Accu-Tell^® SARS-CoV-2 Neutralizing Antibody Cassette (RBD) (Whole Blood/Serum/Plasma)

Product Description

STATEMENT:

1. Accu-Tell^® SARS-CoV-2 Neutralizing Antibody Cassette （RBD）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 Neutralizing Antibody Cassette (RBD) without FDA clearance in USA.

CATALOG

KEY POINTS

Detection for: Qualitative detection of neutralizing antibodies to SARS-CoV-2 in whole blood, serum, or plasma.  For professional in vitro diagnostic use only.

Reading time: at 15 minutes

Relative Sensitivity: 98.0% (95%*CI: 89.4%~99.9%);

Relative Specificity: 100.0% (95%*CI: 94.2%~100.0%);

Accuracy: 99.0% (95%*CI: 94.6%~100.0%);

*CI means confidence interval.

INTENDED USE

ACCU-TELL^® SARS-CoV-2 Neutralizing Antibody Cassette (RBD) (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of neutralizing antibodies to SARS-CoV-2 in human whole blood, serum, or plasma as an aid in the diagnosis of the presence of neutralizing antibodies to SARS-CoV-2

For professional in vitro diagnostic use only.

PRINCIPLE

ACCU-TELL^® SARS-CoV-2 Neutralizing Antibody Cassette (RBD) (Whole Blood/Serum/Plasma) is a qualitative membrane based immunoassay for the detection of neutralizing antibodies to SARS-CoV-2 in whole blood, serum or plasma. The membrane is pre-coated with Angiotensin I Converting Enzyme 2 (ACE2) on the test line region of the strip. During testing, the whole blood, serum or plasma specimen reacts with S-RBD conjugated colloid gold. The mixture migrates upward on the membrane chromatographically by capillary action to react with ACE2 on the membrane and generate a colored line. Presence of this colored line and the color  line indicates a negative result, while its absence indicates a positive result. To serve as a  procedural control, a colored line will always change from Blue to Red in the control line region, indicating that the proper volume of specimen has been added and membrane wicking has occurred.

Materials

Test cassettes  

Droppers or capillaries

Buffer       

Package insert

Materials required but not provided

Specimen collection containers

Centrifuge (for plasma only)

Micropipette     

Timer

Lancets (for fingerstick whole blood only)

 TEST PROCEDURE

Allow the test cassette, specimen, buffer, and/or controls to reach room temperature (15-30°C) prior to testing.

1. Bring the pouch to room temperature before opening. Remove the test cassette from the sealed pouch and use it within one hour.

2. Place the test cassette on a clean and level surface.

For Serum or Plasma:

Hold the dropper vertically and transfer 1 drop of serum/plasma (approximately 25µl) to the specimen well (S) of the test cassette, then add 2 drops of buffer (approximately 80µl) and start the timer. Avoid trapping air bubbles in the specimen well.

For Whole Blood Specimens:

Hold the dropper vertically and transfer 2 drops of whole blood (approximately 50µl) to the specimen well (S) of the test cassette, then add 2 drops of buffer (approximately 80µl) and start the timer. Avoid trapping air bubbles in the specimen well.

3. Wait for the colored line(s) to appear. The test result should be read at 15 minutes. Do not interpret the result after 20 minutes.

RESULT INTERPRETATION

(Please refer to the illustration above)

POSITIVE: The colored line in the control line region (C) changes from Blue to Red and one colored line appears in the reference line region (R). The intensity of colored line in test line region (T) is weaker than or closes to the reference line in the reference region (R).

NOTE: The intensity of the color in the test line region will vary depending on the concentration of neutralizing antibodies to SARS-CoV-2 in the specimen.

NEGATIVE: The colored line in the control line region (C) changes from Blue to Red and one colored line appear in the reference line region (R). The intensity of colored line in test line region(T) is stronger than the reference line in the reference region (R).

INVALID: Control line (C) is still completely or partially blue, and fails to completely change from Blue to Red and/or part of reference line or no reference line appears. Insufficient buffer volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the procedure with a new test cassette. If the problem persists, discontinue using the test kit immediately and contact your local distributor.

PERFORMANCE CHARACTERISTICS

Generally, the higher the titer of neutralizing antibody is, the better the individual protection is. Microneutralization Assay (MNA50) is an established method of assessing the humoral response. Positive results obtained with 1:10 dilution in MNA50 assay indicates that the individuals are already protected and the same with 1:20 dilution indicates that the individuals have strong protection. Therefore, MNA50 assay at 1:10 dilution was selected as the comparison method to evaluate the efficacy of ACCU-TELL^® SARS-CoV-2 Neutralizing Antibody Cassette (RBD) (Whole Blood/Serum/Plasma).

