SARS-CoV-2 Rapid antibody test CLUNGENE Corona rapid test – 25 test pack
SARS-CoV-2 rapid antibody test for the qualitative and simultaneous detection of IgG and IgM antibodies against SARS-CoV-2 in whole blood, serum or plasma. The rapid test shows no cross-reactivity, offers high sensitivity and delivers quick test results.
Our SARS-CoV-2 antibody rapid tests are BfArM-listed and therefore reimbursable.
The rapid antibody test for COVID-19 offers a cheap and fast alternative to the PCR test. The CLUNGENE COVID-19 rapid antibody test from Hangzhou Clongene Biotec Co. impresses with its specificity of 98.89%. The antigen test offers results that are highly precise. The results here already after 10 – 15 minutes and the laboratory capacities are significantly relieved.
What is the CLUNGENE COVID-19 Rapid Antibody Test?
for the qualitative detection of IgG and IgM antibodies against the SARS-CoV-2 virus in whole blood, serum or plasma samples from people who are suspected of having a COVID-19 infection. The COVID-19 IgG / IgM Rapid Test Cassette is an aid in the diagnosis of
Patients with suspected SARS-CoV-2 infection in relation to the clinical presentation and the results of other laboratory tests. It is recommended to use it as a supplementary test indicator for suspected cases with a negative nucleic acid test of the novel coronavirus or in suspected cases in connection with a nucleic acid test. Antibody test results should not be used as the sole basis for diagnosing or ruling out SARS-CoV-2 infection or for providing information on the status of infection.
Negative results do not rule out SARS-CoV-2 infection, especially in people who have come into contact with known infected people or in areas with a high prevalence of active infections.
Follow-up testing with a molecular diagnosis should be considered to rule out infection in these individuals.
Positive results may be due to previous or current infection with non-SARS-CoV-2 coronavirus strains. The test is intended for use in clinical laboratories or by on-site healthcare professionals, not for home use. The test should not be used to screen donated blood.
The COVID-19 IgG / IgM rapid test cassette consists of: 1) a burgundy-colored conjugate cushion containing recombinant SARS-CoV-2 antigens conjugated with colloid gold (SARS-CoV-2 conjugates), 2) a nitrocellulose membrane strip that contains two test lines (IgG and IgM lines) and a control line (C line). The IgM line is precoated with the mouse anti-human IgM antibody, the IgG line is coated with the mouse anti-human IgG antibody. When a sufficient volume of the test sample is dispensed into the sample well of the test cassette, the sample will migrate over the cassette by capillary action. IgM antibodies against SARS-CoV-2, if present in the sample, bind to the SARS-CoV-2 conjugates. The immune complex is then captured by the reagent precoated onto the IgM band, forming a burgundy IgM line, indicating an anti-SARS-CoV-2 IgM positive test result.
IgG antibodies against SARS-CoV-2, if present in the sample, bind to the SARS-CoV-2 conjugates. The immune complex is then captured by the reagent applied to the IgG line, forming a burgundy IgG line, indicating an anti-SARS-CoV-2 IgG positive test result. The absence of T-lines (IgG and IgM) indicates a negative result.
To serve as a procedural control, a colored line will always appear in the control line area, indicating that the correct volume of sample has been added and that a membrane wick has occurred.
This test is carried out by taking a sample of whole blood (venipuncture blood and capillary finger prick blood) / serum / plasma samples (EDTA, heparin, citrate).
The result is then available within 15 minutes. Wait for colored lines to appear. Interpret the test results after 15 minutes, but no later than 20 minutes.
How does the CLUNGENE COVID-19 rapid antibody test convince?
