【藥品名稱】：通用名稱：
英文名稱：Diagnostic Kit for Hepatitis B Surface Antigen
漢語拼音：YiXing GanYan BingDu BiaoMian KangYuan ZhenDuan ShiJiHe（MeiLianMianYiFa）
【預期用途】：用于乙型肝炎病毒表面抗原的檢測。
【檢驗原理】：本試劑盒系由抗-HBs包被的微孔酶聯板和HRP標記的抗-HBs及其它試劑配套組成，采用雙抗體夾心法原理檢測乙型肝炎病毒表面抗原（HBsAg）。
【組成成份】：規格                   48人份                           96人份
1.     酶聯板         48孔                    96孔
2.     陰性對照      0.5ml ×1       0.5 ml ×1
3.     陽性對照      0.5ml ×1       0.5 ml ×1
4.     酶結合物       3 ml ×1            6 ml ×1
5.     顯色劑A                    3 ml ×1         6 ml ×1
6.     顯色劑B              3 ml ×1         6 ml ×1
7.     20倍洗滌液                 20 ml ×1        40 ml ×1
8.     終止液       3 ml ×1          6 ml ×1
9.     說明書       1份         1份
10.     不干膠條       2張        2張
11.     自封塑料袋       1個        1個
【適用儀器】：
1. 酶標儀。
2. 全自動酶免檢測系統、或洗板機、或手工洗液瓶。
【檢驗方法】：
1. 稀釋：將20倍濃縮洗滌液用蒸餾水稀釋20倍后備用。
2. 加樣及酶：按待測樣品的數取一定量的預包被酶聯板。每次實驗設空白對照1孔，陰、陽性對照各2孔。在各孔依次加入待檢標本及陰、陽性對照50µl，然后每孔各加酶結合物50µl（1滴）（空白對照孔不加），混勻，貼上不干膠條，置37℃溫育60分鐘。
3. 洗板：棄去反應孔內液體，將20倍洗滌液用蒸餾水稀釋20倍后注滿各孔，靜置10-20秒，甩掉洗滌液。重復洗板共5次，zui后拍干。
4. 顯色：依次在每孔加顯色劑A液、B液各50µl（1滴），混勻，置37℃避光溫育15分鐘。
5. 終止：依次在每孔加終止液50µl（1滴），混勻。
6. 測定：用酶標儀對空白孔調零，單波長450nm或雙波長450nm/620-690nm讀取各孔的OD值。
【檢驗結果的解釋】：
1. 臨界值（cutoff值）計算：
臨界值（cutoff值）= 陰性對照平均OD值×2.1
注：陰性對照平均OD值低于0.05時，按0.05計算，高于0.05按實際計算。
2. 待檢樣品OD值≥臨界值（cutoff值）者，為HBsAg陽性；
待檢樣品OD值<臨界值（cutoff值）者，為HBsAg陰性。
【注意事項】：
1. 試劑盒從冷藏環境中取出，應平衡至室溫后再使用。
2. 檢測必須符合國家有關HBV檢測的實驗室管理及安全的規定，并按有關實驗室規程處理所使用組份及樣品。試劑盒組份內不同程度地含有對人體有害的試劑，注意不要將這些組份濺到眼睛、皮膚或衣服上，一旦發生，應立即用足量的水清洗受害部位。
3. 嚴格控制反應溫度和時間，并盡量使用移液器加樣，結果判定以酶標儀讀數為準。
【貯存條件】：2-8℃       【有效期】：12個月

[Name of drug]: generic name: hepatitis B virus surface antigen diagnostic kit
English name: Diagnostic Kit for Hepatitis B Surface Antigen
Chinese Pinyin: YiXing GanYan BingDu BiaoMian KangYuan ZhenDuan ShiJiHe (MeiLianMianYiFa)
[Intended use]: for the detection of hepatitis B virus surface antigen.
【Test principle】: The kit is composed of anti-HBs coated microporous enzyme plate and HRP labeled anti-HBs and other reagents supporting the use of double antibody sandwich method to detect hepatitis B virus surface antigen (HBsAg) The
【Composition】: Specifications 48 copies of 96 copies of copies
1. Enzyme plate 48 wells 96 wells
2. Negative control 0.5ml × 1 0.5 ml × 1
3. Positive control 0.5ml × 1 0.5 ml × 1
4. Enzyme conjugate 3 ml × 1 6 ml × 1
5. Reagent A 3 ml × 1 6 ml × 1
6. Reagent B 3 ml × 1 6 ml × 1
7. 20 times washing liquid 20 ml × 1 40 ml × 1
8. Stop solution 3 ml × 1 6 ml × 1
9. 1 copy of the instructions
10 stickers 2 sheets 2 sheets
11. Self-styled plastic bag 1 one
【Apparatus】:
1. Microplate reader
2. Automatic enzyme-free detection system, or washing machine, or manual lotion bottle.
【Testing method】:
1. Dilution: 20 times the concentration of washing liquid diluted with distilled water 20 times standby.
2. Add sample and enzyme: according to the number of samples to be taken a certain amount of pre-coated enzyme plate. Each experiment set a blank control 1 hole, negative, positive control of the 2 holes. (1 drop) (blank control hole not added), mix, paste the stickers, set 37 ℃ temperature For 60 minutes.
3. Wash plate: discard the liquid in the reaction hole, 20 times the washing liquid diluted with distilled water 20 times after filling the hole, put it aside for 10-20 seconds, get rid of the washing liquid. Repeat the wash plate a total of 5 times, and finally pat dry.
4. Color: in each hole plus reagent A liquid, B liquid 50μl (1 drop), mix, set 37 ℃ underwent incubation for 15 minutes.
5. Termination: followed by adding 50μl (1 drop) of stop solution in each well and mixing.
6. Determination: with a microplate reader on the blank hole zero, single wavelength 450nm or dual wavelength 450nm / 620-690nm read the hole OD value.
[Explanation of test results]:
1. critical value (cutoff value) calculation:
Threshold value (cutoff value) = negative control average OD value × 2.1
Note: Negative control of the average OD value of less than 0.05, calculated by 0.05, higher than 0.05 according to the actual calculation.
2. Check the sample OD value ≥ critical value (cutoff value), HBsAg positive;
Check the sample OD value <critical value (cutoff value), HBsAg negative.
【Precautions】:
1. Remove the kit from the refrigerated environment and be allowed to stand at room temperature before use.
2. The test must comply with the national regulations on laboratory management and safety of HBV testing and treat the components and samples used in accordance with the relevant laboratory procedures. Reagent components to the extent of the body contains harmful reagents, careful not to splash these components on the eyes, skin or clothes, in the event, should immediay wash the affected parts with plenty of water.
3. Strict control of reaction temperature and time, and try to use the pipette sample, the results determined to microplate reader readings prevail.
【Storage conditions】: 2-8 ℃ 【Validity】: 12 months

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【公司名稱】廣州健侖生物科技有限公司
【市場部】楊永漢

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