Accu-Tell^® COVID-19 Antigen Cassette (Nasal Swab)

Product Description

STATEMENT:

1. Accu-Tell^® COVID-19 Antigen Cassette (Nasal Swab) is for professional use. It is NOT for self-testing or home use;

2. Any distributor shall notify to your local authority about the product and get the appropriate approval before you import and place the product in your local market;

3. We are not marketing, selling, or distributing Accu-Tell^® COVID-19 Antigen Cassette (Nasal Swab) without FDA clearance in USA.

CATALOG

KEY POINTS

Detection for: qualitative detection of SARS-CoV-2 antigen in Nasal swab. The identification is based on monoclonal antibodies specific to the Nucleocapsid（N）protein of SARS-CoV-2. For professional in vitro diagnostic use only.

Reading time: at 10 minutes

Relative Sensitivity: 93.2% (95%CI*:86.5%-97.2%)

Relative Specificity: 99.2% (95%CI*:97.1%-99.9%)*

Relative accuracy: 97.5% (95%CI*:95.2%-98.8%)*

* Confidence Intervals

Detection Limit: 1000 TCID50/mL.

INTENDED USE

ACCU-TELL^® COVID-19 Antigen Cassette (Nasal Swab) is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 antigen in Nasal swab. The identification is based on monoclonal antibodies specific to the Nucleocapsid（N）protein of SARS-CoV-2. It is intended to aid in the rapid differential diagnosis of COVID-19 infection.

MATERIALS

Materials provided

Materials required but not provided

Timer                                   

SPECIMEN COLLECTION AND PREPARATION

Nasal Swab

Use the nasal swab supplied in the kit. Prior to collecting the nasal swab, the patient should be instructed to blow their nose. To collect a nasal swab sample, insert the entire absorbent tip of the nasal swab (usually ⅗ to 1 of an inch (1.5 to 2.5cm)) inside the nostril and firmly sample the nasal wall by rotating the swab in a circular path against the nasal wall at least 5 times. Take approximately 15 seconds to collect the sample per nostril. Be sure to collect any nasal drainage that may be present on the swab. Sample both nostrils with the same swab before testing.

TEST PROCEDURE

Allow the test, specimen, and extraction buffer to equilibrate to room temperature (15-30℃) prior to testing.

1. Remove the test cassette from the sealed foil pouch and use it within one hour. Best results will be obtained if the assay is performed immediately after opening the foil pouch.

2. Place the extraction tube in the workstation. Turn the hand over and add all extraction buffer (approx. 400μL) to the extraction tube. See illustration 1&2.

3. Place the swab specimen in the extraction tube. Rotate the swab for approximately 10 seconds while pressing the head against the inside of the tube to release the antigen in the swab. See illustration 3.

4. Remove the swab while squeezing the swab head against the inside of the Extraction Tube as you remove it to expel as much liquid as possible from the swab. Discard the swab in accordance with your biohazard waste disposal protocol. See illustration 4.

5. Fit the dropper tip on top of the extraction tube. Place the test cassette on a clean and level surface. See illustration 5

6. Add 3 drops of the solution (approx.80μL) to the sample well and then start the timer. Read the result at 10 minutes. Do not interpret the result after 20 minutes.

PERFORMANCE CHARACTERISTICS

Sensitivity, Specificity and Accuracy

Nasal Swab:

ACCU-TELL^® COVID-19 Antigen Cassette (Nasal Swab) has been evaluated with specimens obtained from different clinical sites where the specimens were collected with Nasal Swabs. The Nasal Swabs were randomised and blind tested by operators following the instructions for use. RT-PCR was used as the reference method for ACCU-TELL^® COVID-19 Antigen Cassette (Nasal Swab). Specimens were considered positive if PCR indicated a positive result.

Relative Sensitivity: 93.2% (95%CI*:86.5%-97.2%)

Relative Specificity: 99.2% (95%CI*:97.1%-99.9%)*
Relative accuracy:97.5% (95%CI*:95.2%-98.8%)*
* Confidence Intervals

Detection Limit

The LOD for ACCU-TELL® COVID-19 Antigen Cassette (Nasal Swab) was established using limiting dilutions of a viral sample inactivated. The material (ZeptoMetrix, 0810587CFHI) was supplied at a concentration of 1.15x107 TCID50/mL. The Estimated LOD is 1000 TCID₅₀/mL.

Cross Reactivity

ACCU-TELL^® COVID-19 Antigen Cassette (Nasal Swab) has been tested for Influenza A virus, Influenza B virus, Adenovirus, Coxsackie virus, Parainfluenza Virus Type1, Parainfluenza Virus Type2, Parainfluenza Virus Type3, Parainfluenza Virus Type4a, Enterovirus, Mumps virus, Respiratory syncytial virus, Rhinovirus, Bordetella pertussis, Haemophilus parainfluenzae, Staphylococcus aureus, Streptococcus agalactiae, Neisseria meningitides, Streptococcus sp. group A, Streptococcus sp. group B, Streptococcus sp. group C, Candida albicans, Human Metapneumovirus (hMPV), Legionella pneumophila, Mycobacterium tuberculosis, Mycoplasma pneumoniae,Pneumocystis jirovecii(PJP)-S cerevisiae Recombinant, Pseudomonas aeruginosa, Staphylococcus epidermis, Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus salivarius, Human coronavirus 229E, Human coronavirus OC43, Human coronavirus NL63, SARS-CoV-1, MERS-coronavirus positive specimens. The results showed no cross reactivity

LIMITATIONS

1. ACCU-TELL^® COVID-19 Antigen Cassette (Nasal Swab) is for use only by individuals who have been given appropriate training for in vitro diagnostic use. Neither the quantitative value nor the rate of increase in SARS-CoV-2 virus concentration can be determined by this qualitative test.

2. The accuracy of the test depends on the quality of the swab sample. False negatives may result from improper sample collection or storage.

3. ACCU-TELL^® COVID-19 Antigen Cassette (Nasal Swab) will only indicate the presence of SARS-CoV-2 in the specimen from both viable and non-viable SARS-CoV-2 coronavirus strains.

4. As with all diagnostic tests, all results must be interpreted together with other clinical information available to the physician.

5. A negative result obtained from this kit should be confirmed by PCR, and/or should be interpreted and followed up in line with national/regional guidance. A negative result may be obtained if the concentration of the SARS-CoV-2 virus present in the swab is not adequate or is below the detectable level of the test.

6. Excess blood or mucus on the swab specimen may interfere with test performance and may yield a false positive result.

7. A positive result for SARS-CoV-2 does not preclude an underlying co-infection with another pathogen, therefore the possibility of an underlying bacterial infection should be considered.

8. Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals

9. Positive results may be due to current infection with acute non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43 or 229E, SARS-CoV-1.

10. Results from antigen testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.

11. Exaction buffer has the ability to kill the virus, but it cannot inactivate 100% of the virus. The method of inactivating the virus can be referred to: what method is recommended by WHO/CDC, or it can be handled according to local regulations.

Note: The above information is for reference use only. Please refer to the product insert provided with the products before use.