On March 16, there have been 11 COVID-19 virus nucleic acid detection reagents and 8 antibody detection reagents approved by the Chinese Food and Drug Administration (CFDA). Among these companies that produce testing kits, 11 manufacturers have completed European Union CE certification in order to conduct their sales to more regions.
The escalated demand for testing kits worldwide can be addressed by China’s manufacturing capabilities. Chinese manufacturers possess a strong supply network that produces large quantities of testing kits, masks and other necessary equipment at fast rates and affordable costs. Through their trusted supply network and attentive control over the production process. Chinese manufacturers resolve the shortage of testing kits urgently needed in many parts of the world.
There are many large and small industrial manufacturers that are now involved in the business of distributing and crafting protective equipment to combat the threat of COVID-19. For this reason, the regulation of medical goods by the government and other agencies remains strict and encourages a consistent flow of medical resources worldwide. By the end of March, 26 countries made more than 15 million orders from China’s reliable testing kit manufacturers.
To ensure easy distribution of virus detection kits, KP connects you to manufacturers certified to distribute to your markets. We are willing to support countries in the fight against COVID-19 by directing you to qualified medical distributors with your required resources.
COVID-19 testing kits contain all the required reagents to diagnose any individuals for the disease as well as for instructions to individuals performing the tests. Polymerase chain reaction (PCR) testing is the most common method to detect COVID-19 among patients. However, PCR requires laboratory, specialists, and specific diagnostic tools. The procedure can also take around three hours to finish.
Because of the urgency presented by the COVID-19 pandemic, an efficient approach is needed to test many individuals within a short time. Nucleic acid COVID-19 test kits are being developed with improved qualities. The methods can also be batch tested in parallel of 100 to 200 tests at a time.
Fluorescence PCR Method
The product looks for a specific target gene of the Coronavirus. The kit can produce results within two to three hours.
Loop-mediated Isothermal Amplification- RT-PCR Method
Much like the Fluorescence PCR Method, the kit detects the Coronavirus’ target genes within an individual. The method does not require as many equipments as the previous kit and results can be generated within one to two hours.
Strand Displacement Assay
While this kit looks for the specific target gene of the Coronavirus among patients, the equipment required by this procedure is smaller than the previous PRC methods. Tests can also be completed within one hour.
Targeted RNA Sequencing Method
The kits are easier to utilize than other PCR testing methods in finding the specific gene of the Coronavirus. The procedure only takes one and a half hours to finish.
Six Respiratory Virus Nucleic Acid Detection Kits (Isothermal Amplification chip Method)
The virus test kit is designed to not only detect Coronavirus and its new strain, but it can also detect Influenza A virus, H1N1, Influenza virus, and much more. Results are generated within one and a half hours.
Antibody COVID-19 test kits also allow any staff to perform the diagnostic procedures minimum laboratory experience or equipment. Front liners can conduct patient screenings on remote areas such as border or checkpoint entry. Because of the fast and accurate detection, antibody test kits allow the government, medical, and any organizations to screen numerous patients.
Colloidal Gold Method
The method can provide a visual indication of early or previous infections without the need for any laboratory equipment by detecting IgM antibodies. Despite the low sensitivity, results can be generated within 2 to 10 minutes. The fast process makes the kit suitable for immediate large-scale testing.
Magnetic Particle Chemiluminescence Method
The method requires a chemiluminescence instrument to detect lgM and lgG antibodies within a patient. Despite the requirement, the COVID-19 testing kit has superior sensitivity, high specificity, optimum repeatability, and automation compatibility. Up to 200 batches of tests can be done at the same time and results are generated within 30 minutes.
Enzyme-Linked Immunosorbent Assay
The rapid Corona testing kit utilizes an enzyme-label instrument to run the tests. With the specialized equipment, the process of detecting lgM and lgG antibodies are easy, quick, and incredibly sensitive. 200 simultaneous batches can be conducted at the same time with the results generated within one hour.
The descriptions of both the nucleic acid and antibody virus test kits help you differentiate the various diagnostic methods available for the COVID-19 tests. You can get a better understanding of how the test kits work by reading further below.
