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Price
1 267,09 EUR excl. VAT (1 533,18 EUR incl. VAT)
2,53 EUR excl. VAT/pcs

Manufacturer
Textil pro firmy

Weight
1.95 kg

Package
500 pcs

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High-quality antigen tests from saliva. Rapid test for a new coronavirus antigen (SARS-CoV-2). Min. quantity 50pcs. Quantity discounts. More

Saliva antigen tests

The saliva antigen test is a rapid test for a new coronavirus antigen (SARS-CoV-2). The saliva test is an in vitro diagnostic test for the qualitative detection of SARS-CoV-2 coronavirus antigens present in human saliva using a rapid immunochromatographic method. Identification is based on the detection of monoclonal antibodies specific for the novel coronavirus antigen.

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Features:
Brand Realy Tech
Type Saliva
Packed in 5 pieces
Sensitivity: 93.94%
Specificity: > 99%
CE approval
Instructions for use can be found in the Files tab.
Registered type subject to exemption by the Ministry of Health. According to the MIT, you do not have to buy tests only from registered companies, but you can use approved tests (brand, type, manufacturer) of the Ministry of Health. 


Sale only to entities with valid ID number.
Minimum purchase is according to the selected variant.
Price is for 1 piece.



Intended use:
The SARS-CoV-2 N/S Antigen One-Step Test Device is a lateral flow based one-step immunoassay for the qualitative detection of a novel N/S coronavirus antigen in saliva samples. This product is designed to provide visual, qualitative results and is intended for professional use.

This test provides only a preliminary analytical test result. A more accurate alternative method must be used to obtain a confirmed analytical result. The preferred confirmatory method is the nucleic acid amplification assay. The new coronaviruses belong to the genus β. COVID-19 is an acute infectious disease of the respiratory tract. Humans are generally susceptible.

Currently, patients infected with novel coronaviruses are the main source of infection; asymptomatic infected people may also be a source of infection. According to current epidemiological research, the incubation period is 1 to 14 days, usually 3 to 7 days. The main manifestations include fever, fatigue and dry cough. In some cases, nasal congestion, rhinorrhea, sore throat, muscle pain and diarrhea occur.


Detection principles:
The one-step SARS-CoV-2 N/S antigen test device is a rapid chromatographic immunoassay based on the principle of sandwich antibody-antigen binding. This product is pre-coated with nanocarbon antigen monoclonal antibodies to anti-SARS-CoV-2 N and S, and the control line is goat anti-mouse IgG antibody.

During testing, the SARS-CoV-2 N/S antigen, if antigens are present in the saliva sample, will bind to the antibody conjugates to form a complex. And migrates upward through the capillary. The complex will then be captured by the immobilized antibody coated in the detection region on the NC membrane. A visible black line will appear in the detection region.

A black line will not form in the detection region of the test if the SARS-CoV-2 antigen is not present in the sample. A saliva sample positive for SARS-CoV-2 antigen will generate a coloured line in the detection area of the test due to antigen binding, whereas a saliva sample negative for SARS-CoV-2 antigen or containing a very low concentration of SARS-CoV-2 antigen will not generate a coloured line in the detection area of the test. A coloured line will always appear in the control line area (line C) as a process control, indicating that the correct volume of sample has been added and membrane leakage has occurred.


The name of the component:
Combination test card for SARSCov-2 antigen (2019-nCoV) from saliva sample


Main biochemical composition:
It consists of tapes, plastic cards, desiccant and aluminium foil bags. The tapes consist of plastic backing, colloidal nanocarbon backing, cellulose sheets, insertion and absorption swabs. The colloidal nanocarbon swabs are coated with nanocarbon monoclonal antibodies against N and S antigens and a nitrocellulose detection line. The control line is a goat anti-mouse IgG antibody.


Storage conditions and expiry date:
The product should be stored at 2°C-30°C in a dry place and protected from light; the expiry date is 12 months from the date of manufacture and the product must not be frozen. The product should be used within one hour after opening the aluminum foil bag; if the aluminum foil bag is opened in a high humidity environment, the product should be used immediately. Do not use after the expiry date.


Sample requirements:
Saliva samples can be stored at 2°C-8°C for up to 48 hours before testing. For long-term storage, samples can be frozen and stored at temperatures below -20°C. Frozen samples should be thawed and mixed before testing.


Test method:
The saliva sample should be warmed to room temperature (20-30°C) before testing. Do not open the bags until you are ready to do the testing.

  1. Remove the test cartridge from its packaging and place it on a clean, flat surface.
  2. Place the tongue on the upper jaw and lower the head so that saliva is naturally secreted into the disposable plastic cup.
  3. Insert the suction rod vertically into a disposable plastic cup with a saliva sample (at least 2 ml). Hold the suction stick immersed in saliva for at least two minutes. During this time, the suction rod may be moved slightly to help it absorb the liquid. When the liquid appears in the viewing window, perform the test and place it on a clean, flat table and start timing.
  4. Check the result 15 minutes after adding the samples. Do not read the results after 30 minutes.


Explanation of the test results:
Positive:
Two lines appear. One black line should be in the control area (C) and another apparent black line should be in the test area (T). This positive result indicates that the SARSCoV-2 N/S antigen is present in the saliva sample.

Negative:
One black line appears in the control area (C) and no line appears in the test area (T). This negative result indicates that the SARS-CoV-2 N/S antigen is not present in the saliva sample or the antigen concentration is too low.

Invalid:
The control line does not appear. The most likely reasons for the line not appearing are insufficient sample volume or incorrect collection procedure. Check the procedure and repeat the test with a new test medium. If the problem persists, discontinue use of the lot and contact your local distributor.

Remark:
The color shade in the test line area (T) will vary, but even if there is only a faint black line, the result should always be considered positive

If you have special requirements for antigen tests and protective equipment or are interested in more information, please contact us.

 

Parameters
Packaging 50pcs, 100pcs, 200pcs, 500pcs, 1000pcs
Printing without print
Packaging 50pcs, 100pcs, 200pcs, 500pcs, 1000pcs
Printing without print

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