute tests and kits that will ensure communities can get back to normal as quickly and as safely as possible.
COVID-SeroKlir is a quantitative SARS-CoV-2 IgG antibody test kit with FDA clearance and is CE marked. COVID-SeroKlir is a two-step ELISA kit which determines the presence and precise level of IgG antibodies from a blood sample and has a broad range of applications including the assessment of vaccine response.
COVID-SeroKlir has demonstrated 98.8% sensitivity and 99.6% specificity for detecting SARS-CoV-2 specific IgG antibodies against two virus antigens - the full-length spike protein and its receptor-binding domain.
The test is based on technology developed by Mount Sinai Hospital Group in New York City during the height of the COVID-19 outbreak. The test is manufactured by Kantaro and uses Bio-Technie's gold-standard ELISA platform. It received its FDA EUA in November 2020.
The growth in the demand for molecular testing has seen a corresponding surge in demand for sample transport media - usually referred to as Universal Transport Media (UTM) or Viral Transport Media (VTM).
Standard UTM and VTM media were designed for transporting intact viable microbial samples for culture. This means that the sample carries a biohazard risk which requires a controlled environment for subsequent laboratory work. Additionally, because the samples are live, cold chain storage and transportation is imperative.
UTM and VTM may also contain enzymes and nucleases that can cause damage to RNA and DNA. If the sample is damaged it will inhibit the quality of the result that can be obtained through PCR testing.
However, modern molecular tests do not require a sample containing a live virus. Instead they require only intact microbial nucleic acids. PrimeStore MTM is ideal in this scenario as it neutralises the virus, maintains the RNA and DNA and, significantly, does not require refrigeration.
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