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Antigen Rapid Test Kit

Coronavirus Antigen Rapid Test Kit

In June 2020, JOYSBIO Biotechnology proudly released a new COVID-19 Antigen Rapid Test Kit (Colloidal Gold). The new coronavirus antigen test kit is a lateral flow immunoassay for the qualitative detection of SARS-COV-2 antigen (nucleocapsid protein) in upper respiratory specimens with nasal swab or saliva during the acute phase of infection. An uncut sheet format is available.

Properties

15-minute rapid detection
Simple to Operate Coronavirus Antigen Test
Less-invasive nasal (NS) swab sample collection
CE-IVD Marked
Available in 1/2/5/20 trial/box

Display Properties

JOYSBIO’s coronavirus Ag test kit was independently evaluated at Centro Diagnostico Delta Srl in Italy between October 2020 and January 2021. A total of 107 positive samples were tested with JOYSBIO’s COVID-19 Antigen Rapid Test Kit. These samples were collected from patients who are suspected of COVID-19 with swelling in the nose. The sensitivity and specificity of the Coronavirus Antigen Test Kit is compared with the CE-IVD marked RT-PCR Test Kit. This clinical evaluation is done under the assumption that SARS-CoV is no longer spreading in the community.

rapid SARS-CoV-2 antigen detection assay
rapid SARS-CoV-2 antigen detection assay

According to the clinical analysis of 492 samples, the detection sensitivity is 98.13%, and the specificity is 99.22%.

  • Positive Percent Agreement (PPA) = 105/107 (98.13%) (95%CI: 93.4%~99.8%)
  • Negative Percent Agreement (NPA) = 382/385 (99.22%) (95%CI:97.7%~99.8%)
  • Accuracy = (105+382)/492×100%=98.98%
  • Kappa = 2×(105×382-3×2)/(108×385+107 ×384) = 0.97>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.

Rapid-Test-Kits
Rapid-Test-Kits
  1. Twist off the cap of the buffer bottle, carefully dispense all buffer into the extraction tube。 
  2. 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. 
  3. Remove the swab while squeezing the sides of the tube to extract the liquid from the swab. 
  4. Press the nozzle cap firmly onto the extraction tube. Mix thoroughly by swirling or flicking the bottom of the tube. 
  5. 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.
  6. Read the test results between 15 and 20 minutes. Do not read the results after 20 minutes.

 

Stage 1: Nasopharyngeal swab specimen collection:
1. Collect a nasopharyngeal swab specimen by inserting the sterile swab into the nostril.
2. Push the sterile swab until resistance is met at the level of the turbinate.
3. Rotate the sterile swab several times against the nasopharyngeal wall & leave in the place for 10 seconds to saturate the swab tip.
4. Remove the swab from the nostril carefully.
5. Place the swab specimen into the viral transport medium buffer tube and close the tube tightly.
6. Transport the swab sample in VTM to the laboratory in cold chain.
7. The sample can be stored in the Room temperature (Below 30◦C) up to 24 hrs from the time of sample collection or at 2 – 8◦C for up to 48 hrs from the time of sample collection.

Stage 2: Sample preparation for testing:

1. Sample preparation needs to be performed in BSL-2 level cabinet in the Laboratory.
2. Mix the swab specimen in VTM tube well (vortex approximately 3-5 seconds).
3. Transfer 100 μL VITROS® SARS-CoV-2 Antigen Extraction Buffer into a labelled new sample tube.

4. Add 400 μL viral sample to the above tube (to maintain 1:4 ratio of extraction buffer: sample)
5. Mix well (Cap/Plug the sample tube and vortex approximately 3-5 seconds)
Stage 3: Sample processing in VITROS® systems:
1. Place/load the prepared/extracted sample tube in stage 2, after de-capping on to the VITROS® instrument V3600/V5600/XT7600; An amount of 80 μL of extracted sample is used for each determination.
2. Program VITROS 3600 / VITROS 5600 / VITROS XT 7600 system to process the samples for CV2Ag. The system can used to program test either in a STAT/Random/Batch mode.
3. System processes the samples automatically using disposable VersaTips for both sample as well as reagents to prevent any cross-contamination. The results will be delivered in 48 minutes after sample aspiration, in the form of S/Co value.

 

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