新型冠状病毒(2019-nCoV)IgM/IgG 抗体检测试剂盒（胶体金免疫层析法）
IgM/IgG antibody detection kit for novel coronavirus (2019-nCov) (colloidal gold immunochromatography)
使用说明书
Operating Manual
【产品名称】
【Product Name】
通用名称：新型冠状病毒(2019-nCoV)IgM/IgG 抗体检测试剂盒（胶体金免疫层析法）
Generic name: IgM/IgG antibody detection kit for novel coronavirus (2019-nCov) (colloidal gold immunochromatography)
【包装规格】
【Packing Specifications】
1 人份/袋，1 人份/盒、20 人份/盒、50 人份/盒。
1 test/bag, 1 test/box, 20 tests/box, 50 tests/box.
【预期用途】
【Intended Use】
本试剂盒运用免疫胶体金层析技术，实现对人体血清、血浆或全血中新型冠状病毒IgM/IgG 抗体的体外定性检测。
2019 新型冠状病毒，缩写为2019-nCoV，是2019 年在人体中发现的冠状病毒新毒株。该病毒症状一般为发热、乏力、干咳、逐渐出现呼吸困难，严重者表现为急性呼吸窘迫综合征，脓毒症休克，难以纠正的代谢性酸中毒和凝血功能障碍。该病毒已确认存在人传人现象，病毒潜伏期最短有1 天发病，最长的潜伏期是14 天，潜伏期具有传染性，所致疾病没有特异治疗方法。人首次感染新型病毒后，机体的免疫系统会对病毒进行免疫防御，产生特异性的抗体。一般1-2 周出现IgM 抗体，4 周出现IgG 抗体。
This kit uses immunocolloidal gold chromatography to detect novel coronavirus IgM/IgG antibodies in human serum, plasma or whole blood in vitro.
The 2019 novel coronavirus, abbreviated as 2019-ncov, is a new strain of coronavirus discovered in the human body in 2019. The symptoms of the virus are fever, fatigue, dry cough, and progressive dyspnea. In severe cases, the symptoms are acute respiratory distress syndrome, septic shock, metabolic acidosis and coagulation dysfunction that can’t be corrected. The virus has been confirmed to exist the phenomenon of human-to-human transmission, the shortest incubation period of the virus is only 1 day, and the longest incubation period is 14 days. The patients in incubation period is contagious and there is no specific treatment for the disease. . After a human is infected with a new virus for the first time, the body's immune system will immune-defend the virus and produce specific antibodies. Generally, IgM antibody will appear in 1-2 weeks and IgG antibody will appear in 4 weeks.
【检验原理】
【Testing Principle】
本产品采用免疫层析方法，检测卡含有胶体金标记新型冠状病毒重组抗原和金标记兔IgG 抗体，在硝酸纤维素膜检测线包被抗人IgM 与抗人IgG 混合物，质控线包被羊抗兔IgG。当进行检测时，若样本中存在新型冠状病毒抗体，则在硝酸纤维素膜检测线形成“新型冠状病毒抗原胶体金—冠状病毒抗体—抗人IgM/IgG”复合物而凝聚显色，表明是阳性结果；若样本中无新型冠状病毒抗体，则形成的复合物不足以凝聚显色，表明是阴性结果。
This product adopts the method of immunochromatography, the detection card contains colloidal gold labeled novel coronavirus recombinant antigen and gold labeled rabbit IgG antibody, and is coated with the mixture of anti-human IgM and anti-human IgG in the nitrocellulose-membrane
detection line, and the quality control line is coated with sheep anti-rabbit IgG. When testing, if there is a novel coronavirus antibody in the sample, then the "novel coronavirus antigen colloidal gold -coronavirus antibody - anti-human IgM/IgG" complex is formed in the nitro cellulose membrane
detection line to coagulate and display color, indicating a positive result. In the absence of antibodies to the novel coronavirus in the sample, the complex formed is insufficient to coagulate to produce color, indicating a negative result.
【主要组成成分】
【Main Components】
1. 检测卡：包被有新型冠状病毒重组抗原胶体金、兔IgG 胶体金、抗人IgM、抗人IgG、羊抗兔IgG
2. 使用说明书（1 份）
3. 样本稀释液。主要成分为磷酸缓冲液
4. 产品中不包含，但对试验必须的物品包括：取样器、计时器、采血器。
1. Detection card: coated novel coronavirus recombinant antigen colloidal gold, rabbit IgG colloidal gold, anti-human IgM, anti-human IgG, sheep anti-rabbit IgG
2. Operating manual (1 copy)
3. Sample diluent. The main component is phosphoric acid buffer
4. It is not included in the product, but necessary items for the test include: sampler, timer and blood collector.
【储存条件及有效期】
【Storage Conditions and Validity】
4～30℃避光干燥保存，有效期暂定为12 个月。
禁止冷冻或在已过有效期后使用。
生产日期及失效日期见包装标签。
4 ~ 30℃ storage in dark and dry, the validity is tentatively 12 months. Freezing or use after expiration is prohibited. Production date and expiry date are shown on the packaging label.
