Covid19 Rapid Test Cassette

*Instruction Manual Download

√ Significant time and cost-saving over lab methods
√ Results within 15 minutes
√ Easy to use
√ High Accuracy for the antibody of IgG/IgM

Description

COVID19 Rapid Test Cassette

COVID19-Rapid-Test-Cassette

Rapid-Test-Cassette

Our test is CE certified for Professional use. COVID19 rapid test check the body’s response to coronavirus after the onset of infection and gives a qualitative final result within 15 minutes.

Performing rapid test for COVID19 can save a lot of time and costs when compared to PCR nucleic test and will help to control the spread of the virus rapidly and accurately.

Easy to use, only need a finger-blood sample to perform, it is quite similar to perform a blood glucose test.

Covid19 Rapid test cassette can also be run with serum or plasma samples.


Package Information:

NameSizeWeightRemark
Aluminum foil bag120*65mm1 PCS
Box190*125*70mm220g25PCS
Package Case395*515*375mm10kg1000PCS/40Box
COVID19-Rapid-Test-Cassette-Aluminum-Foil-Bag

Aluminum-Foil-Bag

COVID19-Rapid-Test-Cassette-Color-Box

Color-Box

 

 

 

 

lancets

Lancets


FAQ’s

How does COVID19 Rapid Test Cassette work?

The test is a lateral flow immunoassay test and operates in a similar way to a pregnancy test. Embedded into the test strip are antibodies that bind to a COVID-19 specific biomarker, Immunoglobulin G (IgG), and another infection biomarker, Immunoglobulin M (IgM). When a sample (blood, serum, or plasma) is added to one end of the test, it flows along the test strip and interacts with these antibodies.

What are IgG and IgM?

Immunoglobulins are antibodies themselves and are part of our immune system. When we get an infection, such as COVID-19, immunoglobulins are produced, which attach to the virus and activate the rest of the immune system to attack and clear the virus. IgM is the first immunoglobulin to be produced and is a general antibody that can bind to many different types of pathogens. The presence of IgM is an indicator of early infection. IgG is a more specialized antibody that specifically binds to the SARS-CoV-2 virus. The presence of IgG is an indicator of later-stage infection (usually 7 days or longer after infection).

Is the test specific for COVID-19?

The IgG that the test detects is specific to COVID-19, so a positive result would indicate COVID-19 infection. Although the IgM is a more generalized antibody, its presence, combined with IgG and/or the common symptoms of COVID-19, would also indicate infection with the novel SARS-CoV-2 virus. The test can be used for primary and secondary diagnosis of COVID-19.

What samples can I use?

The test cassette will work with whole blood, plasma, or serum. Capillary blood is the easiest to obtain via a finger pinprick, however, venous blood obtained via venepuncture is also suitable. The type of sample will not affect the sensitivity or accuracy of the test.

What is the buffer solution for and can I use any buffer with the test?

The buffer solution has two functions. It acts as the carrier for the sample, allowing it to laterally flow along the test strip, and it maintains a constant sample pH as it flows, preventing degradation of the biomarkers and the antibodies. We recommend that you only use the buffer solution provided with the test kits, as other ones may affect the accuracy of the test.

So can the test detect asymptomatic patients?

Yes, the test will be able to detect IgM/IgG in asymptomatic people, as they will have an immune response even though they don’t display symptoms. The timeline of infection will be the same as someone displaying symptoms.

What is the shelf-life of the test cassette?

The shelf-life is 24 months from the date of manufacture. The product expiry is printed onto the packaging for reference. Do not use after the expiry date.

Will IgG and IgM remain in the blood after I’ve recovered from COVID-19?

There is some evidence that IgG/IgM remains in the blood after recovery to prevent reinfection. We have tested some patients and noticed that they still test positive for at least 33 days after first displaying symptoms. You won’t be infectious after you recover, even if you test positive, but you should still be cautious as long term immunity has not yet been confirmed and reinfection may still occur.

Can babies and young children be tested?

Yes, there are no issues with testing babies and young children.

Can pregnant or breastfeeding women be tested?

Yes, there is no harm to the mother or baby when performing a test.

Is there anyone that shouldn’t be tested?

No, the more people that are tested, the better it will be to understand the spread of the virus, which will result in better measures being taken to prevent its spread. However, as the test requires a blood sample, anyone with a blood-related health condition (such as hemophilia) should discuss this with a healthcare professional before performing a test.

Is the test CE marked? Does it have IVD certification?

Yes, the COVID-19 test is CE marked for professional use and is therefore a registered IVD device.

Has the test been accredited?

The COVID-19 test is CE marked for professional use and is therefore suitable and ready for use by a healthcare professional. In addition to our clinical evaluations already completed on the product, we are currently working with a number of independent laboratories and Departments of Health across Europe to further validate the product and gain best practice approvals.

Do you have a confirmation lab test for Coronavirus to confirm positive samples?

This screening test is designed to be used alongside a robust screening protocol with laboratory confirmations. We would recommend you work within your healthcare institution to ensure the correct protocols are being followed when using this product.

Additional information

Weight0.22 kg
Dimensions39.5 × 51.5 × 37.5 cm
Quality Standard

CE IVD, ISO13485

Result Time

15 Minutes

Shelf Life

24 Months

Samples Available

Available

Accuracy

Sensitivity > 91%, Specificity > 99%, Accuracy > 97%

You may also like…