An important feature that speaks for the CLUNGENE COVID-19 rapid antibody test is above all the high quality and the exclusion of cross-immunities such as:
Respiratory Syncytial Virus-B, Human Corona Virus (NL63), Human Coronavirus (229E), Human Coronavirus (0C43), Influenza A H1N1 WS / 33, Influenza A H1N1 PDM-09, Influenza B Taiwan / 2/62, Human Para- Influenza Virus Type 1, Human Para-Influenza Virus Type 2, Human Para-Influenza Virus Type 3, Human Para-Influenza Virus Type 4, Human Adenovirus Type 1, Human Adenovirus Type 3, Human Adenovirus Type 8, Human Adenovirus Type 18, Human Adenovirus Type 23, Human Adenovirus Type 7, Human Adenovirus Type 5, Human Adenovirus Type 11, Human Rhinovirus Type 1, Human Rhinovirus Type 14, Human Rhinovirus Type 42, MERS Coronavirus, Human Metapneumovirus and the Respiratory Syncytial Virus-A.
But above all, the high sensitivity of 87.01% and the specificity, which is even 98.89%, are convincing arguments for the rapid test.
The Federal Office for Medicinal Products and Medical Devices (BfArM) lists the CLUNGENE COVID-19 rapid antibody test Hangzhou Clongene Biotec Co.
We will send you a special offer for your order, adjusted for orders of 1,000 or more. Please send your request to: email@example.com
A packaging unit is equipped with 25 pieces and consists of one:
Operating instructions thinner solution and
25 test kits that are individually packaged and consist of a test cassette, a sterile pipette, alcohol swab and lancet.
Which legal regulations apply to the COVID-19 rapid antibody test?
Since the rapid test of the antigens is an in-vitro diagnostic device and therefore also a medical product, these legal regulations also apply to the sale, purchase and use of the test kits.
The purchase of Corona rapid tests is now also allowed for private individuals.
The Covid-19 rapid antibody test and frequently asked questions:
Is the rapid antibody test for antigens safe?
The rapid antibody test is one of the safest rapid tests, because the senility here is 87.01%. The specificity value is also convincing in terms of quality with 98.89%. Above all, however, the high level of cross-reactivity is particularly important, especially now that the cold season is approaching us with the general waves of colds. In particular, coronaviruses pathogenic to humans such as hCoV-229E, -HKU1, -NL63 or -OC43 or influenza viruses (such as influenza A / B) can be excluded.
How is the sample for the rapid antibody test obtained?
The smear required for the CLUGENE COVID-19 rapid antibody test is carried out by taking a sample of whole blood (venipuncture blood and capillary finger prick blood) / serum / plasma samples (EDTA, heparin, citrate).
Wait for colored lines to appear. Interpret the test results after 15 minutes, but no later than 20 minutes.
Which target group is suitable for the rapid antibody test?
All persons can be tested with the CLUGENE COVID-19 rapid antibody test. The test is particularly worthwhile for large facilities or events, as the laboratory capacities are not used and the result is available quickly.
The antibody rapid test – Corona rapid test contains all the necessary materials and can be used immediately regardless of location.
Is there a big difference to the PCR test procedure?
A PCR test is designed to detect the viral RNA. The rapid antibody test, on the other hand, detects a special component of the virus’s RNA, a protein that surrounds the corona virus, the nucleocapsid protein.
How expensive is the rapid antibody test for COVID-19?
The rapid antibody test impresses with its excellent price-performance ratio. A special advantage here, if you place an order for more than 1000 pieces, we will make you a personal, individual offer.
According to the new Corona regulation, which was updated on October 15, 2020, the Federal Ministry of Health will cover material costs for point-of-care tests up to a maximum of 7 euros for nursing facilities and medical practices.
How long do I have to wait for the rapid antibody test?
If you order the rapid antibody test, it can be delivered immediately, even in large quantities.
For business customers & B2B customers
We also deliver larger orders for schools, daycare centers, institutions, authorities and companies on account.
Payment on account.
Send us your request or order by e-mail to:
Inquiries and prices for larger orders from 1,000 pieces on account? Please contact our business customer service at firstname.lastname@example.org
or by phone +49 (0) 3562/98 76 087 or via our contact form: