乙型肝炎病毒表面抗原诊断试剂盒

乙型肝炎病毒表面抗原诊断试剂盒

广州健仑生物科技有限公司

本公司为大家供应各种进口品牌和国产品牌的乙肝诊断试剂盒，方法学主要有胶体金、ELISA和PCR等。欢迎咨询  杨

乙型肝炎病毒表面抗原诊断试剂盒

【药品名称】： 通用名称：
英文名称：Diagnostic Kit for Hepatitis B Surface Antigen
汉语拼音：YiXing GanYan BingDu BiaoMian KangYuan ZhenDuan ShiJiHe（MeiLianMianYiFa）
【预期用途】：用于乙型肝炎病毒表面抗原的检测。
【检验原理】：本试剂盒系由抗-HBs包被的微孔酶联板和HRP标记的抗-HBs及其它试剂配套组成，采用双抗体夹心法原理检测乙型肝炎病毒表面抗原（HBsAg）。
【组成成份】： 规格                   48人份                           96人份
1.     酶联板         48孔                    96孔
2.     阴性对照      0.5ml ×1       0.5 ml ×1
3.     阳性对照      0.5ml ×1       0.5 ml ×1
4.     酶结合物       3 ml ×1            6 ml ×1
5.     显色剂A                    3 ml ×1         6 ml ×1
6.     显色剂B              3 ml ×1         6 ml ×1
7.     20倍洗涤液                 20 ml ×1        40 ml ×1
8.     终止液       3 ml ×1          6 ml ×1
9.     说明书       1份         1份
10.     不干胶条       2张        2张
11.     自封塑料袋       1个        1个
【适用仪器】：
1. 酶标仪。
2. 全自动酶免检测系统、或洗板机、或手工洗液瓶。
【检验方法】：
1. 稀释：将20倍浓缩洗涤液用蒸馏水稀释20倍后备用。
2. 加样及酶：按待测样品的数取一定量的预包被酶联板。每次实验设空白对照1孔，阴、阳性对照各2孔。在各孔依次加入待检标本及阴、阳性对照50µl，然后每孔各加酶结合物50µl（1滴）（空白对照孔不加），混匀，贴上不干胶条，置37℃温育60分钟。
3. 洗板：弃去反应孔内液体，将20倍洗涤液用蒸馏水稀释20倍后注满各孔，静置10-20秒，甩掉洗涤液。重复洗板共5次，zui后拍干。
4. 显色：依次在每孔加显色剂A液、B液各50µl（1滴），混匀，置37℃避光温育15分钟。
5. 终止：依次在每孔加终止液50µl（1滴），混匀。
6. 测定：用酶标仪对空白孔调零，单波长450nm或双波长450nm/620-690nm读取各孔的OD值。
【检验结果的解释】：
1. 临界值（cutoff值）计算：
临界值（cutoff值）= 阴性对照平均OD值×2.1
注：阴性对照平均OD值低于0.05时，按0.05计算，高于0.05按实际计算。
2. 待检样品OD值≥临界值（cutoff值）者，为HBsAg阳性；
待检样品OD值<临界值（cutoff值）者，为HBsAg阴性。
【注意事项】：
1. 试剂盒从冷藏环境中取出，应平衡至室温后再使用。
2. 检测必须符合国家有关HBV检测的实验室管理及安全的规定，并按有关实验室规程处理所使用组份及样品。试剂盒组份内不同程度地含有对人体有害的试剂，注意不要将这些组份溅到眼睛、皮肤或衣服上，一旦发生，应立即用足量的水清洗受害部位。
3. 严格控制反应温度和时间，并尽量使用移液器加样，结果判定以酶标仪读数为准。
【贮存条件】：2-8℃       【有效期】：12个月

[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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【公司名称】 广州健仑生物科技有限公司
【市场部】    杨永汉

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【腾讯  】 2042552662
【公司地址】 广州清华科技园创新基地番禺石楼镇创启路63号二期2幢101-103室