The two virus testing kits mentioned consist of nucleic acid test and antibody detection. With the different methods available for the two types of test kits, these are the principles behind them.
Quantitative Fluorescence PCR Test kits that utilize this method incorporate real-time fluorescent PCR technology primers and probes to find specific genes of the COVID-19. The probe attaches to the template with the Taq enzyme decomposing it to create fluorescence. COVID-19 qualitative detection occurs with detected fluorescent signals to create a real-time amplification curve reading.
Isothermal Amplification Real-Time Fluorescence To detect the Coronavirus gene, the virus testing kit utilizes specific primers and DNA polymerase. The method also consists of constant temperature amplification with the reaction system. Real-time changes in the fluorescent signal provide the data for the test.
Combined Probe Anchor Polymer Sequencing The process utilizes the Joint Probe Anchor Polymerization, DNA Molecular anchors and fluorescent probes for genetic analysis and RNA detection. As the name suggests, the chemical structure of the reagents creates an intercalating anchor that attaches to the gene target and makes it fluorescent.
Colloidal Gold Virus testing kits that use this method incorporate immunochromatography technology to check on the serum, plasma, and blood cells of a patient for COVID-19 antibodies. These antibodies attach to the antigen label, creating a red reaction line.
Magnetic Particle Chemiluminescence Antigen of the COVID-19 virus is detected by measuring the light created by the reagents’ chemical reaction. This reaction comes from the conjugated antigen being sandwiched between the magnetic particle and substrate goes through incubation with an oxidant enzyme.
Given the dire situation around the globe, acquiring the right test kits is essential to screen many patients. The sensitivity of the tests is the first quality to consider since this will determine the efficiency of virus detection. The specificity of the detection procedures is also a relevant factor since this will provide an accurate reading on which patient has contracted the virus.
Tests with superior sensitivity and specificity ensure any organization to spot nearly 99% of individuals who are afflicted by the Coronavirus. The two qualities also lower the risk of false positives. You can find COVID-19 testing kits with the highest possible sensitivity and specificity on the KP platform. All testing products allow any organization to get the data needed to make crucial decisions and planning.
COVID-19 testing reagents from China play an important role in the detection and control of the virus worldwide. To ensure the quality of exported medical supplies, the Chinese Government implemented enhanced guidelines to get customs clearances. These guidelines indicate that foreign trade companies and manufacturers must provide proper documentation (including Medical Device Product Registration Certificate number and compliance certification) for the importing countries to prove they meet their quality standards. Additionally, compliance certifications must come from a certification body duly designated by the importing country.
KP Medical Supplies assists buyers by conducting compliance authentication and certificate validations with suppliers, making purchases quick and easy. Its pool of qualified medical supply manufacturers has proper and updated certifications for export in most countries, ensuring products pass international standards.
Foreign buyers are encouraged to validate these certificates prior to purchasing testing kits from suppliers in China. Below are the compliance requirements for testing regents by country as reference.
The new coronavirus detection reagents fall under the second category of in vitro diagnostic products per US classification. As such, an FDA certification from the US Food and Drug Administration is required before exporting the test kits to the country. The certification process includes:
– Premarket notification report or 510 (k) submitted to the FDA proving the safety and efficacy of the testing kit. The report should include the
• analysis items,
• specimen types,
• test types,
• product types,
• purpose of the results,
• performance test data, and
• product’s packaging label.
– Adherence to Quality Standard regulations (QSRs)
• Production quality management must follow ISO 9000 standards
• Medical laboratory management must have ISO/DIS 15189 standards
– The accomplishment of several forms, including
• FDA 2891 form for business registration
• FDA 2892 form for product registration
• 510 (k) application document at least 90 days before the product is marketed in the USA.
– In the case of Emergency Use Authorization, an application for EUA review 15 days before use.
The European Union dictates that all in vitro diagnostic products that are marketed for the EU must have the proper European certification (CE) mark. The new coronavirus detection reagents are classified under Appendix A, Class A of the IVDD. To complete the CE certification, trade companies must:
– Obtain quality assurance certification based on ISO 9000 and NE46000 standards.
