The assaya SN-Ab Dual Antibody Test for COVID-19 is a rapid in vitro immunochromatographic assay intended for the qualitative detection of antibodies from blood from individuals who are suspected of COVID-19. It should not be used to confirmed or rule out acute infection with SARS-CoV-2, and the test result should not be used as the only basis for diagnosis, treatment or patient management decisions since the immune response for SARS-CoV-2 infection has not been fully established.
The assaya SN-Ab Dual Antibody Test for COVID-19 is a rapid immunochromatographic assay that is composed of two test indicators combined. The N indicator utilizes specific N antigen to detect antibodies in human blood specimens from individuals have antibodies from a natural infection. The S indicator utilizes double specific S-RBD antigen to detect antibodies in human blood specimens from individuals who have been vaccinated with a COVID-19 vaccine.
Negative results do not rule out SARS-CoV-2 infection. Therefore, the test result should not be used as the only basis for patient management decisions. Test result must be combined with clinical observations, patient history and epidemiology to make an overall judgment. At present, it is unknown how long the antibodies exists after SARS-CoV-2 infection.
SARS-CoV-2 is positive-sense single-stranded RNA virus with envelope. The virion is approximately 50–200 nanometers in diameter.₁ It has four structural proteins, known as the spike (S), envelope (E), membrane (M), and nucleocapsid (N) proteins.₂ A rapid anti-N IgG test uses a similar approach to detect human IgG antibodies that are reactive to SARS-CoV-2. The spike protein (S) is composed of S1 and S2 subunits, and the S1 subunit contains the receptor-binding domain (RBD), which can bind at a specific location of angiotensin-converting enzyme 2 (ACE2) in the human host. This binding domain can assist the virus to infect specific cell, including epithelial/ endothelial cell of respiratory tract and gastrointestinal tract, monocytes/ macrophages cell of alveolar. This provides crucial information related to whether a patient has been exposed to SARS-CoV-2 naturally or by vaccination, and where they are temporally in the clinical course of the disease.
This product is for professional use only.
Each box contains 50 test kits. Each test kit contains:
Kit does not include a finger prick lancet or blood specimen collection container.
Storage And Disposal
The product should be stored at 15-30℃ , away from direct sunlight. Do not freeze or overheat the test kit or kit reagents. Kit contents are stable until the expiration date printed on the outer box. The indicators must be kept in the foil pouch until use.
Before use, check the expiration date of the packaging. If the kit is past its expiration date, do not use. Confirm that all components needed are in the kit.
Whole blood is collected in anticoagulant tubes by lancet via finger prick.
Whole blood specimens should be tested as soon as possible after collection in standard laboratory. Specimen could be stored at 2-8°C for up to 72 hours, or could also be stored below -20°C for long-term until before used. Specimen should be avoided to repeat freezing and thawing. The frozen specimen should be thawed and mixed well before testing. In addition, inadequate or inappropriate sample collection, storage, and transport may yield false test results. The training in specimen collection is highly recommended because of the importance of specimen quality.
Stand up the Spacket, and tear it open. Be careful not to spill the liquid reagent inside.
Sample 5 uL of blood into the Spacket.
Place the test indicator in the Spacket with the droplets going down. Leave the test indicator in the Spacket for 10 minutes. Use the assaya timerDx to keep track of the test time.
Take out the test indicator and read the result at 10 minutes. Do not read the result after 20 minutes. The test indicator may also be read by the intelligent analyzer eXpress (iaX-2101) after 10 minutes.
Positive Indicator Line Legend
At 10 minutes, the appearance of the Control Line and ANY shade of Test Line (S or N) on the Test Indicators, indicates a positive result for the presence of antibodies for SARS-CoV-2 S and/or N. Positive test results only mean the antibodies for SARS-CoV-2 S-RBD and/or SARS-CoV-2 N exist in the specimen
At 10 minutes, the appearance of only Control Line on both S and N indicators indicates a negative result for the presence of antibodies for SARS-CoV-2 N and SARS-CoV-2 S-RBD.
If at 10 minutes, the Control Line does not appear, even if a Test Line appears in either the S or N indicator, the result is considered invalid. If the test is invalid, a new test should be performed with a new patient sample and a new Test Indicator.
Two internal procedural controls are needed to confirm correct assay procedure and active kit components. One of two is a line appearing in the “Control Line” area in every run of the test to assess validity of the test. Another one is a clear background serving as an internal negative control. The background color should be white and not interfere with the reading of the test result. If the background color interferes with the reading, it is recommended to repeat the test.
Result Interpretation with the iaX-2101
Please refer to the full iaX-2101 Instructions for Use for complete instructions on how to operate the IaX.
Place the test indicator into the iaX-2101, with the barcode pointing in.
GREEN – (NEGATIVE)
YELLOW ! (INVALID)
RED + (POSITIVE)
Warnings & Precautions
Venous blood specimens were collected for testing by medical technologists. A total of 150 blood specimens were collected, including 60 uninfected subjects, 30 infected patients (1-14 days after symptom onset), 30 infected patients (15-21 days after symptom onset), and 30 infected patients (over than 21 days after symptom onset). Product performance tests were conducted and the results are as follows.
In addition, the performance of the assaya SN-Ab Dual Antibody Test for COVID-19 was compared to the results of an FDA Emergency Use Authorized serology test by 346 blood specimens. The test results are as follows.
The performance of the assaya SN-Ab Dual Antibody Test for COVID-19 was not affected by potentially interfering substances. The item and concentration of interfering substances are listed as follows.
The cross-reactivity of the assaya SN-Ab Dual Antibody Test for COVID-19 was performed on 84 blood specimens which had been confirmed containing other high-risk pathogen antibodies by commercial serology test, including Influenza A/B, Adenovirus, Parainfluenza, Respiratory syncytial virus, Rhinovirus, HCoV-OC43, and SARS-CoV-2. Test result are shown in the table below.
Adverse Events Reporting
Use this link to report any adverse events: assaya.com/ae
Catalog Number (REF): AKIT-SN-AB-01
50 pcs per box (Carton of 50 test kits)
In Vitro Diagnostic Medical Device
Consult Package Insert
Do not reuse
Contains sufficient for <n> tests
Do not use if package is damaged and consult Package Insert