【样本要求】
【Sample Requirements】
（1）本检测试剂盒可用于血清、血浆或全血的检测。
（2）血清血浆样本短期（1 周）内进行检测可存放于2～8℃，一周以上应存放于-20℃以下并避免反复冻融；全血样本必须使用新鲜样本。
（3）可用于肝素、EDTA、枸橼酸钠等抗凝剂样本。
(1) This kit can be used for the detection of serum, plasma or whole blood.
(2) Serum and plasma samples can be stored at 2 ~ 8℃ for a short period of time (1 week), and below -20℃ for more than one week and avoid repeated freezing and thawing; whole blood samples must be fresh.
(3) It can be used for samples of heparin, EDTA, sodium citrate and other anticoagulants.
【检验方法】
【Inspection Method】
在进行检验前必须完整阅读使用说明书，使用前将原包装的试剂卡以及需检测的血液样本平衡到室温。
1.使用前从原包装铝箔袋取出试剂卡，水平放置。检测试剂应在铝箔袋打开后尽快使用。
2.用移液器吸取10uL 样本，加入加样孔中，再立即添加两滴（约70uL）稀释液。
3.加样后15 分钟内观察结果。
Read the manual thoroughly before testing and balance the reagent card in the original package and the blood sample to room temperature before using.
1. Before use, remove the reagent card from the original aluminum foil bag and place it horizontally. Test reagents should be used as soon as possible after the foil bag is opened.
2. Use the pipette to absorb 10uL sample, add it into the sample hole, and add two drops (about 70uL) diluent immediately.
3. Observe the results within 15 minutes after sample addition.
【阳性判断值】
【Positive Judgment Value】
以肉眼观察结果作为判断：当用肉眼能够观察到检测线位置出现红色条带（无论显色深浅）时，则判定为阳性。
当用肉眼无法在检测线位置观察到红色条带，则判定为阴性。
Judging by visual observation results:
When the red strip (regardless of the depth of color rendering) can be observed with the naked eye at the position of the detection line, it is determined to be positive.
When the red strip cannot be observed at the position of the detection line with the naked eye, it is judged to be negative.
【检测结果的解释】
【Interpretation of Test Results】
阳性结果：在试纸板的检测线和质控线位置上各出现一条红色条带。
阴性结果：仅试纸板的质控线位置上出现一条红色条带。
无效结果：在试纸板的检测线和质控线位置上均未出现红色条带，或者只有检测线出现一条红色条带而质控线未出现条带。
检测结果的说明：
1. 当检测结果显示“阴性”，但仍出现相关症状，建议及时去进行进一步的检查，确诊病因。
2. 当检测结果显示“阳性”，建议立即进行进一步复核。
Positive results: red strips appeared on the test zone and the quality control zone of the test board.
Negative results: only a red strip appeared on the quality control zone of the test board.
Invalid results: no red strip appeared on the test zone or the quality control zone of the test board, or only one red strip appeared on the test zone, but no strip appeared on the quality control zone.
Description of test results:
1. When the test results show "negative", but relevant symptoms still occur, it is recommended to conduct further examinations in time to confirm the cause.
2. When the test results show "positive", it is recommended to conduct further review immediately.
【检验方法的局限性】
1. 该试剂仅用于检测人血清、血浆或全血/手指样本中的新型冠状病毒IgM/IgG 抗体，其它体液和样本可能得不到正确结果。
2. 该试剂为定性试剂。
3. 必须按照上述检验方法步骤操作。
4. 通过其他方法得到的检测结果与本产品测定结果不具有直接的可比性。
5. 本试剂盒的检测结果仅供参考，不得作为临床诊治的唯一依据，对患者的临床管理应结合其症状、体征、病史、其他实验室检查及治疗反应等情况综合考虑。
6. 由于操作及样本的原因可能会出现可疑的结果，此时应进行重复检测，确保结果的一致。
【Limitations of Test Methods】
1. This reagent is only used to detect IgM/IgG antibodies against novel coronavirus in human serum, plasma or whole blood/finger samples. Other body fluids and samples may not get correct results.
