1) Lot No, expirations: Marked separately 2) Packaging unit: In-house packaging unit 3) Components (Standard for 25 test/box) Optical Q CoV-19 nAb(Cat. No. : OB193-25)1. Intended use Optical Q CoV-19 nAb is an in vitro diagnostic medical device that quantify RBD specializing antibody for SARS-CoV-2 in human blood using immunofluorescence method. It is used to measure level of RBD specializing antibody of SARS-CoV-2 in human blood. SARS-CoV-2 has structural proteins including Spike (S), Nucleocapsid (N), Membrane (M) and Envelope (E). The Spike protein contains Receptor-binding-domain (RBD) which recognizes Angiotensin Converting Enzyme-2 (ACE2) in cell surface. The RBD from S-protein can bind to ACE2 and infect SARS-CoV-2. The specific antibody for RBD can blocks infiltration and replication of the virus and protect it. Through measuring specific antibodies called RBD specializing antibody in human blood, Optical Q CoV-19 nAb can detect RBD specializing antibody in human blood (serum/plasma) with high sensitivity. Optical Q (Optical Q CoV-19 nAb) quantifies RBD specializing antibody for SARS-CoV-2 in human blood by antigen-antibody immunofluorescence analysis. The provided detection buffer contains RBD bound to fluorescent substance. It binds specifically to the RBD specializing antibody of the sample. When you mix detection buffer with sample, it forms a complex with a antigen-antibody reaction between RBD of the detection buffer and RBD specializing antibody of the sample. When this mixture is added to the sample inlet of the cartridge, it flows along the flat surface of the strip. The complex fails to bind with ACE2 which is coated on the nitro-cellulose membrane. Fluorescence conjugated RBD which is failed to bind RBD specializing antibody is accumulated in test line to response for immune with ACE2. If the level of RBD specializing antibody is lower than detectable level in the blood, there will be a small amount of ACE2-RBD complex accumulated on the test line. In the contrast, If the level of RBD specializing antibody is higher than detectable level in the blood, there will be a large amount of ACE2-RBD complex accumulated ACE2-RBD on the test line. The degree to which an immune response has occurred in converted into a fluorescence signal, and the RBD specializing antibodies concentration is calculated using dedicated measuring equipment and specific equation. 1) For professional and in vitro diagnostic use only. 2) Carefully follow the instructions and procedures described in this insert. 3) Avoid direct sunlight. 4) Both the test cartridge and detection buffer should be discarded after single use. They are disposable. Do not reuse. 5) Test performed by using any test component with mismatching lot number or that beyond the expiration date may appear misleading of test results. 6) Since this product is very sensitive to moisture, please open the pouch immediately before use. 7) Do not use if the pouch is damaged or not sealed. 8) Do not use products that have expired. 9) Do not repeatedly freeze and thaw the sample. 10) Place the test cartridge on a flat surface and analyse it. 11) A test cartridge and detection buffer should be used for processing one sample only. 12) When testing different specimens, avoid contamination between specimens and specimens and use a new sampling tool. 13) Used cartridge, sampling tools, samples and detection buffer may contain infectious agents so discard them depending on your local guidelines. 14) SARS-CoV-2 cannot be diagnosed only with this result. Professional must diagnose it using RT-PCR product which is permitted or Emergency Use Authorization and consider clinical symptoms. 15) Negative result cannot be excluded SARS-CoV-2 infection due to false negative result from the situation such as less than limit of detection for antibody of SARS-CoV-2 in the sample or inappropriate sample collection or delivery. 16) It may diagnose negative result, if there is a mutation in the site to which antibody binds in this product. 17) This product is antibody diagnostic kit. It may possibility of low sensitivity in the initial state of SARS-CoV-2 infection as 1) Serum in human blood 2) Plasma in human blood (EDTA, Heparin, Sodium Citrate) A. Specimen should be stored at -20oC until 3 months. B. Frozen specimen should be used only one time after thawed, and it cannot be used by repeated freezing. 1) Check that the lot numbers of the components (test cartridge, detection buffer and RFID-card) of the Optical Q CoV-19 nAb match. 2) Prepare the cartridge and the detection buffer at room temperature 10 min before starting the test. 3) After the test cartridge pouch is opened, the test should be performed immediately.

1) Add 100ul of the specimens using pipette to the detection buffer tube and close the lid and shaking it about 10 times. 2) Remove the cartridge from the provided pouch and prepare it on a flat surface. 3) Drop 100ul from the tube mixed in (1) into the sample inlet of cartridge. 4) Result is read 15 min after the start of the test. 5) The test results are checked using the dedicated equipment Optical Q. 1) Optical Q automatically calculates the test result and displays RBD iv. Between Site & Reader: It was confirmed that there was no difference in performance as a result of repeated tests three...

To indicate the temperature limitations in which the transport package must be kept and handled To indicate the humidity limitations in which the transport package must be kept and handled Caution, consult accompanying documents Contains sufficient for 25 tests 1) Tugba K. Ralph W. and Hakho Lee., Molecular and Immunological Diagnostic Tests of COVID-19: Current Status and Challenges. iScience. 2020 Aug 21;23(8) Address: Chungbuk TP bonbukwan #Rm 405,406,409, 76 Yeongudanji-ro, Ochang-eup, Cheongwon-gu, Cheongju-si, Chungcheongbuk-do, Republic of Korea (28116) Homepage: www.optibio.co.kr E-mail:...