1st The cutoff of MNA50 is maintained at 1:10 dilution and the clinical characteristics are showed below:

In order to evaluate the clinical performance of ACCU-TELL^® SARS-CoV-2 Neutralizing Antibody Cassette (RBD) (Whole Blood/Serum/Plasma), the comparator Microneutralization Assay (MNA) and SARS-CoV-2 Neutralizing Antibody Elisa Kit were used. The cutoff for the MNA comparator tests was established as indicated below:

Clinical Performance using MNA50 titer as the comparator method

A total of 100 samples including 50 MNA50 positive and 50 MNA50 negative samples were evaluated with the SARS-CoV-2 Neutralizing Antibody rapid test cassette.

Relative Sensitivity: 49/ (1+49) =98.0% (95%*CI: 89.4%~99.9%);

Relative Specificity: 50/ (50+0) =100.0% (95%*CI: 94.2%~100.0%);

Accuracy: (49+50)/ (49+1+0+50) =99.0% (95%*CI: 94.6%~100.0%);

*CI means confidence interval.

2nd The cutoff of MNA50 is maintained at 1:20 (dilution titer) and the clinical characteristics are showed below:

In order to evaluate the clinical performance of ACCU-TELL^® SARS-CoV-2 Neutralizing Antibody Cassette (RBD) (Whole Blood/Serum/Plasma), the comparator Microneutralization Assay (MNA) and SARS-CoV-2 Neutralizing Antibody Elisa Kit were used. The cutoff for the MNA comparator tests was established as indicated below:

Clinical Performance using MNA50 titer as the comparator method

A total of 100 samples including 50 MNA50 positive and 50 MNA50 negative samples were evaluated with the SARS-CoV-2 Neutralizing Antibody rapid test cassette.

Relative Sensitivity: 49/ (1+49) =98.0% (95%*CI: 89.4%~99.9%);

Relative Specificity: 50/ (50+0) =100.0% (95%*CI: 94.2%~100.0%);

Accuracy: (49+50)/ (49+1+0+50) =99.0% (95%*CI: 94.6%~100.0%);

*CI means confidence interval.

3rd Clinical Performance using Elisa kit as the comparator method with samples from vaccinated individuals, or healthy unvaccinated individual

A total of 60 samples were collected from vaccinated individuals(Inactivated SARS-CoV-2 Vaccine), or healthy unvaccinated individuals (30 Elisa positive and 30 Elisa negative) and were evaluated with ACCU-TELL^® SARS-CoV-2 Neutralizing Antibody Cassette (RBD) (Whole Blood/Serum/Plasma).

Relative Sensitivity: 30/ (0+30) =100.0% (95%*CI: 90.5%~100.0%);

Relative Specificity: 30/ (30+0) =100.0% (95%*CI: 90.5%~100.0%);

Accuracy: (30+30)/ (30+0+0+30) =100.0% (95%*CI: 95.1%~100.0%);

*CI means confidence interval.

Cross-reactivity

ACCU-TELL^® SARS-CoV-2 Neutralizing Antibody Cassette (RBD) (Whole Blood/Serum/Plasma) has been tested for anti-influenza A virus, anti-influenza B virus, anti-RSV, anti-Adenovirus, HBsAg, anti-Syphilis, anti-H. Pylori, anti-HIV, anti-HCV, anti-haemophilus influenza, ANA, coronavirus HKU1, NL63, OC43, 229E, MERS-CoV Rheumatoid Factor, Anti-SARS-CoV, Anti-MERS-CoV and HAMA positive specimens. The results showed no cross-reactivity. Some cross reactivity was observed with samples positive for SARS-CoV rabbit antibody. Cross reactivity could be observed with the high titer Rheumatoid Factor.

Interfering Substances

The following potentially interfering substances were added to SARS-CoV-2 neutralizing antibody negative and spiked positive specimens.

None of the substances at the concentration tested interfered in the assay.

LIMITATIONS

1. ACCU-TELL^® SARS-CoV-2 Neutralizing Antibody Cassette (RBD) (Whole Blood/Serum/Plasma) is for in vitro diagnostic use only. The test should be used for the detection of neutralizing antibodies to SARS-CoV-2 in whole blood, serum or plasma specimens only.

2. The best time to detect the presence of neutralizing antibodies is 15 days from the second vaccination day (COVID-19 Vaccination are given on two days usually with a gap of 28 days.

- Here the number of days to be calculated from the second vaccination day) in case of mRNA vaccines.

3. Results from ACCU-TELL^® SARS-CoV-2 Neutralizing Antibody Cassette (RBD) (Whole Blood/Serum/Plasma) should not be used as the sole basis to diagnose or exclude the presence of neutralizing antibodies to SARS-CoV-2.

4. The continued presence or absence of neutralizing antibodies cannot be used to determine the success or failure of the vaccine.

5. Results from immunosuppressed patients should be interpreted with caution.

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

7. Not for the screening of donated blood.

8. This test has not been reviewed by the FDA.

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