zh-cn	新型冠状病毒肺炎实验室检测技术指南
en-us	Technical Guidelines for COVID-19 Laboratory Testing

zh-cn	为指导各级疾控部门和其他相关机构开展新型冠状病毒肺 炎病例标本采集与实验室检测工作，特制定本技术指南。
en-us	These Technical Guidelines are formulated to guide disease control agencies and relevant institutions at all levels to carry out laboratory testing for 2019 novel coronavirus (2019-nCoV).

zh-cn	标本采集
en-us	Specimen Collection

zh-cn	采集对象
en-us	Collection Targets

zh-cn	新型冠状病毒肺炎疑似病例和聚集性病例，需要进行新型冠状病毒感染诊断或鉴别诊断者，
en-us	Collection targets include the following: suspected cases, clustered cases, and  other  cases requiring diagnosis or differential diagnosis for 2019-nCoV;

zh-cn	或其他需要进一步筛查检测的环境或生物材料。
en-us	or other  environmental or  biological substances that require further screening and testing.

zh-cn	标本采集要求
en-us	Collection Requirements

zh-cn	从事新型冠状病毒检测标本采集的技术人员应经过生物安全培训（培训合格）和具备相应的实验技能。
en-us	The  2019-nCoV  testing  specimens shall  be collected by qualified technicians who have received biosafety training (who have passed the training) and are equipped with the corresponding laboratory skills.

zh-cn	采样人员个人 防护装备（Personal Protective Equipment，PPE）要求：N95及以 上防护口罩、护目镜、连体防护服、双层乳胶手套、防水靴套；
en-us	Personal protective equipment (PPE) requirements for sampling personnel are: N95  masks or  masks with higher filtration efficiency, goggles, protective clothing, double-layer latex gloves and waterproof boot covers;

zh-cn	如果接触了患者血液、体液、分泌物或排泄物，应及时更换外 层乳胶手套。
en-us	if exposed to patients’  blood, body fluids, secretions or excretions, the outer layer of the latex gloves should be changed in time.

zh-cn	住院病例的标本由所在医院的医护人员采集。
en-us	Specimens of inpatient cases shall be collected by medical staff of the hospital where they are being treated.

zh-cn	密切接触者标本由当地指定的疾控机构、医疗机构负责采 集。
en-us	Specimens of close contacts shall be collected by the designated local CDCs and medical institutions.

zh-cn	根据实验室检测工作的需要，可结合病程多次采样。
en-us	Multiple specimens may be collected in the course of the disease, depending on the need for laboratory testing.

zh-cn	采集标本种类
en-us	Categories of Specimens Collected

zh-cn	每个病例必须采集急性期呼吸道标本（包括上呼吸道标本 或下呼吸道标本），
en-us	Respiratory tract  specimens in  the  acute  phase (including upper or lower respiratory tract specimens) must be collected from each case;

zh-cn	重症病例优先采集下呼吸道标本；
en-us	lower respiratory tract specimens shall be preferred for the collection from severe cases.

zh-cn	根据临床需要可留取便标本、全血标本、血清标本和尿标本。
en-us	Stool samples, whole blood samples, serum   samples  urine   specimens can   be   collected according to clinical needs.

zh-cn	标本种类：
en-us	Categories of specimen:

zh-cn	上呼吸道标本：包括鼻咽拭子、咽拭子等。
en-us	Upper respiratory tract specimens:including nasopharyngeal swabs, pharyngeal swabs, etc.

zh-cn	下呼吸道标本：深咳痰液、肺泡灌洗液、支气管灌洗液、 呼吸道吸取物等。
en-us	Lower respiratory tract specimens: including deep- cough sputum, alveolar lavage fluids, bronchial lavage fluid, and respiratory tract extracts.

zh-cn	便标本/肛拭子：留取粪便标本约10克（花生大小），
en-us	Fecal specimens/anal  swabs: Fecal samples are about 10 g (peanut size).

zh-cn	如果不便于留取便标本，可采集肛拭子。
en-us	If it is not convenient to collect fecal samples, an anal swab can be collected.

zh-cn	血液标本：尽量釆集发病后7天内的急性期抗凝血，
en-us	Blood specimens: One should, as much as possible, collect anticoagulated blood in the acute phase within 7 days after the onset of the disease.

zh-cn	采集量5ml，
en-us	A 5 mL quantity of blood is required for each collection.

zh-cn	建议使用含有EDTA抗凝剂的真空釆血管采集血液。
en-us	Vacuum tubes containing EDTA anticoagulant are recommended in blood collection.

zh-cn	血清标本：尽量釆集急性期、恢复期双份血清。
en-us	Serum specimens: Both  acute-phase and convalescent serum specimens should be collected as often as possible.

zh-cn	第一份血清应尽早（最好在发病后7天内）釆集，第二份血清应在发病后 第3～4周釆集。
en-us	The first serum specimen should be collected as soon as possible (preferably within 7 days after the onset of illness), and the second specimen should be collected during 3 or 4 weeks after the onset of illness.

