Accu-Tell^® SARS-CoV-2 Ag Cassette (Nasopharyngeal Swab)

Product Description

STATEMENT:

1. Accu-Tell^® SARS-CoV-2 Ag Cassette 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^® SARS-CoV-2 Ag Cassette without FDA clearance in USA.

CATALOG

KEY POINTS

Detection for: qualitative detection of SARS-CoV-2 antigen in Nasopharyngeal swab. For professional in vitro diagnostic use only.

Reading time: at 10 minutes

Relative Sensitivity: 95.7% (95%CI*:90.3%-98.6%)*

Relative Specificity: 99.2% (95%CI*:97.6%-99.8%)*

Relative accuracy: 98.3% (95%CI*:96.7%-99.3%)*

* Confidence Intervals

INTENDED USE

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

For professional in vitro diagnostic use only.

MATERIALS

Materials provided:

Test cassettes        

Extraction Reagent    

Extraction Tubes    

Dropper tips

Sterile Swabs         

Package Insert      

Workstation

Materials required but not provided:

Timer                                            

TEST PROCEDURE

Allow the test, specimen, 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. Hold the extraction reagent bottle upside down vertically. Squeeze the bottle and let the solution drop into the extraction tube freely without touching the edge of the tube. Add 8 drops of solution (Approx. 300μL) to the Extraction Tube. See illustration 1.

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 2.

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 3.

5. Fit the dropper tip on top of the extraction tube. Place the test cassette on a clean and level surface. See illustration 4

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

ACCU-TELL^® SARS-CoV-2 Ag Cassette (Nasopharyngeal Swab) has been evaluated with specimens obtained from the patients. RT-PCR is used as the reference method for ACCU-TELL^® SARS-CoV-2 Ag Cassette (Nasopharyngeal Swab). Specimens were considered positive if PCR indicated a positive result.

Relative Sensitivity: 95.7% (95%CI*:90.3%-98.6%)*
Relative Specificity: 99.2% (95%CI*:97.6%-99.8%)*
Relative accuracy: 98.3% (95%CI*:96.7%-99.3%)*
* Confidence Intervals

Detection Limit

The LOD for ACCU-TELL^® SARS-CoV-2 Ag Cassette (Nasopharyngeal 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^® SARS-CoV-2 Ag Cassette (Nasopharyngeal 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),Bordetella pertussis, Legionella pneumophila, Mycobacterium tuberculosis, Mycoplasma pneumoniae, Pneumocystis jirovecii(PJP)-S cerevisiae Recombinant, Pseudomonas aeruginosa, Staphylococcus epidermis, Streptococcus pneumoniae, Streptococcus salivarius, Human coronavirus 229E, Human coronavirus OC43, Human coronavirus NL63, MERS-coronavirus positive specimens. The results showed no cross reactivity.

LIMITATIONS

1. ACCU-TELL^® SARS-CoV-2 Ag Cassette (Nasopharyngeal Swab) is for professional in vitro diagnostic use only. The test should be used for the detection of SARS-CoV-2 Antigen in Nasopharyngeal swab. 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^® SARS-CoV-2 Ag Cassette (Nasopharyngeal 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. 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 present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.

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.

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