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The 1/2 Rapid Test Device (Serum/Plasma) is a rapid visual immunoassay for the qualitative presumptive detection of antibodies to in serum or plasma specimens. This kit is intended to be used as an aid in the diagnosis of infection.KIT COMPONENTS Individually packed test devices Each device contains a strip with coloreconjugates and reactive reagents pre-spreaded the corresponding regions. Disposable pipettes For adding specimens use. Buffer 2mL/vial. Phosphate buffered saline anpreservative. Package insert For operation instruction. MATERIALS REQUIRED BUT NOT PROVIDED Specimen collection container For specimens collection use. Timer For timing use. Centrifuge For preparation of clear specimens STORAGE AND STABILITY 1.The kit should be stored at 2-30°C until the expiry date printed on the sealed pouch. 2.The test must remain in the sealed pouch until use. 3.Do not freeze. 4.Cares should be taken to protect components in this kit from contamination. Do not use if there is evidence of microbial contamination or precipitation. Biological contamination of dispensing equipments, containers or reagents can lead to false results. SPECIMEN COLLECTION AND STORAGE 1.The 1/2 Rapid Test Device (Serum/Plasma) is intended only for use with human serum, or plasma specimens. 2. Only clear, non-hemolyzed specimens are recommended for use with this test. Serum or plasma should be separated with soonest possible opportunity to avoid hemolysis. 3.Perform the testing immediately after the specimen collection. Do not leave the specimens at room temperature for prolonged periods. Specimens may be stored at 2-8°C for up to 3 days. For long term storage, specimens should be kept below -20°C. 4. Bring specimens to room temperature prior to testing. Frozen specimens must be completely thawed and mixed well prior to testing. Avoid repeated freezing and thawing of specimens. 5. Pack the specimens in compliance with applicable regulations for transportation of etiological agents, in case they need to be shipped. 6. Icteric, lipemic, hemolysed, heat treated and contaminated sera may cause erroneous results.