Rapid test


Coronavirus antigen swab 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 samples of the upper respiratory tract with nasal swabs during the acute infection phase.


characteristics

• Result within 15 minutes

• Easy to use coronavirus antigen test

• Compatible with nasal (NS, inclusive) and nasopharyngeal (NP) swabs

• CE-IVD certified

• Sensitivity 98.72%

• official recommendation from the Federal Institute for Drugs and Medical Devices

• Specificity to COVID-19 99.05%

As of October 2020, JOYSBIO is one of the first manufacturers in China to receive whitelist status from the Chamber of Commerce for the export of COVID-19 antigen rapid test kits. All custom documents can be sent directly from mainland China.


Performance characteristics


JOYSBIO's Coronavirus Ag test kit is being evaluated in Heilongjiang Provincial Hospital, China. A total of 45 positive samples were tested with the COVID-19 Antigen Rapid Test Kit from JOYSBIO. These samples were collected from patients with nasal swabs 1-5 days after the onset of symptoms. The sensitivity and specificity of the coronavirus antigen test kit is compared with a CE-IVD-marked / FDA EUA approved RT-PCR test kit (BGI). This clinical evaluation is conducted on the assumption that SARS-CoV is no longer spreading in the community.

According to the clinical analysis of 150 samples, the results for 1-5 days from the onset of symptoms, the detection sensitivity is 98.72% and the specificity is 99.05%.

•  Positive Percent Agreement (PPA) = 40/45 (88.89%) (95% CI: 75.9% ~ 96.3%)

•  Negative Percent Agreement (NPA) = 104/105 (99.05%) (95% CI: 94.8% ~ 100.00 %%)

•  Accuracy = (40 + 104) / 150 × 100% = 96.00%

•  Kappa = 2 × 4155/9210 = 0.90 > 0.5

The limit of detection (LOD) of this product is 1.6 x 10 2 TCID50 / ml calculated by a gradient dilution method.





COVID-19 quick swab testing procedure

The Coronavirus Antigen Rapid Test Kit is a lateral flow assay that qualitatively detects the presence of nucleocapsid (N) protein in samples from the upper respiratory tract (nasal swabs). This lateral flow assay was developed in the sandwich immunoassay format. When the sample is placed on the sample pad of a test cassette, the coronavirus N protein binds to the 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 antibodies (rabbit monoclonal antibody) as it migrates to the test line under capillary action. A red colored line will appear on the test line, indicating that the sample is COVID-19 nucleocapsid protein positive. No colored line appears on the test line if the sample does not contain any coronavirus antigen (N-protein) or if the antigen level is below the detection limit.

Principle of the Coronavirus Antigen (Ag) rapid test kit:

The sampling pad also contains colloidal gold-labeled chicken IgY, which is captured by Goat anti-chicken IgY on the control line as a procedural control. A colored band on the control line represents the correct flow of fluid through the cassette. The absence of a colored band on the control line indicates insufficient sample or buffer volume.




COVID-19 quick swab testing procedure

  1. Unscrew the lid of the buffer bottle and carefully pour all of the buffer into the extraction tube.
  2. After collecting the upper airway sample with a nasal swab, insert the swab into the extraction tube and soak the swab up and down in the liquid for at least 10 seconds. Hold the swab against the bottom of the tube and turn it three turns. DO NOT squirt any 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 rigid body of the tube and add two (2) drops of the buffer-sample mixture to 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.



Reading the test results


•  NEGATIVE: A colored band appears on the control line (C-line). No colored band is displayed on the test line (T-line). A negative result indicates that there is no coronavirus antigen (N protein) in the sample or that the coronavirus antigen content is below the detection limit.

•  POSITIVE: A colored band appears on the control line (C-line), a second colored band appears on the test line (T-line). A positive result indicates the presence of COVID-19 antigen (N-protein) in the patient sample.

•  INVALID: No colored band appears on the control line (C-line). An invalid test result indicates that there may be insufficient buffer volume or incorrect operating procedures. Review the testing procedure carefully and retest the same patient with a different Coronavirus Antigen Rapid Test Device. Contact your dealer if the problem persists.



What is the difference between the COVID-19 PCR test, antigen test and antibody test?

 There are two types of tests available for COVID-19: virus tests and antibody tests. The RT-PCR test and the antigen test are both virus tests that detect the presence of SAR-CoV-2 from samples from the upper respiratory tract. The RT-PCR test aims at the genomic information of the virus (RNA); However, the COVID-19 Antigen Test Kit detects pieces of protein that make up the SARS-CoV-2 virus. The WHO recommends both RT-PCR tests and antigen tests to diagnose active coronavirus infection. For more information on the basics of coronavirus testing, see the U.S. FDA page.


Can I use this test as a self-test at home?

The COVID-19 Antigen Test Kit is not intended for home use. This test kit must be administered by a healthcare professional. JOYSBIO Biotechnology is working on filing an OTC (over-the-counter) approval. Please check with your local health department or regulatory agency before placing an order.


What is the availability of this product and how long can you deliver to my country?

This product is available now. As a rule, delivery can take place within 1-2 weeks. Please contact us for large order quantities. Our HPS sales team will be happy to help you with bulk orders or dealer discounts.