COVID-19 diagnostic kits: A game-changer for the disease transmission in China?
COVID-19 has significantly affected Chinese citizens and spread overseas. Due to its epidemic characteristics, accurate and sufficient diagnosis plays an important role in controlling disease transmission and progression. It can also significantly affect the patient pathway, especially in Wuhan. The virus causing COVID-19, SARS-CoV-2, was first sequenced on January 10th 2020. One week later, on January 16th, Chinese researchers and biotech companies were able to send diagnostic kits to the most affected areas. Within the last month, I have witnessed the emergence of several innovative COVID-19 diagnostic kits that may change the disease picture enormously. In this article, I will guide you through the development status of these diagnostic kits, their advantages and the potential challenges they are facing.
Nucleotide detection kit for COVID-19: uncertain reliability?
The first groups of COVID-19 diagnostic kits are nucleotide detection-based kits using real-time RT-PCR. The mechanism behind it is the detection of specific nuclear acid sequences for the SARS-CoV-2 virus. The first three diagnostic kit producers which were allowed by the Chinese National Health Commission are Shanghai Huirui Biotechnology, Shanghai Geneodx Biotech (a spin-off of SINOPHARM) and Shanghai BioGerm. As of February 10th, seven nucleotide diagnostic kit producers received approval for their product to be used for COVID-19 diagnosis.
When used in the most infected areas, the nucleotide kits started to show some false-negative cases which caused concerns in society. According to experts, there are several possible explanations for these false-negative results:
1. The main hypothesis is that the virus is being collected from patients below the detection threshold. During coughing, SARS-CoV-2 virus situated in the lungs is brought to the throat region. However, for some patients, samples collected from the throat may not be sufficient for virus detection.
2. Secondly, due to the low stability of the SARS-CoV-2 RNA, any inappropriate manipulation can cause sample degradation.
3. Last but not least, a not optimized diagnostic reagent design (primers in this case) or the poor quality of the kit itself can raise the number of false-negative results.
Therefore, the large gap between the performance of the diagnostic tests available and the growing diagnostic needs were identified as the top challenges for Wuhan right now.
New COVID-19 diagnostic kits developments: a game-changer?
In order to fill this gap, Chinese academic researchers and biotechnology companies have been closely collaborating to improve diagnostic kits. Ready-to-use room-temperature fluorescent amplification diagnostic kits and IgM immune antibody kits are the most recent developments.
The room-temperature fluorescent amplification kit can potentially solve sample stability issues during laboratory processing, and save time. Running this test takes only 20 minutes compared to the 3 hours requiredfor a fluorescent RT-PCR kit.
The IgM immune antibody kit uses a colloidal gold immunochromatography mechanism. The design of the kit aims at increasing testing specification and speeding up the testing time to 15 min. It is also more convenient to use for non-medical professionals.
These new types of diagnostic kits were sent for trials and may gain approval by the Chinese National Health Commission very soon. It is reasonable to assume that these easy-to-use fast diagnostic kits can largely relieve the accumulated pressure on nucleotide diagnosis and decrease potential infection rates by simplifying and speeding up the admission of patients to hospitals.
Overall, the whole medical community has dedicated many resources to the development of fast, specific and easy-to-use diagnostic tools for controlling COVID-19. A sufficient diagnostic is one of the key factors to control the spread of an epidemic disease. The earlier patients can be diagnosed, the lower the transmission of the disease will be. This is, of course, a challenge but also an opportunity for pharmaceutical and medical device companies to implement new technologies into further product development, with the aim of achieving faster, easier and more specific diagnosis readout. Our Alcimed GmbH team will continue to follow and decipher COVID 19 progression and treatment development. Stay tuned!
About the author
Bin, Consultant, Alcimed Healthcare Cologne Office
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