AMPER DiagONE COVID testing kit CE/FDA BASG BAG BfArM certification MADE IN USA
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FAQ
1. Can sample be sent free?
For quality reference, we can supply samples for free. But the freight will be collected.
2. Can I have my own brand?
Yes, OEM is acceptable.
3. Can you meet the regulation requirement of EU market?
Yes, all of our products are of EU regulation compliant.
4. Which market you exported before?
We have exported to countries of European countries, South America, Africa, Middle east.
7. Do you have a complete QC management systems?
Yes, we have IQC (Incoming Quality Control), PQC (Producing Quality Control), LQC (Line Quality Control) and FQC (Final Quality Control).
Background
The ongoing COVID-19 pandemic has made children below 18 years highly susceptible candidates with limited to no vaccination opportunities available for them. The routine screening of the children in school is challenging due to delayed reporting of results, high costs of RT-PCR tests, and access disparities among marginalized populations. Meanwhile, rapid antigen tests have garnered attention as they provide result in minutes, are low cost, and can diagnose infectious diseases easily. However, the efficacy of these kits among children is conflicting.
About the study
In the present study, the researchers evaluated the sensitivity, specificity, and positive predictive values (PPV) and negative predictive values (NPV) of the Abbott BinaxNOW rapid antigen test against the RT-PCR test in pediatric participants below 18 years in the US with high COVID-19 testing from May 7, 2021, to December 6, 2021.
The demographic details, symptoms, and perceived exposure status of the participants were noted before sample collection. The active COVID-19 symptoms were classified based on the standard Centers for Disease Control and Prevention (CDC) symptom checklist and the participants who had at least one symptom from the checklist were referred to as “symptomatic” while those with no symptoms were referred to as “asymptomatic”. Participants who have lived with or were within 6 feet of any suspected or confirmed COVID-19 patient for more than 15 minutes were considered to have high-risk exposure.
Findings
A total of 1054 children participated in the study among which 508 (48.3%) were female and 546 (51.7%) were male. The average age of the study participants was 8.9 years. Among the participants 438 (41.6%) were White, 105 (9.9%) were Hispanic and 373 (35.4%) were African American. The symptomatic status of 1046 (99.2%) participants was obtained among which 756 (72.4%) were asymptomatic and 290 (27.6%) were symptomatic.
Based on RT-PCR test results, the overall COVID-19 prevalence rate was 5.2% (55/1054) - 9.0% for symptomatic participants and 3.6% (27/756) for asymptomatic participants. Among the symptomatic participants, 96.2% (275/286) were tested within 7 days after symptom onset. The prevalence rate for high-risk exposure participants who were symptomatic and asymptomatic was 20% and 7.2%, respectively.
The sensitivity of the BinaxNOW rapid antigen test was 92.7% for all participants. The sensitivity was the same for symptomatic and asymptomatic participants including those with high risk for exposure.
The specificity of the rapid antigen test for all participants was 98.0%, and the specificity for symptomatic and asymptomatic participants was 96.6% and 98.6%, respectively. For the symptomatic participants, the PPV was 72.7% and the NPV was 99.2%; For the asymptomatic participants, the PPV was 71.4% and NPV was 99.7%.
The average cycle threshold (CT) was similar for the symptomatic and asymptomatic groups (28.6 vs 27). At the CT count of 30 or below, the test showed 100% sensitivity for both symptomatic and asymptomatic participants.
Limitations and conclusion
The present study had some limitations including the following: a) the study enrolled only a few children with high-risk exposure, b) the study was single centered and the testing from a single-site cannot be generalized to all situations, and c) out of four false-negative tests, three were collected within 3 days of high-risk exposure which may be too early for detection by a rapid antigen test.
Overall, the present study confirmed the high accuracy of rapid antigen test kits and demonstrated rapid antigen tests as a reliable means to diagnose COVID-19 in children; therefore, the authors recommend they should be made widely available in schools to screen for COVID-19 in children.
*Important notice
medRxiv publishes preliminary scientific reports that are not peer-reviewed and, therefore, should not be regarded as conclusive, guide clinical practice/health-related behavior, or treated as established information.
As the number of Covid-19 cases increases, so does the need to test more people.
The reason for this is that accurate and reliable testing has proven to be an effective way to slow the spread of the coronavirus to save lives and reduce the burden on healthcare systems.
There are two types of Covid-19 tests — polymerase chain reaction (PCR) test and rapid antigen — recommended by government to test for the virus.
What is the differenc?
According to government, PCR tests are regarded as the “gold standard” for Covid-19 testing.
A sample is taken from the nose or throat and sent to a lab where it undergoes a process to check if the virus is present.
PCR tests are recommended for diagnosing active Covid-19 infection. Results are normally available within a day.
“A PCR test is a molecular method that detects genetic material from the virus and is very accurate, but results take about 24 hours,” said government.
Antigen tests are cheaper, give a result in about 15 minutes but are less accurate.
A rapid antigen test works by looking for proteins on the surface of the virus. As with PCR tests, samples are usually taken from the nose or throat but can be tested on site.
The World Health Organisation said antigen tests typically have high specificity, which means the chance of false positives is low, but they are significantly less sensitive than PCR tests.
Which test is likely to pick up Omicron?
According to the National Institute of Communicable Diseases indications are PCR tests can detect the Omicron variant of the virus.
The tests, the costs of which have been reduced from R850 to R500, are used to determine if there is specific genetic material from the coronavirus present.
“A PCR test is a nucleic acid-based test, RNA in the case of Covid-19. The test uses a set of enzymes technologies to accurately detect Covid-19 specific genetic markers,” the Council for Scientific and Industrial Research told TimesLIVE.
The institute said the tests check for multiple targets in case there is a variant present.
“The PCR tests typically detect at least two different SARS-CoV-2 targets, which serve as a backup in the case of a mutation arising in one.
“Analysis of the mutations in the nucleocapsid (N gene) of B.1.1.529 viruses suggests rapid antigen tests should be unaffected. However, verification of this is under way,” it said.
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