Accu-Tell^® SARS-CoV-2+Flu A&B Antigen Combo Cassette

Product Description

STATEMENT:

1. Accu-Tell^® SARS-CoV-2+Flu A&B Antigen Combo 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+Flu A&B Antigen Combo Cassette without FDA clearance in USA.

CATALOG

KEY POINTS

Detection for:  SARS-CoV-2, Influenza A&B Antigen in Nasopharyngeal swab. For professional in vitro diagnostic use only.

Reading time: at 10 minutes

Detection Limit of SARS-CoV-2：The Estimated LOD is 1000 TCID ₅₀/mL.

INTENDED USE

ACCU-TELL^® SARS-CoV-2+Flu A&B Antigen Combo Cassette (Nasopharyngeal Swab) is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2, Influenza A&B Antigen in Nasopharyngeal swab. It is intended to aid in the rapid differential diagnosis of COVID-19, Influenza A and B infections.

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+Flu A&B Antigen Combo 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+Flu A&B Antigen Combo Cassette (Nasopharyngeal Swab). Specimens were considered positive if PCR indicated a positive result.

Detection Limit of SARS-CoV-2 The LOD for the SARS-CoV-2 Antigen Test was established using limiting dilutions of a viral sample inactivated. The material (ZeptoMetrix, 0810587CFHI) was supplied at a concentration of 1.15x10⁷TCID₅₀/mL. The Estimated LOD is 1000 TCID ₅₀/mL.

Reactivity with Human Influenza Strain

Influenza A strains

Subtype of H1N1: Mal/302/54, New Jersey/8/76, NWS/33, WS/33, Guangdong-Maonan/SWL1536/2019; H3N2: Aichi/2/68, Hong Kong/8/68, Port Chalmers/1/73, Hong Kong/2671/2019; H7N9 Anhui/1/2013, all are positive.

Influenza B strains

Russia/69, Hong Kong/5/72, Lee/40, Brigit, R5, Wisconsin/1/2010, Florida/78/2015, Phuket/3073/2013, Washington/02/2019, all are positive.

Cross Reactivity

ACCU-TELL^® SARS-CoV-2+Flu A&B Antigen Combo Cassette (Nasopharyngeal Swab) For SARS-CoV-2 Antigen Test 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, MERS-coronavirus positive specimens. The results showed no cross reactivity. ACCU-TELL^® SARS-CoV-2+Flu A&B Antigen Combo Cassette (Nasopharyngeal Swab) For FLU A&B Antigen Test has been tested for Adenovirus, Coxsackie virus, Cytomegalovirus, Parainfluenza Virus Type1,2,3,4a, Enterovirus, Mumps virus, Respiratory syncytial virus, Rhinovirus, Bordetella pertussis, Haemophilusparainfluenzae, Staphylococcus aureus, Streptococcus agalactiae, Neisseria meningitides, Streptococcus sp. group A, B, C. The results showed no cross reactivity.

LIMITATIONS

1. ACCU-TELL^® SARS-CoV-2+Flu A&B Antigen Combo Cassette (Nasopharyngeal Swab) is for professional in vitro diagnostic use only. The test should be used for the detection of SARS-CoV-2, Influenza A&B Antigen in Nasopharyngeal swab. Neither the quantitative value nor the rate of increase in SARS-CoV-2 virus, Influenza A&B 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+Flu A&B Antigen Combo Cassette (Nasopharyngeal Swab) will only indicate the presence of SARS-CoV-2, Influenza A&B in the specimen from both viable and non-viable SARS-CoV-2 coronavirus, Influenza A and B 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, Influenza A&B 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. Positive result for SARS-CoV-2, Influenza A and/or B do 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, Influenza A and/or B 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. The use of over-the-counter and prescription nasal sprays at high concentrations can interfere with results, leading to either invalid or incorrect test results.

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

11. Results from antigen testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2, Influenza A &B infection or to inform infection status.

12. Extraction reagent 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.