zh-cn	采集量5ml，建议使用无抗凝剂的真空釆血管。
en-us	A 5 mL quantity of blood is required for each specimen and vacuum tubes without anticoagulant are recommended.

zh-cn	血清标本主要用于抗体的测定，不进行核酸检测。
en-us	Serum specimens are mainly used for measuring antibodies, rather than nucleic acid testing.

zh-cn	尿标本：留取中段晨尿，采集量2～3ml。
en-us	Urine  specimens: Collect 2–3  mL mid-stream of morning urine sample.

zh-cn	标本采集和处理。
en-us	Methods of Specimen Collection and Processing

zh-cn	1.鼻咽拭子：
en-us	Nasopharyngeal swab:

zh-cn	采样人员一手轻扶被采集人员的头部，一手执拭子，拭子贴鼻孔进入，沿下鼻道的底部向后缓缓深入，
en-us	The sampler gently holds the person's head with one hand,  the swab in  another, insert the swab via nostril to enter, slowly get deep along the bottom of the lower nasal canal.

zh-cn	由于鼻道呈弧形，不可用力过猛，以免发生外伤出血。
en-us	Because the nasal canal is curved, do not force too hard to avoid traumatic bleeding.

zh-cn	待拭子顶端到达鼻咽腔后壁时，轻轻旋转一周（如遇反射性咳嗽，应停留 片刻），然后缓缓取出拭子，将拭子头浸入含2～3ml病毒保存液（也可使用等渗盐溶液、组织培养液或磷酸盐缓冲液）的管中， 尾部弃去，旋紧管盖。
en-us	When the tip of the swab reaches the posterior wall of the nasopharyngeal cavity, rotate gently once (pause for a moment  in  case of reflex cough), then slowly remove the swab and dip the swab tip into a tube containing 2–3 mL virus preservation solution (or isotonic saline solution, tissue culture solution, or phosphate buffer), discard the tail, and tighten the cap.

zh-cn	咽拭子：
en-us	Pharyngeal swab:

zh-cn	被采集人员先用生理盐水漱口，采样人员将拭子 放入无菌生理盐水中湿润（禁止将拭子放入病毒保存液中，避免抗生素引起过敏），被采集人员头部微仰，嘴张大，并发“啊”音，露出两侧咽扁桃体，将拭子越过舌根，在被采集者两侧咽 扁桃体稍微用力来回擦拭至少3次，然后再在咽后壁上下擦拭至 少3次，将拭子头浸入含2～3ml病毒保存液（也可使用等渗盐溶 液、组织培养液或磷酸盐缓冲液）的管中，尾部弃去，旋紧管盖。
en-us	the sampled person first gargles with normal saline, the  sampler then  immerses the swabs in sterile saline (virus preservation solution is not allowed to avoid antibiotic allergies), holds the head of the sampled person up slightly with his or her mouth wide open making an “ah” sound to expose the lateral pharyngeal tonsils, insert the swabs, stick across the tongue roots, wipe both sides of the pharyngeal tonsils with pressure at least 3 times, then wipe on the upper and lower walls of the pharynx for at least 3 times, dip the swabs in a tube containing 2–3 mL storage solution (or isotonic saline solution, tissue culture solution, or phosphate buffer solution), discard the tail, and tighten the cap.

zh-cn	咽拭子也可与鼻咽拭子放置于同一管中。
en-us	The pharyngeal swabs can also be placed in the same tube together with the nasopharyngeal swab.

zh-cn	鼻咽抽取物或呼吸道抽取物：
en-us	Nasopharyngeal or respiratory tract extract:

zh-cn	用与负压泵相连的收集器从 鼻咽部抽取粘液或从气管抽取呼吸道分泌物。
en-us	Extract mucus from  the  nasopharynx or  extract respiratory secretions from the trachea with a collector connected to a negative-pressure pump;

zh-cn	将收集器头部插 入鼻腔或气管，接通负压，旋转收集器头部并缓慢退出，收集 抽取的粘液，并用3ml采样液冲洗收集器1次（亦可用小儿导尿 管接在50ml注射器上来替代收集器）。
en-us	insert the head of the collector into the nasal cavity or trachea, turn on the negative pressure, rotate and slowly withdraw the head of the collector, collect the extracted mucus, and rinse the collector once with 3 mL of the sampling solution (a pediatric catheter connected to a 50 mL syringe may be used as an alternative to the collector).

zh-cn	深咳痰液：
en-us	Deep cough sputum:

zh-cn	要求病人深咳后，将咳出的痰液收集于含3ml采样液的采样管中。
en-us	Ask the  sampled person to cough deeply and collect the sputum coughed up in a screw-capped plastic tube  containing 3  mL  of  the sampling solution.

zh-cn	如果痰液未收集于采样液中，可在检测前， 加入2～3ml采样液，或加入痰液等体积的痰液消化液。
en-us	If the sputum is not collected in the once with the sampling solution ,2–3 mL of the sampling solutioncan be added into the tube before testing, or sputum digestion  reagents  (Table 1)  of  equal  volume  to  the sputum can be added.

zh-cn	痰液消化液储存液配方见表1。
en-us	TABLE 1. Formula  of  storage  fluid  for  sputum  digestion reagents.

