Fast Test Kit.Com: Antibody Test Kit for COVID-19 JOYSBIO, has developed and launched a point-of-care lateral flow rapid test cassette for the detection of 2019 novel coronavirus disease. The COVID-19 Antibody Rapid Test Kit is used to determine the IgG and IgM antibodies in human serum, plasma, and fingertip blood in vitro (Colloidal Gold). This product can be used for testing in the laboratory or at the point of care by clinical labs or Healthcare practitioners.
The COVID-19 lateral flow test detects SARS-CoV-2 antibodies quickly and effectively. Learn more about the new COVID-19 fast antigen test kit, which may be used to detect active infection quickly.
Features
- After a rapid start, detection took only 15 minutes.
- This technique is suitable for all blood types except fingertip and whole blood.
- IgG and IgM antibodies must be detected in a clinically useful way.
- A visual depiction of the outcomes collected at the point of care that is simple to grasp.
Production Environment and Capacity
JOYSBIO got ISO9001, ISO13485 QMS, and CE 0197 certification from TÜV Rheinland LGA Products GmbH as a consequence of following the China Food and Drug Administration’s quality management system. JOYSBIO is already producing over half a million test cassettes per day for distribution to healthcare workers throughout the world during this outbreak.
Performance characteristics
A clinical trial with 400 clinical samples from individual patients was used to validate the COVID-19 IgG/IgM Test Kit: 367 serum samples and 33 plasma samples (EDTA, heparin, and citrate). The study will take place at China’s provincial hospitals from January to April 2020. All research sites looked at 182 patients who had positive Real-Time RT-PCR results and 218 patients who had negative Real-Time RT-PCR results from the COVID-19 trial. The evaluation findings are summarised in the tables below. The sensitivity and specificity of the JOYSBIO COVID-19 antibody test kit meet diagnostic standards.
- Sensitivity, Positive Percentage Agreement, and Overall Positive Percentage Agreement = 170/182. (93.41 percent )
- Overall, there was a negative agreement of 209/218 percent (specificity, NPA) (95.87 percent )
- IgM sensitivity is 83.52 percent, while IgM specificity is 214/218 percent (98.17 percent )
- IgG sensitivity: 166/182 (91.21%); specificity: 213/218 (97.71 percent )
LATERAL FLOW TEST PRINCIPLES
The COVID-19 IgG IgM Antibody Test Kit (Colloidal Gold) from JOYSBIO detects both immunoglobulin G and immunoglobulin M antibodies of the 2019 novel coronavirus with just one test cassette. When a sample is placed in a test strip’s loading well, the blood filter film filters the sample. The COVID-19 IgM antibody can create a compound with colloidal gold-labeled novel coronavirus antigen if it is present in the test sample.
Using the mouse anti-human IgM antibody coated on the test cassette, the complex may be collected and a red color band formed (M line). If the test sample includes the SARS-CoV-2 IgG antibody, which interacts with the colloidal gold-labeled novel coronavirus antigen, a distinct type of complex forms. An antibody coated on the G line of the test cassette can be used to capture the complex after it has passed by capillary force to the other end of the cassette. For process assurance, the test kit includes a quality control line (Cline).
COVID-19 RAPID ANTIBODY TEST
Bring the COVID-19 Antibody Rapid Test Kit and the samples to room temperature. Tear the foil wrapping apart to remove the test cassette. Place the test cassette on a clean, flat surface. Fill the sample well with 10 microliters of serum or 20 microliters of whole blood (or plasma). Add 70 L (or two drops) of diluent to the sample well. The timer has begun to run. For 15 to 20 minutes, room temperature results can be observed.
