[XG002]COVID-19 Neutralizing Ab Test

PRODUCT DETAIL

SPECIMEN PREPARATION

1. The specimen is human serum/plasma and whole blood,including clinical anticoagulants (EDTA, heparin, sodiumcitrate) origin prepared serum or whole blood.

2. Do the test immediately after specimen collection. The speci men could be stored at 2 to 8℃ up to 5 days if testing can, t be done after specimen collection. The specimens should be frozen at -20℃ for longer storage. Avoid multiple freeze-thaw cycles. Anticoagulant whole blood specimen, do not store longer than 72 hours at room temperature and not longer than 7 days at 2 to 8℃.

3. Bring the specimen and test components to room tempera ture if refrigerated or frozen. Mix the specimen well prior to assay once thawed. The precipitate should be removed by centrifugation prior to the test if clearly visible particles existed in the specimen.

4. Do not do the test if specimen including massive lipid, hemolysis or turbidity against invalid test result.

TEST PROCEDURE

Read the instruction first prior to testing. Bring the pouched test to room temperatureprior to testing. Do not open the pouch until ready to begin testing.

1. Remove the test from the sealed pouch. Lay it on a flat, clean and dry surface.

2. Using the provided pipette, add 1 drop specimen to the sample well.

3. Hold the buffer bottle vertically and add 2 drops (approximate 80μl -100μl）of buffer to sample well.

4. Read results within 10-15 minutes.

INTERPRETATION OF RESULTS

Positive: Control（C）line and test（T）line appear in the show window.

Negative: Only one line appears in control（C）area, no line appears in test （T） area.

Invalid: If no line appears in the control （C） area, the test results are invalid regardless of the presence or absence of line in the test（T）area. The direction may not been followed correctly or the test may be deteriorated. It is recommended that repeat the test using a new device. If the problem persist, please stop to use the product and contact local distributor.

STORAGE AND STABILITY

Storage: store at 2~30℃. Shelf life: 24 months.

PERFORMANCE CHARACTERISTICS

1. Analytic Specificity

Results demonstrated that Coretests® COVID-19 Neutralizing Ab Test has no significant cross-reactivity with the seromarkers listed following: Influenza A virus, Influenza B virus, Hepatitis B surface antibody, Hepatitis C virus, Parainfluenza virus, Human immunodeficiency virus, Adenovirus, Respiratory syncytial virus, EB virus, Mumps virus, Varicella zoster virus, Enterovirus 71,Measles virus, Cytomegalovirus, Chlamydia pneumoniae, Mycoplasma pneumoniae, Treponema pallidum.

2. Interference

The following substances and conditions were found not to interfere with the test. List of potentially interfering compounds and concentrations tested are as follows:

3.DIAGNOSTIC SENSITIVITY AND SPECIFICITY

A clinical study using a total 703 blood samples was conducted.The results of the COVID-19 Neutralizing Ab Test were compared with cPass SARS-CoV-2 Neutralization Antibody Detection kit.The diagnostic sensitivity and specificity of the test results are given as below:

Table 1 - Comparison of COVID-19 Neutralizing Ab Test Device

Results gave sensitivity is 99.2% (248/250), a specificity is 99.3%(450/453), and a total agreement of 99.3%(698/703).