BOSON Rapid SARS-CoV-2 Antigen Test (Home Self-Test) (CE-IVD Certified)1N40C5-2

Boson Rapid SARS - COV-2 Single Antigen Test Kit 1N40C5-2

A home test for the rapid qualitative detection of SARS-CoV-2 virus antigen in anterior nasal swabs within 7 days of symptom onset. Self-test received notified body approved CE marking on April 1, 2021.

Antigen Test Specifications:

• Sample type: nasal swab
• Time to result: 15-20 min
• Sensitivity: 96.77%
• Specificity: 99.20%
• Accuracy: 98.72%

Layperson study statistics for Boston Antigen Test:

• 99.10% of non-professionals carried out the test without requiring assistance
• 97.87% of different types of results were interpreted correctly

Antigen Test Procedures

• Rotate the lid of sample extraction buffer bottle. Caution: Open it away from your face and be careful not to spill any of the liquid.
• Squeeze all extraction buffer out of the bottle into the extraction tube. Caution: Avoid touching the bottle against the tube.
• Squeeze all extraction buffer out of the bottle into the extraction tube. Caution: Avoid touching the bottle against the tube.
• Carefully insert swab into one nostril. The swab tip should be inserted no less than 2.5 cm (1 inch) from the edge of the nostril. Roll swab 3-4 times along the mucosa inside the nostril.
• Leave swab in the nostril for several seconds. Using the same swab, repeat this process for the other nostril.
• Withdraw swab from the nasal cavity. Caution: This may feel uncomfortable. Do not insert the swab any deeper if you feel strong resistance or pain.
• Place swab into extraction tube. Roll swab three to five (3-5) times. Leave swab in extraction buffer for 1 minute.
• Pinch extraction tube with fingers and remove the solution from swab as much as possible.
• Install the nozzle cap onto the sample extraction tube tightly.
• Bring the kit components to room temperature before testing. Open the pouch and remove thecard. Place the card on a flat and level surface. Caution: Once opened, the test card must beused immediately..
• Invert the extraction tube and add 3 drops of test specimen into the specimen well (S) by gently squeezing the extraction tube. Caution: The formation of air bubbles in thespecimen well (S) must be avoided..
• Read the results at 15-20 minutes. Caution: Results after 20 minutes may not be accurate

• Delivery time is 24/48 hours by courier
• For larger volume orders (>1000) we can provide a larger discount – please contact csales@hayesfirstaid.com   

After sales support for the test:

Email: sales@hayesfirstaid.com   

Telephone: (069) 66006 or (01) 5079901

Documentation and Certification

Genrui Antigen Home Test - Instructions For Use (IFU)

Genrui Antigen EU - CE-IVD Certification

EXCELLENT PERFORMANCE CHARACTERISTICS: 

Specificity:  100% 

Sensitivity:  98.13% 

Accuracy:    >99% 

This product is CE-IVD marked for professional use and complies with the European In-Vitro Diagnostic Devices Directive (98/79/EC) for home use. 

About this home test

Genrui SARS-CoV-2 antigen test kit (colloidal gold) is an immunochromatographic assay for rapid and qualitative test of N protein of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) antigen detection in nasal swabs.

This test is applicable to all individuals suspected of being infected by SARS-CoV-2. The test will be used to assist in the diagnosis of the coronavirus infectious disease (COVID-19) caused by SARS-CoV-2.

The test kit is simple, safe, effective and intended for self-testing, which is suitable for individuals to use in non-laboratory settings like homes, offices, schools, sports stadiums, airports, etc.

Test Principle

During the test, the processed samples to be tested are added to the sample holes. When the sample contains SARS-CoV-2 antigen, it first combines with the colloidal gold-labelled anti-SARS-CoV-2 antibody. Chroma-tography is then performed. When it binds to the anti-SARS-CoV-2 monoclonal antibody previously immobilized on another membrane, a purple-red band will appear in the test area (T). If there is no SARS-CoV-2 antigen in the sample, there will be no purple-red band in the test area (T). A purple-red band will appear in the quality control area (C) regardless of the presence of new coronavirus antigen in the sample, which is used as a criterion to determine whether there is sufficient sample or the chromatography is processed properly. It is also used as an internal control standard for the test kit.

EASY TO USE: Easy sampling using nasal swab specimens.

RAPID AND CONVENIENT: Results in 15 minutes. Requires no instruments.

This product is CE-IVD marked for professional use and complies with the European In-Vitro Diagnostic Devices Directive (98/79/EC) for home use. 

SUMMARY

The novel coronaviruses belong to the β genus. COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, patients infected by the novel coronavirus are the main source of infection, Asymptomatic infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases.

So whether you are a home user, medical centre, surgery, first responders, fire service, ambulance service, occupational health department or a nursing home, you can give our team a call on 01 5079901 or contact us to discuss your needs or get a quote.