Package and specification

20 Tests/box (1Test/bag ×20 Bags)

 

Intended use

For in vitro qualitative detection of SARS-CoV-2 nucleocapsid antigen in nasal (NS) swab specimens directly from individuals who are suspected of COVID-19 by their healthcare provider within the first 5 days after onset of symptoms. This test is only provided for use by clinical laboratories or to healthcare workers for point-of-care testing, not for at-home testing.

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, or 2019-nCoV) is an enveloped non-segmented positive-sense RNA virus. It is the cause of coronavirus disease (COVID-19), which is contagious in humans. SARS-CoV-2 has several structural proteins including spike (S), envelope (E), membrane (M), and nucleocapsid (N).

The antigen is generally detectable in upper respiratory samples during the acute phase of infection. Positive results indicate the presence of viral antigens, but the clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out a bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease.
Negative results should be treated as presumptive, which do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Negative results should be considered in the context of a patient’s recent exposures, history, and the presence of clinical signs and symptoms consistent with COVID-19, and confirmed with a molecular assay, if necessary, for patient management.

For in vitro diagnostic use only. For professional use only

 

Test principle

JOYSBIO Biotechnology’s SARS-CoV-2 Antigen Rapid Test Kit uses an immunocapture method, it is designed to detect the presence or absence of SARS-CoV-2 nucleocapsid proteins in respiratory samples from patients with signs and symptoms of infection who are suspected of COVID-19.
Key components: the anti-nucleocapsid protein antibody and chicken IgY labeled by colloidal gold, the nitrocellulose membrane coated with anti-nucleocapsid protein antibody, and goat anti-chicken IgY antibody.

When specimens are processed and added to the test device, SARS-CoV-2 antigens present in the specimen bind to antibodies conjugated to colloidal gold in the test strip. The antigen-conjugate complexes migrate across the test strip to the reaction area and are captured by a line of antibodies bound on the membrane. A color band will show up when antigen-conjugate is deposited at the Test “T” position and the Control “C” position on the device.

Component20Tests /Kit40Tests /KitMain components
Test card20 Tests/Kit (1Test/bag ×20 Bags)40 Tests/Kit (1Test/bag ×40 Bags)The anti-nucleocapsid protein antibody and chicken IgY labeled by

Specimen collection and handling

1.Specimen Collection and Preparation

Acceptable specimens for testing with this kit include nasal swab specimens obtained by the dual nares collection method. Correct specimen collection and preparation methods must be followed. Specimens obtained early during symptom onset will contain the highest viral titers; specimens obtained after five days of symptoms are more likely to produce negative results when compared to an RT-PCR assay. Inadequate specimen collection, improper specimen handling and/or transport may yield a falsely negative result; therefore, training in specimen collection is highly recommended due to the importance of specimen quality for generating accurate test results.

2. Specimen Transport and Storage

Freshly collected specimens should be processed as soon as possible, but no later than one hour after specimen collection. Correct specimen collection and preparation methods must be followed.

COVID-19 Rapid Swab Test Procedure

step1

Twist off the cap of the buffer bottle, carefully dispense all buffer into the extraction tube

step2

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.

step34

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.

step5

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.

step6

Read the test results between 15 and 20 minutes. Do not read the results after 20 minutes.

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.

Limitations of test method

  1. This product is only suitable for a qualitative test and auxiliary diagnosis.
  2. The test results are only for clinical reference and should not be the only basis for clinical diagnosis and treatment. The clinical management of patients should be considered in combination with their symptoms, physical signs, medical history, other laboratory tests, therapeutic reaction, and epidemiological information.
  3. Users should test specimens as quickly as possible after specimen collection.
  4. Positive test results do not rule out co-infections with other pathogens.
  5. Results from the test should be correlated with the clinical history, epidemiological data, and other data available to the clinician evaluating the patient.
  6. A false-negative test result may occur if the level of viral antigen in a sample is below the detection limit of the test or if the sample was collected or transported improperly; therefore, a negative test result does not eliminate the possibility of SARS-CoV-2 infection.
  7. The amount of antigen in a sample may decrease as the duration of illness increases. Specimens collected after day 5 of illness are more likely to be negative compared to an RT-PCR assay.
  8. Failure to follow the test procedure may adversely affect test performance and/or invalidate the test result.
  9. The contents of this kit are to be used for the qualitative detection of SARS-CoV-2 antigens from nasal swab
    specimens only.
  10. The kit performance depends on antigen load and may not correlate with other diagnostic methods performed on the
    same specimen.
  11. Negative test results are not intended to rule in other non-SARS-CoV-2 viral or bacterial infections.
  12. Positive and negative predictive values are highly dependent on prevalence rates. Positive test results are more likely to represent false-positive results during periods of little/no SARS-CoV-2 activity when disease prevalence is low. False-negative test results are more likely when the prevalence of disease caused by SARS-CoV-2 is high.
  13. This kit has been evaluated for use with human specimen material only.
  14. Monoclonal antibodies may fail to detect or detect with less sensitivity, SARS-CoV-2 viruses that have undergone minor amino acid changes in the target epitope region.
  15. The performance of this test has not been evaluated for use in patients without signs and symptoms of respiratory
    infection and performance may differ in asymptomatic individuals.
  16. The sensitivity of the test after the first five days of the onset of symptoms has been demonstrated to decrease as compared to an RT-PCR SARS-CoV-2 assay.
  17. Negative results should be treated as presumptive and confirmed with an FDA authorized molecular assay, if necessary, for clinical management, including infection control.
  18. Specimen stability recommendations are based upon stability data from influenza testing and performance may be different from SARS-CoV-2. Users should test specimens as quickly as possible after specimen collection, and within one hour after specimen collection.

 

According to the clinical analysis of 150 samples, the results for 1-5 days from symptom onset, the detection sensitivity is 88.89%, 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%

 

Warnings

  1. A negative result can occur if the SARS-CoV-2 virus present in the specimen is below the sensitivity of the kit.
  2. Not for the screening of donated blood.
  3. Do not smoke, drink, or eat in areas where specimens or kit reagents are being handled.
  4. Dispose of all specimens and materials used to perform the test as biohazardous waste.
  5. Handle the negative and positive controls in the same manner as patient specimens for operator protection.
  6. Do not perform the test in a room with strong airflow, i.e. an electric fan or strong air-conditioning

 

Limit of Detection (ANALYTICAL SENSITIVITY)

The LOD for the SARS-CoV-2 antigen rapid test kit is 1.6 x 102TCID50/ mL.
The LOD for the SARS-CoV-2 antigen rapid test kit was established using limiting dilutions of a viral sample inactivated by gamma irradiation. The material was supplied at a concentration of 1.3 x 106 TCID50/mL. In this study, designed to estimate the LOD of the assay when using a direct nasal swab, the starting material was spiked into a volume of virus dilution in saline. An initial range-finding study was performed testing devices in triplicate using a 10-fold dilution series. At each dilution, 50 μL samples were added to swabs and then tested using the procedure appropriate for patient nasal swab specimens. A concentration was chosen between the last dilution to give 3 positive results and the first to give 3 negative results. Using this concentration, the LOD was further refined with a 2-fold dilution series. The last dilution demonstrating 100% positivity was then tested in an additional 20 replicates tested in the same way.

Hook Effect

As part of the LoD study, the highest concentration of the sample (1.3 x 106 TCID50/mL) was tested. There was no Hook effect detected.