2. The reagent is a qualitative reagent.
3. The above inspection methods must be followed.
4. The test results obtained by other methods are not directly comparable with the test results of this product.
5. The test results of this kit are for reference only and shall not be used as the sole basis for clinical diagnosis and treatment. The clinical management of patients should be considered in combination with their symptoms, signs, medical history, other laboratory tests and treatment responses.
6. There may be suspicious results due to the operation and samples. At this time, repeated tests should be conducted to ensure the consistency of the results.
【产品性能指标】
【Product Performance Indicators】
1. 阴性参考品：检测企业阴性参考品，要求检测结果应全部为阴性，即阴性符合率为100%
2. 阳性参考品：检测企业阳性参考品，要求检测结果应全部为阳性，即阳性符合率为100%。
3. 最低检出限：检测企业最低检出限参考品，要求检测结果为阳性。
4. 精密性：检测企业精密性参考品，检测10 次，要求反应结果应一致，显色度均一。
1. Negative reference: to test the negative reference of enterprises, the test results should be all negative, that is, the coincidence rate of negative is 100%
2. Positive reference: the enterprise positive reference should be tested, and the test results should be all positive, that is, the positive coincidence rate should be 100%.
3. Minimum detection limit: the minimum detection limit reference of the testing enterprise shall be positive.
4. Precision: the precision reference of the enterprise shall be tested for 10 times. The reaction results shall be consistent, and the chromaticity shall be uniform.
【注意事项】
【Attentions】
1. 本品仅用于体外诊断，使用前请详细阅读本说明书。
2. 如发现试纸卡铝箔袋破损则需废弃。
3. 检测过程中所有的样本和材料，应严格按传染病实验室操作规范处理。
4. 请保证足量的样本用于检测，过少的样本量都有可能导致结果出现无效。
5. 本产品为目视读取结果，为保证判读结果的正确，请勿在光线昏暗处对结果进行判读。
6. 不能使用溶血的样本进行检测。
7. 含有较高滴度的嗜异性抗体或类风湿因子的样本可能会影响预期结果。
8. 本试剂盒适用于疑似新型冠状病毒患者初筛用，最终结果应当由临床医生结合临床症状和其他实验室检测指标综合确定。
1. This product is only used for in vitro diagnosis. Please read this manual carefully before use.
2. If the aluminum foil bag of test card is found broken, it should be discarded.
3. All samples and materials in the testing process shall be handled in strict accordance with the operating standards of the infectious disease laboratory.
4. Please ensure that sufficient samples are used for testing. Far from enough samples may lead to invalid results.
5. This product is visual reading result. In order to ensure the accuracy of reading result, please do not read the result in dim light.
6. Hemolytic samples should not be used for testing.
7. Samples containing a higher titer of heterophobic antibodies or rheumatoid factors may affect the expected results.
8. This kit is suitable for the initial screening of patients with suspected novel coronavirus, and the final result should be determined by the clinician in combination with clinical symptoms and other laboratory test indicators.
【参考文献】
【References】
1. 国家卫生健康委“新型冠状病毒感染的肺炎诊疗方案”（试行第三版）
2. World Health Organization: Clinical management of severe acute respiratory infection when Novel coronavirus (nCoV) infection is suspected: Interim Guidance
1. "Pneumonia diagnosis and treatment program for novel coronavirus infection" of the National Health Commission of People’s Republic of China (Trial Version 3)
2. World Health Organization: Clinical management of severe acute respiratory infection when Novel coronavirus (nCoV) infection is suspected: Interim Guidance
【注册人】/【生产企业】
【Registrant】/【Manufacturer】
注册人/生产企业名称：上海********生物科技有限公司
住所：中国（上海）自由贸易试验区********5 号楼4 楼
邮编：201203
电话：021-********
传真：021-********
售后服务单位名称：上海********生物科技有限公司
邮编：201203
电话：021-********
传真：021-********
生产地址：中国（上海）自由贸易试验区********号楼3 楼（质检）、4 号楼3 楼（生产）、5号楼3 楼（质检、研发）
Name of registrant/manufacturer: Shanghai ******** Biotech Co.LTD
Zip code: 201203
Telephone: 021-********
Fax: 021-********
After-sales service unit: Shanghai ******** Biotech Co.LTD
Zip code: 201203
Telephone: 021-********
Fax: 021-********
Production address: ********, no. 151 ******** road, Shanghai, China
【医疗器械生产许可证编号】沪食药监械生产许20132041 号
【医疗器械注册证编号/产品技术要求编号】
【说明书批准及修改日期】
【Medical Device Production License No.] 】
Shanghai food and drug administration device production no. 20132041
【Medical Device Registration Certificate No. / Product Technical Requirements No. 】
【Date of Approval and Modification of Specification】
