Antigen Rapid Test Kit (Beier)

COVID-19 Antigen Rapid Test Kit (Beier)

Produkteigenschaften

The Beier COVID-19 Antigen Rapid Test Kit is an immunochromatographic kit intended for the direct and qualitative detection of SARS-CoV-2 nucleocapsid antigens in nasopharyngeal and oropharyngeal swabs from people who have been treated by their healthcare provider under COVID-19- Are suspected. The test is intended to be used as an aid in diagnosing the coronavirus infectious disease (COVID-19) caused by SARS-CoV-2. The COVID-19 Antigen Rapid Test Kit does not differentiate between SARS-CoV and SARS-CoV-2. The results are for the identification of SARS-CoV-2 nucleocapsid protein antigen. Antigen is usually detectable in the upper respiratory level during the acute phase of the infection. Positive results suggest the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Negative results do not rule out COVID-19 and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. For in-vitro diagnostics only. For professional use only.

Specification

1. Sensitivity 96,5%
2. Specificity 99,7%

Empfindlichkeit und Spezifität

474 klinische Fallproben, die 171 bestätigte Fallproben* und 303 bestätigte ausgeschlossene Fallproben* umfassten, wurden gewonnen oder getestet und verglichen dann die Testergebnisse zwischen dem COVID-19 Antigen Rapid Test Kit und den bestätigten Fallproben. Die Ergebnisse der Empfindlichkeit und Spezifität zwischen den beiden Methoden sind unten dargestellt.

*Bestätigte Fälle waren die Patienten, die gemäß dem Behandlungsplan und dem PCR-Ergebnis diagnostiziert wurden.
*Bestätigte ausgeschlossene Pflegen wurden durch negative PCR-Ergebnisse identifiziert.

ProduktnameProben-Typ Lagertemperatur Packungs-Größe
COVID-19 Antigen Rapid Test Kit (Beier) Naso/Oropharyngeal Abstrich-Probee Bei 2°C -30°C 20 Tests / Kit

Bestell-Nummer:  S-CoV-2-BERT (Kit mit 20 Tests)
Preis: Ab 4,50€ pro Test

Packungsinhalt

Nr. Inhalt Menge
1Beipackzettel 1 Kopie
2Arbeitsstation 1
3Testkassette 25 Kassetten
4Sterile Tupfer 20
5Extraktionspuffer (Phiole) 20
6Reaktionsröhrchen und Tropfspitze 20/20

Precautions

  1. This kit is only intended for in vitro diagnostics and for use by healthcare professionals and professionals at the care locations.
  2. Do not touch the reaction area of the test strip.
  3. Please read all information in this leaflet before performing the test.
  4. The test cassette should remain in the sealed pouch until use.
  5. All specimens should be considered potentially hazardous and treated in the same way as an infectious agent.
  6. Do not use the test kit beyond the expiration date.
  7. To avoid erroneous results, the sample must be processed as described in the test procedure.
  8. The tests should be performed by professionally trained personnel working in certified laboratories or clinics where the sample (s) are collected by qualified medical personnel. Wear protective clothing such as lab coats, disposable gloves, and eye protection.
  9. Do not reuse any part of the kit.
  10. Use the swab provided in the kit when collecting a specimen. Using alternative swabs can lead to wrong ones.
  11. The test result should be interpreted by the physician in conjunction with clinical findings and other laboratory test results.
  12. Disposal of Diagnosis: All samples and the used kit carry a risk of infection. The used test cassette should be disposed of in accordance with federal, state, and local regulations.

Quick Guide Oropharyngeal Swab

  • Do not touch the tongue, cheeks, or teeth with the swab.
  • Insert the sterile swab through the mouth opening of the patient up to the back of the throat.
  • Dab the surface of the back of the throat.
  • Remove the sterile swab from the oral cavity.
  • Please read the package insert for exact use

or

Quick Guide Nasopharyngeal Swab

  • Blow your nose
  • Tilt your head slightly back and support it with a non-dominant hand
  • Insert the swab almost horizontally along the nasal septum deep into the nose to the wall of the throat
  • Swab should reach a depth that corresponds to the distance from the nostril to the outer opening of the ear.
  • Gently rotate the swab for 5–10 seconds to detach epithelial cells.
  • Please read the package insert for exact use
Freshly collected samples should be processed as soon as possible. The oropharyngeal or nasopharyngeal swabs are stable for up to 24 hours at room temperature or 2 ° C to 8 ° C.

Use of the Test Kits

test-1

A

Add 300 µl (contents of one vial) Extraction Buffer (approx. 10 drops) to the test tube.

B

Dip the naso /oropharyngeal swab into the test tube with the extraction buffer.

C

Turn the swab at least 10 times and press firmly against the side of the tube.

D

Squeeze the sides of the tube to get as much liquid as possible.

E

Place the cap on the tube with the sample and hold the tube upright. Add 8 drops (approx. 80 µl) of the sample without air bubbles to the sample well on the test chip

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.

Ivalid:

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.