Rapid Nasal and Rapid Saliva Tests
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. An uncut sheet format is available.
Antigen 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 Aicone’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.
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 tract specimens (nasal swabs). This lateral flow assay is designed with 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-labelled SARS-CoV-2-N protein antibody and forms an antibody-antigen complex (Ab-Ag).
The Ab-Ag complex is captured by the SARS-CoV-2 N protein antibody (rabbit monoclonal antibody) as it migrates under capillary action to the test line. A red coloured band appears on the test line indicating that the sample is COVID-19 nucleocapsid protein positive.
No coloured band appears on the test line if the sample does not contain coronavirus antigen (N protein) or the antigen content is below the detection limit.
The conjugation pad also contains chicken IgY labelled with colloidal gold, which is detected on the control line as a procedural control of goat anti-chicken IgY. A coloured band on the control line represents proper fluid flow through the cassette; the absence of a coloured 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 pour all the buffer into the extraction tube.
After collecting an upper respiratory tract sample with a nasal swab, insert the swab into the extraction tube, dip the swab up and down into the liquid for at least 10 seconds. Hold the swab against the bottom of the tube and turn it three times. Do NOT squirt any 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 rigid body of the tube and place two (2) drops of the buffer-sample 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. Please read the instructions for use for the complete procedure.
Interpretation of the test results
NEGATIVE: A coloured band appears on the control line (C line); no coloured band appears on the test line (T line). A negative result indicates that no coronavirus antigen (N protein) is present in the sample or the coronavirus antigen content is below the detection limit.
POSITIVE: A coloured band appears on the control line (C line), a second coloured 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 coloured band appears on the control line (C line). An invalid test result indicates insufficient buffer volume or incorrect operation. Carefully review the test procedure and retest the same patient using a different Coronavirus Antigen Rapid Test Cassette. Contact your dealer if the problem persists.
SARS-CoV-2 Antibody Test (colloidal gold immunochromatography)
SARS-CoV-2 Antibody Test (colloidal gold immunochromatography) is a rapid and very simple (only 10 minutes) professional straightforward use with saliva, as well as with naso-/oropharyngeal samples. The use of the SARS-CoV-2 Rapid Antibody Test (colloidal gold immunochromatography) is restricted to healthcare personnel.
High diagnostic sensitivity and specificity.
Results available in 10 min.
- High Sensitivity and Specificity
- Quick results after 10 minutes
- All sample collection and testing material included
- Simple execution protocol
- Single one-step buffer and mixing tubes
- Based on colloidal gold immunoassay technology
|Technology||Lateral flow sandwich immunoassay|
|Sample type||Saliva, naso-/oropharyngeal swab|
26 x 500 μL
|Sample volume||100 μL (3 drops)/test|
| Naso-/oropharyngeal sample: 99.12%
Saliva sample: 99.45%
|Packaging specification||25 tests/kit|