COVID-19 Antigen Rapid Test Kit -Single Test Individually Wrapped

Product no.: JOYSBIO

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COVID-19 Antigen Rapid Test Kit JOYSBIO

15 Individually Wrapped Tests- Prevent Cross infection

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 Samples with nasal swabs or saliva during the acute
phase of infection

 

Features

  • 15-minute rapid detection
  • Easy-to-operate coronavirus antigen test
  • Less-invasive nasal (NS) swab sample collection
  • CE-IVD marked

 

COVID-19 Antigen Test Procedure

  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.

Please check Instructions for Use for complete procedure

JOYSBIO COVID 19 Antigen Test Operation Procedure
JOYSBIO
 

Interpretation of Test Results

  • NEGATIVE: A colored band appears on the control line (C line); no colored band                                          shows up on the test line (T line). A negative result indicates there is no coronavirus                                        antigen (N protein) in the specimen, or the level of coronavirus antigen is below the                                          detection limit.
  • POSITIVE: A colored band appears on the control line (C line), a second colored band                                  shows up 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                                        suggests there might be insufficient buffer volume or incorrect operating procedures.                                    Carefully review the test procedure and test the same patient again with another                                                coronavirus antigen rapid test cassette. Contact your distributor if the problem persists.
Coronavirus Antigen (Ag) Rapid Test Kit Result Interpretation
 

Performance Characteristics

JOYSBIO’s coronavirus Ag test kit was independently evaluated at Centro Diagnostico Delta S.r.l. in Italy between October 2020 and January 2021. A total of 107 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 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.

 
 

JOYSBIO Coronavirus Antigen Ag Test Kit Clinical Evaluation Data 2021

 

 

COVID-19 Antigen Rapid Test Kit JOYSBIO Instructions pdficon_small

COVID-19 Antigen Rapid Test Kit JOYSBIO- Brochure pdficon_small

 

Pack Size: Single Test (15 Individually Wrapped Tests per Box)

 

 
Coronavirus Antigen (Ag) Rapid Test Kit Principle

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.

 

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