SARS-CoV-2 Rapid CAT,
Antigen testing kit

We have all the answers

Frequently Asked Questions

How does the test casette work?

Wollerau Pharma RAPID CAT COVID-19 Antigen Complete Testing Kit is a double antibody-sandwich, qualitative membrane-based immunoassay In-vitro diagnostic medical device. The kit is designed to detect nucleocapsid antigen from the SARS-CoV-2 in nasopharyngeal swab or oropharyngeal swab from patients who are suspected of being COVID-19 positive. The SARS-CoV-2 antigens present in the specimen react with anti- SARS-CoV-2 antibody-coated particles in the test cassette. The mixture then migrates upward on the membrane by capillary action and reacts with the pre-coated antibody in the test line region. If the specimen contains SARS-CoV-2 antigens, a coloured line will appear in the test line region. If the specimen does not contain SARS-CoV-2 antigens, no coloured line will appear in the test line region, indicating a negative result. To serve as a procedural control, a coloured line will always appear in the control line region, indicating that the proper volume of specimen has been added and membrane wicking has occurred.

What are Antigen?

Antigens are viral proteins. SARS-CoV-2, the virus that causes COVID-19, has several known antigens. In response to the exposure of antigens, B cells of the immune system produce Y-shaped protein antibodies.

Is the test specific for COVID-19?

The SARS-CoV-2 anitgen that the test detects is the specific virus that causes the COVID-19 disease, so a positive result would indicate the presence of the virus that is to develop the infection. The test can be used for primary and secondary diagnosis of presence of SARS-CoV-2.

What samples can I use?

The test cassette will work with nasopharyngeal and oropharyngeal samples. 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 antigen. We recommend that you only use the buffer solution provided with the test kits, as other ones may affect the accuracy of the test.

I didn't read the results after 30 minutes. What should I do?

For the result, the window of accuracy is 15-30 minutes after you add the sample and buffer solution. If you forget to read the results after this time, the test may not be accurate and should be disposed in biological waste. You should retest with a new Rapid CAT.

What is the shelf-life of the test cassette?

The shelf-life is 18 months from the date of manufacture. The product expiry is printed onto the packaging for reference. Do not use after the expiry date.

How should I store the tests?

The recommended storage temperature is 2 – 30°C, however, we do not recommend you store them in the fridge, unless there is a risk of them overheating. Do not freeze the test cassettes or buffer solution. Tests should be performed at room temperature (15 – 30°C), so if you have stored tests in the fridge, you should allow them to reach room temperature before performing a test.

Can babies and young children be tested?

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

Can pregnant or breast feeding 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.

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

Yes, the SARS-CoV-2 Rapid CAT is CE marked for professional use and is therefore a registered IVD device, according to the requirements in the In Vitro Diagnostic Medical Device Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998. The test kit holds a Certificate of Free Sale issued by United Kingdom Medicines and Healthcare products Regulatory Agency (UK Medical Devices Regulations 2002 S.I. No. 618, as amended) and therefore may be freely sold in all member states of the European Economic Area including the United Kingdom.

Is the product already on the market, e.g. in Great Britain?

The test kit is sold throughout the United Kingdom, Europe, Africa and Euroasia.

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.

We SHOW you how it's done!

Instructions for Use

Product Manual

View the Rapid CAT user manual.

  1. Carefully read the Instructions for Use of SARS-CoV-2 Rapid Antigent Test
      1. Check the EXPIRY DATE on the sachet. Discard the test if expiry date has passed.
          1. Open the foil pouch and remove the cassette, and gel envelope.
              1. Ensure the cassette is undamaged.
                  SECTION 2 - NASOPHARYNGEAL 
                  SWAB PROCEDURE
                  1. Encourage the patient to blow his her nose to clear nasal passage. Label the cassette with the patients name, and time of test. Perform hand hygiene. Put on a mask, eye protection and gloves.

                    With the person's head in a neutral position
                    Insert the dry swab through one nostril upwards, along the floorof the nasal passage until you reach the posterior wall of the nasopharynx - generally one half the distance from the corner of the nose to the front of the ear (about 4 to 6 cm)

                    Rotate the swab gently then leave in place a few seconds
                    Carefully remove the swab without touching the sides of the nostril. Specimens can be collected from both sides using the same swab, but it is not necessary to collect specimens from both sides ifthe minitip is saturated with fluid from the first collection. If a deviated septum or blockage createdifficulty in obtaining the specimen from one nostril, use the same swab to obtain the specimen from the other nostril.
                      SECTION 3 - PREPARATION FOR TEST
                      1. Open the reagent tube/dropper. If separate reagent bottles are provided, transfer reagent solution from the reagent bottle to the reagent tube.
                          1. Insert the swab in the reagent medium. Leave the swab in the reagent tube/dropper for 1 minute. While squeezing the buffer tube, stir the swab 3 times or more.
                              1. Remove the swab while squeezing the reagent tube/dropper, to extract liquid from the swab.
                                  1. Press the nozzle cap tightly onto the reagent tube/dropper.
                                      1. Firmly squeeze the reagent tube/dropper to apply three drops of the specimen into the specimen well (S) of the test cassette, then start the timer. Read the test at 15 to 30 min.
                                          WARNING: Risk of incorrect results. Do not read the test result after 30 min.
                                          SECTION 4 - INTERPRETING RESULTS
                                          1. A coloured line (control line) appears in the top section of the cassette to show that the test is working properly. This is the control line (C).

                                            Even if the control line is faint, the test should be considered to have been performed properly. If no control line is visible the test is invalid.

                                            In case of a positive result, a coloured line appears in the lower section of the result window. This is the test line (T).

                                            Even if the test line is very faint or not uniform, the test result should be interpreted as a positive result

                                              We provide an overview of what is inside!

                                              Kit Content

                                              WPCV0101B Rapid CAT (per box, non reusable)

                                              - 20x Rapid CAT Cassette
                                              - 20x Reagent tube/dropper
                                              - 2x Reagent bottles
                                              - 20x Sterilised nasopharyngeal swab

                                              WPCV0101MB Rapid CAT (per box, non reusable)

                                              - 20x Rapid CAT Cassette
                                              - 20x Reagent tube/dropper
                                              - 2x Reagent bottles
                                              - 20x Sterilised oropharyngeal swab