Antigen Rapid Test Kit (Realy Tech)

COVID-19 Antigen Rapid Test Kit (Realy Tech)

Product characteristics

The Realy COVID-19 rapid antigen test is a rapid, chromatographic test for the qualitative detection of SARS-CoV-2 virus antigens with swabs in the human (naso / oro) -pharyngeal in people with suspected SARS-CoV-2 infection.

  • Listed on the list of the BfArM (AT 015/20)
  • Refundable under the test regulation – High specificity (> 99.9%)
  • High sensitivity with high viral load: 96.17% (ct value: 20-30)
  • Easy handling
  • Reliable result after only 5-10 minutes
  • May only be used by healthcare professionals
  • Only low viral load required for detection
  • Infected people can be identified before they develop symptoms
  • TÜV and CE certified test

Indication for Testing

  •  To detect infection after contact with COV-2 infected persons
  • At or before onset of symptoms in addition to PCR test.
  • As a precaution before meeting third party
  • If no PCR test is accessible.
  • As a precaution in case of uncertainty if infection took place.
  • As a follow up after being PCR positive tested, to monitor the status if potentially still infective.

Specifications

  1. Sensitivity: 96,17%
  2. Specificity: 99,9%

Performance characteristics

Clinical evaluation was performed to compare the results obtained by Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Cassette (swab) and PCR. The results were summarized below: Table: Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Cassette (swab) vs. PCR
Method 2019-nCoV Nucleic Acid
Test Kit (RT-PCR)
 Total Results
The Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Cassette (Swab)ResultsPositiveNegative
Positive2010201
Negative8450458
Total Results209450659

Clinial sensitivity = 201/209=96.17% (95%CI*92.51% to 98.17%)
Clinial sensitivity = 450/450=99.9% (95%CI*98.48% to 100%)
Accuracy: (201+450)/(201+0+8+450) *100%=98.79% (95%CI*97.58% to 99.43%)

Order Number: S-CoV-2-RERT (Kit with 25 tests)
Price: From 4,25€ per test

Product Name Sample Type Storage Temperature Packaging Size
COVID-19 Antigen Rapid Test Kit (Realy Tech)
Naso/Oropharyngeal swab sample Store at 2°C – 30°C 25 Tests / Kit
NoContentQuantity
1Instructions for use 1 copy
2Workstation 1
3Test cassette 25 cassettes
4Sterilized Swab 25
5Reagent solution phial 25
6Reagent tube and drip tip 25/25

Specimen Collection

  • Do not touch your tongue, cheeks, or teeth
    with the swab.
  • Insert the sterile swab through the mouth opening of the patient to the back of the throat.
  • Dab the surface of the back of the throat.
  • Pull the sterile swab out of the oral cavity.
  • For the exact application, please read the package insert

or

Quick Guide Nasopharyngeal Swab

  • Let blow the nose
  • Tilt head slightly back and support it with the non-dominant hand
  • Insert the swab almost horizontally along the nasal septum deep into the nose up to the pharynx wall
  • Gently rotate the swab for 5–10 seconds to detach epithelial cells.
  • For the exact application, please read the package insert

Test Procedure

A

Add 300ul (1 phial) extraction buffer (approximately 10 drops) into the reagent tube.

B

Add the Naso-/oropharyngeal swab to the tube with extraction buffer.

C

Vigorously rotate and twist the swab against the side of the tube at least 10 times.

D

Squeeze the sides of the tube to obtain as much as liquid as possible. Dispose the swab properly.

E

Apply the cap to the tube with specimen, an hold the tube verticaly, add 3 drops (about 80 µl) of the specimen without air bubbles into the sample well.

Result Interpretation

Negative:

A pink colored band appears only at the control region (C), indicating a negative result for COVID-19 Infections.

Positive:

A clear pink control band (C) and a detectable test band (T) appears, indicating a positive result for COVID-19 infections.

Invalid:

No visible band appears at the control region. Repeat with a new test kit. If the test still fails, please contact the distributor with the lot number.