Accu-Tell^® COVID-19 Antigen Cassette (Saliva)

Product Description

STATEMENT:

1. Accu-Tell^® COVID-19 Antigen Cassette (Saliva) 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 (Saliva) without FDA clearance in USA.

CATALOG

KEY POINTS

Detection for: qualitative detection of COVID-19 antigen in Saliva. The identification is based on the monoclonal  antibodies specific for the Nucleocapsid（N）protein of  SARS-CoV-2.. For professional in vitro diagnostic use only.

Reading time: at 10 minutes

Relative Sensitivity: 95.0% (95%CI*:83.1%-98.4%)*

Relative Specificity: ＞99.9% (95%CI*:99.1%-100.0%)*

Relative accuracy: 99.5% (95%CI*:98.0%-99.9%)*

* Confidence Intervals

Detection Limit: 1000 TCID₅₀/mL.

INTENDED USE

ACCU-TELL^® COVID-19 Antigen Cassette (Saliva) is a rapid chromatographic immunoassay for the qualitative detection of COVID-19 antigen in Saliva. 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.

MATERIALS

Materials provided

Materials required but not provided

Timer                                   

SPECIMEN COLLECTION AND PREPARATION

ACCU-TELL^® COVID-19 Antigen Cassette (Saliva) performed using Saliva specimens. The quality of specimens obtained is of extreme importance. Detection of COVID-19 Antigen requires a vigorous and thorough collection technique that provides COVID-19 Antigen rather than just body fluids. It is recommended to use Early-morning posterior oropharyngeal spitting or drooling.

To collect Saliva Specimen:

Use the collection tube to collect saliva, install saliva collector, and collect Saliva specimen as follows:

Important: Before collecting saliva relax your cheeks and gently massage cheeks with fingers for 15-30 seconds, Place the tongue against the upper  and lower jaws and  roots to enrich the saliva.

Put the collection tube with saliva collector close to lips, gently spit saliva into.

Lightly flick up and down or shake the collection tube with saliva collector, let the saliva flow into the collection  tube.  The  volume  of  saliva  needs  to  be  between  two  scale marks(approx. 150-300μl).Then discard the used Saliva collector.

If the volume of saliva is too much, use a dropper or pipette to remove the excess saliva until the final solution is between the two scales marks (approx. 150-300μl).

- For best performance, direct Saliva specimens should be tested as soon as possible after collection. If immediate testing is not possible:

- The Saliva specimen can be stored at room temperature in an airtight container for not more than 2 hours.

- The extracted Saliva sample in the extraction tube can be stored at room temperature for 2 hours or at 2-8°C for 2 hours.

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. Extract the COVID-19 antigen according to the specimen type.

For Saliva Specimen:

Place the collection tube which contains the saliva in the workstation. Twist the top off the extraction reagent bottle taking care not to squeeze the middle area containing liquid. Hold the extraction reagent bottle upside down vertically and squeeze the bottle to let the solution drop into the extraction tube freely without touching the edge of the tube. Add all of the extraction buffer (Approx. 300μL) to the collection tube.

3. Lid the cap onto the specimen collection tube. Shake the specimen collection tube  more than three times vigorously to mix the saliva and the extraction buffer, then squeeze the mixed solution ten times to allow the saliva to be thoroughly mixed.

4. Place the test cassette on a clean and level surface. Invert the specimen collection tube and transfer 3 full drops of the extracted specimen (approximately 80μL) to the specimen well (S) of the test cassette, then start the timer. Avoid trapping air bubbles in the specimen well (S). Read the result at 10 minutes. Do not interpret the result after 20 minutes.

PERFORMANCE CHARACTERISTICS

Sensitivity, Specificity and Accuracy

ACCU-TELL^® COVID-19 Antigen Cassette (Saliva) has been evaluated with specimens obtained from the patients. RT-PCR is used as the reference method for ACCU-TELL^® COVID-19 Antigen Cassette (Saliva). Specimens were considered positive if PCR indicated a positive result.

Relative Sensitivity: 95.0% (95%CI*:83.1%-98.4%)*

Relative Specificity: ＞99.9% (95%CI*:99.1%-100.0%)*

Relative accuracy: 99.5% (95%CI*:98.0%-99.9%)*

* Confidence Intervals

Detection Limit

The LOD for ACCU-TELL® COVID-19 Antigen Cassette (Saliva) 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 (Saliva) 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

LIMITATIONS

1. ACCU-TELL^® COVID-19 Antigen Cassette (Saliva) is for professional in vitro diagnostic use only. The test should be used for the detection of COVID-19 Antigen in Saliva. 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 saliva sample. False negatives may result from improper sample collection or storage.

3. ACCU-TELL^® COVID-19 Antigen Cassette (Saliva) 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 saliva is not adequate or is below the detectable level of the test.

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

7. A positive result for COVID-19 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

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. 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.

Product Video

1. Accu-Tell^® COVID-19 Antigen Cassette (Saliva)