描述
Performance Characteristics
Coronavirus Ag test kit was independently evaluated at Centro Diagnostico Delta S.r.l. in Italy. A total of 78 positive specimens were tested with JOYSBIO’s COVID-19 Antigen Rapid Test Kit. These specimens were collected from patients who are suspected of COVID-19 with nasal swabs. The coronavirus antigen test kit’s sensitivity and specificity are compared against a CE-IVD marked RT-PCR test kit. This clinical evaluation is conducted under the assumption that SARS-CoV is no longer spreading in the community.
According to the clinical analysis of 190 samples, the detection sensitivity is 98.72%, and the specificity is 97.32%.
- Positive Percent Agreement (PPA) = 77/78(98.72%)(95%CI: 93.0%~100.0%)
- Negative Percent Agreement (NPA) = 109/112(97.32%)(95%CI:92.4%~99.4%)
- Accuracy = (77+109)/190×100% = 97.89%
- Kappa = 2×(77×109-3×1)/(80 ×112+78 ×110) = 0.96＞0.5
The limit of detection (LOD) of this product is 1.6 x 102 TCID50/mL, calculated through a gradient dilution method.
COVID-19 Antigen Rapid Test Principle
The coronavirus antigen rapid test kit is a lateral flow assay that qualitatively detects the presence of nucleocapsid (N) protein in upper respiratory samples (nasal swabs). This lateral flow assay is designed with the sandwich immunoassay format. When the specimen is added onto the sample pad of a test cassette, coronavirus N protein binds with colloidal gold-labeled SARS-CoV-2 N protein antibody to form an antibody-antigen (Ab-Ag) complex. The Ab-Ag complex is captured by SARS-CoV-2 N protein antibody (Rabbit monoclonal antibody) when migrating to the test line under capillary action. A red-colored band will appear on the test line, which indicates the specimen is COVID-19 nucleocapsid protein positive. No color band will appear on the test line if the specimen does not contain any coronavirus antigen (N protein), or the antigen level is below detection limit.
The conjugation pad also contains colloidal gold-labeled chicken IgY, which is captured by Goat anti-chicken IgY on the control line as procedural control. A colored band on the control line represents the proper liquid flow through the cassette; the absence of a colored band on the control line indicates insufficient sample or buffer volume.
COVID-19 Antigen Test Procedure
- Twist off the cap of the buffer bottle, carefully dispense all buffer into the extraction tube。
- After collecting upper respiratory sample with nasal swab, insert the swab into the extraction tube, plunge the swab up and down in the fluid for a minimum of 10 seconds. Hold the swab against the bottom of the tube, rotate three turns. DO NOT splash liquid out of the tube.
- Remove the swab while squeezing the sides of the tube to extract the liquid from the swab.
- Press the nozzle cap firmly onto the extraction tube. Mix thoroughly by swirling or flicking the bottom of the tube.
- Gently squeeze the tube’s rigid body, dispense two (2) drops of the buffer-specimen mixture into the sample well on the coronavirus antigen test cassette.
- Read the test results between 15 and 20 minutes. Do not read the results after 20 minutes.
How to Use a COVID-19 Antigen (Ag) Rapid Test Kit : – https://www.youtube.com/watch?v=y7xTEnKnjFo
SPECIFICATION:
- TEST TIME: 15–20 MINUTES
- STORAGE CONDITION: 2°C–30°C
- CE MARK
- SAMPLE TYPE: Nasal (NS) swab
- SHELF LIFE: 24 months
CONTENTS:
20x Test Devices
20x Buffer Bottle (350 μL/bottle)
20x Extraction Tubes and Nozzle Caps
20x Sterilized Nasal (NS) Swabs
1x Tube Rack
1x Instructions for Use
Positive/Negative Control Swabs (upon request)
Package:
20pcs /Box
1000pcs / 50 Boxes / 1 Carton
Carton Size: 430 × 530 × 630mm
Carton N.W : 17.5kg
