Product description
Specifications 1. Easy and Convenient to use
2. Competitive price.
3. Creditable performance.
4. OEM available.
INTENDED USE The HBeAg Test Kit is an enzyme-linked immunosorbent assay (ELISA) for teh qualitative determination of Hepatitis B Surface Antigen (HBsAg) in human serum or plasma. CONTENTS OF THE KIT 1. Coated Micro-titer well Plate 96T/12wells 96T/8wells 2. Enzyme Conjugate Concentrate (20x) 7ml 9ml 3. Positive Control 1ml 1ml 4. Negative Control 1ml 1ml 5. Color A (H2O2 Solution) 7ml 14ml 6. Color B (TMB Substrate) 7ml 14ml 7. Stop Solution (2M Sulfuric Acid) 7ml 14ml 8. Wash Buffer Concentrate (20X) 25ml 25ml 9. Plate Sealer 2pcs 2pcs 10. Plastic Bag 1pc 1pc 11. Package insert 1pc 1pc (The above items should be stored at 2~8°c) SPECIMEN COLLECTION AND STORAGE 1. Collect serum or plasma specimens following regular clinical laboratory procedures. Separate the serum from the clot or plasma from the red cells as soon as possible to avoid hemolysis. 2. Specimens containing sodium azide or particulate matter may give erroneous results. 3. Specimens should be refrigerated if not used within 3 days of collecting. Avoid freezing and thawing the specimens more than 2-3 times before using. ASSAY PROCEDURES 1. Bring all reagents and specimens to room temperature (18-25°c) before the assay. Swirl gently before use. Adjust incubator to 37±1°c. 2. Write down the numbers of specimens and the wells on the data sheet. One well for blank, five additional wells for the controls and one well for each specimen. NOTE: Cover the unused wells with plate sealer, seal in the plastics bag with desiccant, and store at 2~8°c. 3. Add 50ul of control (3 negative controls and 2 positive controls) and 50ul of each specimen into wells respectively (Reserve 2well for blank) 4. Add 50ul enzyme conjugate working solution into each reaction well except for the blank. NOTE: Do not touch the edge of wells to avoid false reults. 5. Gently tap the plate to thoroughly mix the liquid in the wells; do not splash liquid onto the slip. 6. Incubate the plate in a 37°c for 60 minutes in an incubator. Balance the plate in room temperature for 5 minutes. 7. Wash each well five times with wash buffer: a. Washing must be performed strictly according to the instructions; incomplete washing may bring out the false result. b. Aspirate the well contents completely into a waste flask. Then fill up the wells with wash buffer (350ul or more), avoid overflow. Allow to soak (approx. 30-60 seconds). Aspirate completely and repeat the wash and soak procedure four additional times for a total of five washes. c. Make sure that no fluid remains on the strip-holder and strips after the last aspiration (e.g., by blotting with absorbent tissue.) NOTE: improper washing may cause false result. 8. Add 50ul color A and 50ul color B to each well. 9. Incubate the plate in a 37°c incubator for 15 minutes. 10. Add 50ul 2M sulfuric acid into each well, gently tap the plate. 11. Measure OD with Micro-well reader at 450nm (single wavelength) or 450nm and 630nm as reference (dual wavelength). CALCULATIONS AND RESULT 1. Negative Control Mean absorbance (NCx): NCx = (NC1+NC2+NC3)/3 Eliminate any NC greater than 0.2 2. Cut-off value: Cut-off=2.1 X NCx Any NCx less than 0.05 should be regarded as 0.05. 3. Divide the sample absorbance by the cut-off value Positive: sample absorbance is greater tahn or equal (≥) to Cut-off value Negative: sample absorbance is less than (<) cut-off value. ANALYTICALSENSITIVITY (LIMIT DETECTABILITY) 2 NCU/ml INTERPRETATION OF RESULTS Repeat testing in duplicate of a specimen found reactive by the screening procedure will verify whether it is repeatably reactive. If neither of the repeat tests is reactive, the specimen should be considered negative. If the specimen is reactive in either of the repeat tests, the sample should be considered repeat ably reactive and tested by a confirmatory test. False reactive results may be caused by one of the following technical problems: a. Carryover of a highly reactive sample due to contamination with of equipment or pipette tips. b. Substrate contamination with metal ions. c. Cross-contamination. d. Inadequate wash or aspirations during wash procedure. e. Failure to remove excess moisture from the bottom of the well. ABOUT US we have exported our in vitro rapid diagnostic test and lab equipment to over 50 countries. Our Aim: ——Let every family benefit from our convenient and reliable diagnostic products and services. ——Let our lab equipment be used in every laboratory of the world. Our Values on Quality: ——Delivers customer value in all in all projects, services and processes; ——Gives quality at least as much consideration as schedules and budgets when day-to-day choices need to be made; ——Drives QMS results to the bottom line in terms of defect reduction and financial benefits; ——Allocates resources to achieve quality execution. Our product have got ISO13485 & ISO9001 certification.
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