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Nantong Diagnos Biotechnology Co.,Ltd. - COVID-19 Antigen Saliva Test Kit (Colloidal Gold)

BfArM: AT517/20

Produktbeschreibung
SARS-CoV-2-Diagnose-Antigen-Schnelltest: 25 Einheiten pro Karton; Entspricht CE; Qualitätsstandards: EN ISO 13485: 2016; EN ISO 15223-1: 2016; EN 13612: 2002; EN 13641: 2002; EN 13975: 2003; EN ISO 14971: 2012; EN ISO 18113-1: 2011; EN ISO 18113-2: 2011; EN ISO 23640: 2015; EN ISO 17511: 2003; EN 62366: 2008.

Gebrauchsanleitung: https://arbitrage-medical.de/shop/media/pdf/21/22/64/DiagnosCgloC2rqwCAR4.pdf

Manufacturer performance data
SENSITIVITY 98.1%
SPECIFICITY 99.33%

REGULATORY STATUS
CE-IVD
Germany BfArM

TIME TO RESULT
0.25

ASSAY TARGET
Antigen

TEST FORMAT
Lateral flow assay (strip or cassette)

TECHNOLOGY PRINCIPLE
Antibody-based detection
TARGET ANALYTE
N protein
LEVEL OF AUTOMATION
Manual
LABORATORY/POINT-OF-CARE
True Point of Care
SELF-TESTING/SELF-COLLECTION
Intended for self-testing (in development)
VALIDATED SAMPLE TYPES
Saliva
CONNECTIVITY
No
IMPACT OF SARS-COV-2 VARIANT:
Alpha - No impact (analytical/clinical studies conducted)
Beta - No impact (analytical/clinical studies conducted)
Gamma - Unknown

1. Anterior nasal secretions collection
(1)Blow your nose before collecting a sample. Gently insert the swab into the
nostril. The swab tip should be inserted 2 to 2.5 cm from the edge of the
nostril.
(2)Slowly twist the swab, rubbing it along the insides of the nostril for 15
seconds. (approximately 5 times).
(3)Gently remove the swab.
(4)Using the same swab, repeat steps (1)~(3) in the other nostril.
2. Throat secretions collection:
(1)Insert the swab completely from the mouth into the throat, centering on the
red part of the throat wall and maxillary tonsils.
(2)Rub the bilateral throat tonsils and throat wall moderately.
(3)Avoid touching the tongue and remove the swab.
3. Nasal secretions collection
(1)Carefully insert the swab into the nostril of the patient, reaching the surface
of posterior nasopharynx. That presents the most secretion under visual
inspection.
(2)Swab over the surface of the posterior nasopharynx. Rotate the swab
several times.
(3)Withdraw the swab from the nasal cavity.