– The manufacturer’s quality system, including design files and product types, should pass the evaluation of a testing agency.
– Register as a commercial agent in the EU.
Diagnostic reagents in Japan are under pharmaceutical products and are handled by the Ministry of Health, Labour, and Welfare with the supervision of the Pharmaceutical Machine Law. The management of IVD supplies and medical supplies fall under the same department, falling into one of two categories in registration:
Category 1: New testing items
Category 2: Existing testing items
Category 2 breaks down into 2 more parts:
2-A: More important items in health and health care
(1) In vitro diagnostic supplies for infectious disease detection.
(2) In vitro diagnostic drugs for blood type judgment.
(3) In vitro diagnostic supplies for pathogen genetic testing.
(4) In vitro diagnostic supplies for human genetic testing.
(5) Existing test items, but in-vitro diagnostic supplies using new measurement principles.
2-B: Items other than the above varieties
To pass customs clearance, a “Production and sales license of a pharmaceutical product” or a similar certificate must be attached to the entry copy, as well as a “copy of the approval certificate for the production and sale of pharmaceutical products” document for reference.
With the revisions made on the Korean Medical Devices Act in 2013, reagents used for in vitro diagnostics are classified as medical devices and must adhere to medical device regulations and standards. The KGMP certification classifies medical devices into four classes:
– Class I medical devices have relatively loose management process, and only require online registration at MFDS for certification
– Class II to IV medical devices need to pass a comprehensive review by the Korean medical device authority before allowed entry. Exported medical devices require a technical document that declares:
• ISO certification issues by 13485
• Product specification
• Product brochure
• Product raw material testing report
• Product packaging
• Shelf life verification report
• Software information (if applicable)
• Product performance test
• Clinical report (if applicable)
• Electrical safety and electromagnetic compatibility report (if applicable)
• Biocompatibility test (if applicable)
The Australian government implements a self-assessment format for low-risk enterprises while requiring government approval for high-risk enterprises. Under the jurisdiction of the Therapeutic Goods Administration, the Australian Register of Therapeutic Goods divides medical devices into three management types: Registrable, Listable, and Exempt. Only products approved after examination are eligible for selling, except for express exemptions. Also, Australia’s classifications of medical devices are similar to the EU classifications, meaning CE-approved medical devices are classified according to CE.
For export to Australia, coronavirus detection reagents must have
– Registration from the TGA of Australia
– Meets standard specification of AS/NZS 1716:2012, the standard respiratory protection is Australia and New Zealand
In many countries, there have been complaints about defective testing kits and faulty temperature guns. Consequently, regulators have shut down tens of thousands of shops distributing ineffective medical equipment. The Chinese State Administration for Market Regulation oversees standards for medical resources and testing. The government agency has punished thousands of companies and individuals involved in counterfeits and price gouging, among other serious offenses.
The COVID-19 epidemic has devastated the world with paralyzing fear and a growing death toll on the population. Responding to the surge of demands for virus detection kits, KP has created a medical platform consisting of qualified suppliers and experienced manufacturing companies. Our mission is to connect you to the right manufacturers of testing kits that meet international requirements. We recommend specialists that follow all of the certifications and registration requirements listed by regional markets.
KP-verified suppliers are responsible for ensuring that their test kits have been tested for their efficiency and accuracy in detecting the virus. Our network of manufacturers follows the terms of our partnership agreement to ensure that they deliver quality products within schedule. As such, we guarantee that the distribution of testing kits is conducted much faster in order to address the urgent need of your markets.
Our recommendations bring you more options for faster imports and effective dispute resolution. We provide a list of logistics companies that can help you bring your shipments on time. KP can also refer you to legal offices that resolve issues on sales to reduce any risks in your business.
Together with our network of manufacturers, KP helps you fight against the global threat of COVID-19. You can conduct your business in a transparent environment that is thoroughly regulated and sufficiently supplied with quality virus detection kits.