Description

SENSITIVITY: 98.72% (100% for samples
with Ct values ≤33)

SPECIFICITY: 97.32%

CLINICAL STUDY POPULATION: 190
individuals, including 78 PCR-positives and
112 PCR-negatives

CLINICAL STUDY DATE & LOCATION:
November 2020 Apollosa (Benevento) Italy

PERFORMANCE*:

TEST TIME: 15–20 MINUTES
STORAGE CONDITION: 2°C–30°C
CE MARK
SAMPLE TYPE: Nasal (NS) swab
SHELF LIFE: 24 months
SPECIFICATION:

10x Test Devices
10x Buffer Bottle (350 μL/bottle)
10x Extraction Tubes and Nozzle Caps
10x Sterilized Nasal (NS) Swabs

Instructions for Use

For in vitro qualitative detection of SARS-CoV-
2 nucleocapsid antigen in nasal (NS) swab

specimens directly from individuals who meet
COVID-19 clinical and / or epidemiological
criteria. JOYSBIO COVID-19 Antigen Rapid Test
Kit is for professional use only and is
intended to be used as an aid in the diagnosis
of SARS-CoV-2 infection. The product may be
used in any laboratory and non-laboratory
environment that meets the requirements
specified in the Instructions for Use and local
regulation.