Product Name: Runkun Medical Rapid Detection Test on Stock Model NO.: IgM / IgG Certification: CE, FDA, ISO13485 Material: Plastic Application: Clinical Trademark: RUNKUN Transport Package: Carton Origin: China Product Description IgM/IgG Test Kit(Colloidal Gold)ComponentsComponentsSpecification 20 tests/kit40 tests/kitTest Card :• Mouse anti-human IgM antibody, mouse anti-human IgG antibody and rabbit IgG antibody fixed on the nitrocellulose membrane• Colloidal gold-labeled recombinant antigen and goat anti-rabbit IgG antibody fixed on glass fiber conjugate pad• Absorbent paper• PVC board• Plastic clip• Desiccant 20 test cards 40 test cardsSpecimen Diluent(0.9%NaCl solution)1 bottle(5ml)1 bottle(5ml)Note: :The components in different batches cannot be used interchangeably.Storage ConditionsThe kit should be stored at 2ºC~30ºC,sealed,avoid direct sunlight and the validity period is 18 months.The test card should be used within 1 hour after taking out from the foil pouch.Specimen diluent should be used within 14 days after opened and stored at 2ºC~30ºC.Requirements of SpecimenIt is suit to test the type of specimen human serum, plasma, and whole blood.The specimen of whole blood can be prepared by anticoagulants as follow: EDTA, heparin, sodium citrate.The serum and plasma can be stored at 2ºC~8ºCfor 7 days, -20ºC±5ºC for 1 year, and Freeze-thaw less than 3 times if store in -20ºC±5ºC.The anticoagulated whole blood should be store it in 2ºC~8ºC for less than 2 days.The specimen should be slowly returned to room temperature and mixed before testing if it store in low temperature.Test ProcedurePlease read the protocols carefully before testing.Do not open sealed foil pouch before using.1.The kit does not need to be installed. Before use, check the Test Card to insure the foil pouch is undamaged and the Specimen Diluent is no leakage.2. Bring the Test Card and the Specimen Diluent to room temperature before testing,The Test Card should be used in 1 hour after remove from foil pouch3.Take10μL of serum or plasma or whole blood specimen to the specimen well of Test Card and then add 2 drops (80 μL) of Specimen Diluent to the specimen well, avoid air bubbles.4.Wait for 10 minutes, and read the results by viewing the detection window. Please read results in 15min.5. All wastes should be treated as potential infectious materials.Result InterpretationNegative ResultIf only the quality control line (C) is red, but the detection lines of G and M are not visible, then no antibody has been detected and the result is negative.Positive Result, M onlyIf both the quality control line (C) and the detection line of M are red, then IgM antibody has been detected and the result is positive for the IgM antibody.Positive Result, G onlyIf both the quality control line (C) and the detection line of G are red, then IgG antibody has been detected and the result is positive for the IgG antibody.Positive Result, G and MIf the quality control line (C) and the two detection lines of G and M are red, then IgG and IgM antibodies have been detected and the result is positive for both the IgG and IgM antibodies.Invalid results:If the control line is not red, the test is invalid. The operation may not have been followed correctly or the kit may have deteriorated. It is recommended that the specimen be re-tested.Quality Control and Validity of ResultsThe whole workflow and the quality of kit is control by quality control line (C).1. If the quality control line (C) is red in test, it illustrate that the whole workflow and the quality of kit are qualified.2. If the quality control line (C) is not red in test, no matter what the detection line display, it illustrate that the operation may not have been followed correctly or the kit may has deteriorated. It is recommended that the specimen be re-tested.