RESULTS OF TESTS ANALYSIS
The result of the COVID-19 Antibody Rapid Test Kit should be ready in 15–20 minutes after adding the sample and diluent to the sample loading well. After 20 minutes, invalid results are displayed. Colorful bands can be seen on both the M and C lines of the reading window in patients who have IgM antibodies to SARS-CoV-2. In the reading window, colored bands appeared on the G and C lines, indicating that the patient had IgG antibodies against SARS-CoV-2. Colored bands appeared only on the Cline in the reading window, suggesting that the patient has neither IgM nor IgG antibodies to SARS-CoV-2, as evidenced by the data. There is no colored band on the Cline in the reading window at that place, indicating that the value is invalid.
Biolidics A new COVID-19 ten-minute Rapid Test Kit
Singapore’s Health Sciences Authority (HSA) has given the Medtech company a preliminary license to use its quick test kit in the country. Biolidics, a Singapore-listed medical technology firm, has introduced a quick test kit for COVID-19, and the two parties have agreed to collaborate on the development and production of the rapid test kits. Biolidics expects to provide the first batch of rapid test kits in April 2020. Biolidics has received preliminary authorization from the Singapore Health Science Authority (HSA) to use its rapid test kit in Singapore. Clearbridge Health is working with a cancer diagnostics company to get the required clearances and authorization from health authorities in the region to utilize the rapid test kit.
BECAUSE IT IS IMPORTANT
Patients with COVID19 are now verified using polymerase chain reaction (“PCR”) testing, which is a laboratory procedure that requires the use of laboratory personnel and specialized medical testing equipment and takes three hours or longer on average. With these samples, Biolidics’ rapid test kit can detect COVID-19 with higher than 95% accuracy in serum, plasma, or whole blood in less than 10 minutes. Thanks to the quick test kit, decentralized screening of suspected patients can be more effective and efficient. It may be used to screen people at border crossing points or to look for COVID-19 infection clusters, for example.
IMAGINE A MORE COMPREHENSIVE IDEA
COVID-19 test kits developed in Singapore include a VereCoV detection kit from Veredus Laboratories, Fortitude Kit 2.0 from A*STAR and TTSH, and the ongoing development of a COVID-19 detection kit by health tech researchers. According to MobiHealthNews, the Singapore government also produced and deployed TraceTogether, a contact tracing program, earlier this month. As of 12 p.m. on March 30, 2020, Singapore has 879 confirmed cases of COVID-19 and three fatalities related to it, according to the Ministry of Health. (MOH). The Ministry of Health has placed over 13,000 people under quarantine. 4,737 are currently being quarantined, while 8,247 have completely completed the process.
THE STORY BEHIND THE SCENES
COVID19 testing is critical as the pandemic expands over the world.” The fast test kit from Biolidics allows us to do point-of-care testing on a larger number of clusters, resulting in a more effective and efficient decentralized screening of suspected cases. “It can guide treatment decisions and significantly reinforce public safety measures,” said Dr. Leong Man Chun, Interim CEO of Biolidics, in a statement.
Clinic-based performance:
To assess the clinical performance of this product, clinical diagnostic criteria for new coronavirus pneumonia are compared to in vitro diagnostic reagents used in the test. A total of 1,585 cases of suspected new coronavirus infection were included in the study, with 421 cases confirmed and 1,164 cases removed. A study examined in vitro diagnostic reagents and clinical diagnostic criteria for new coronavirus pneumonia. According to test results, the product has a clinical sensitivity accuracy of 98 percent and a clinical specificity accuracy of 81 percent, respectively (95 percent confidence interval: 97 percent to 99.6 percent ).
(95 percent confidence interval: 97.05 percent, 98.74 percent) 203 individuals were given homologous serum/plasma and whole blood specimens for comparative testing (125 of which were positive and 78 of which were negative). According to the findings of this study, serum/plasma test results have a consistency rate of 96.85 percent, and whole blood test results have a consistency rate of 96.85 percent (95 percent CI: 95.87 percent to 97.60 percent ). Early studies have mainly confirmed the clinical performance of the COVID-19 Rapid Test Kit IgG + IgM (Colloidal Gold).