zh-cn	使用时将储存液用去离子水稀释至50 ml，与痰液等体积混合使用，
en-us	Dilute the storage solution to 50 mL with deionizedwater before use.

zh-cn	或者参照试剂说明进行使用，也可采用痰液等体积的 含1g/L蛋白酶K的磷酸盐缓冲液将痰液化。
en-us	Sputum can also be liquefied with a phosphate buffer containing 1 g/L of protease K in an equal volume of sputum.

zh-cn	支气管灌洗液
en-us	Bronchial  lavage  fluid

zh-cn	将收集器头部从鼻孔或气管插口处插入气管（约30cm深处），注入5ml生理盐水，接通负压，旋转收集器头部并缓慢退出，
en-us	Insert the head of the collector into the trachea (about 30 cm deep) from the nostril or the tracheal insertion part, inject 5 mL of physiological saline, turn  on  the  negative pressure, rotate the head of the collector and slowly withdraw it.

zh-cn	收集抽取的粘液，并用采样液冲洗收集器1次， 也可用小儿导尿管接在50ml注射器上来替代收集。
en-us	Collect the  extracted mucus and  rinse the  collector once with the sampling solution (a pediatric catheter connected to  a 50  mL syringe may be used as an alternative to  the  collector).

zh-cn	肺泡灌洗液
en-us	Alveolar lavage fluid:

zh-cn	局部麻醉后将纤维支气管镜通过口或鼻经过 咽部插入右肺中叶或左肺舌段的支气管，将其顶端契入支气管 分支开口，经气管活检孔缓缓加入灭菌生理盐水，每次30～50 ml，总量100～250ml，不应超过300ml。
en-us	After local anesthesia, insert a bronchoscope through the mouth or nose, pass through the pharynx into the branch of the right middle lobe or the lingular segment of the left lung, and insert the tip into the bronchial branch opening; slowly add sterilized physiological saline through the biopsy hole of the bronchoscope, with 30–50 mL of saline each time, 100–250 mL in total, 300 mL at most.

zh-cn	粪便标本
en-us	Fecal specimen:

zh-cn	取1ml标本处理液，挑取黄豆粒大小的便标本加至管中，轻轻吹吸3-5次，室温静置10分钟，以8000 rpm离心5 分钟，吸取上清液进行检测。
en-us	Take 1ml of the sample processing solution, pick up a little sample about the size of a soybean and add it into the tube, gently blow for 3–5 times, set aside at room temperature for 10 minutes, centrifuge at 8,000 rpm for 5 minutes, and absorb the supernatant for detection.

zh-cn	表2粪便标本处理液配方
en-us	TABLE 2. Formula of fecal sample processing solution.

zh-cn	也可使用HANK’S液或其它等渗盐溶液、组织培养液或磷酸盐缓冲液溶解便标本制备便悬液。
en-us	Stool suspensions can also be prepared using HANK’s solution or other isotonic saline solution, tissue culture solution, or phosphate buffer solution.

zh-cn	如患者出现腹泻症状，则留取粪便标本3～5ml，轻轻吹打混匀后，以8000 rpm离心5分钟， 吸取上清液备用。
en-us	If the patient has symptoms of diarrhea, collect 3–5 mL of stool specimen, gently blow and mix, centrifuge it at 8,000 rpm for 5 minutes, and absorb the supernatant to reserve for use.

zh-cn	肛拭子：
en-us	Anal swab:

zh-cn	用消毒棉拭子轻轻插入肛门3～5cm，再轻轻旋 转拔出，立即放入含有3～5ml病毒保存液的15ml外螺旋盖采样 管中，弃去尾部，旋紧管盖。
en-us	Gently  insert the  disinfectant cotton swab into the anus for 3–5 cm in depth, then gently rotate and pull out, immediately put the swab into a screw-capped sampling tube containing 3–5 mL virus preservation solution, discard the tail, and tighten the tube cover.

zh-cn	血液标本：
en-us	Blood samples:

zh-cn	建议使用含有EDTA抗凝剂的真空釆血管采集血液标本5ml，根据所选用核酸提取试剂的类型确定以全血或血 浆进行核酸提取。
en-us	It is recommended to use vacuum blood  vessels containing  EDTA  anticoagulant to collect 5 mL of blood samples. Nucleic acid extraction should be performed on whole blood or plasma according to the type of nucleic acid extraction reagent selected.

zh-cn	如需分离血浆，将全血1500～2000rpm离心10 分钟，收集上清于无菌螺口塑料管中。
en-us	For plasma separation, the  whole blood should be centrifuged at 1,500 to 2,000 rpm for 10 minutes, and the supernatant should be collected in a sterile plastic tube with a screw cap.

zh-cn	血清标本：
en-us	Serum specimen:

zh-cn	用真空负压采血管采集血液标本5ml，室温静 置30分钟，1500～2000rpm离心10分钟，收集血清于无菌螺口塑料管中。
en-us	Collect a 5 mL blood specimen with a vacuum negative-pressure blood collection tube. Keep the specimen at room temperature for 30 minutes, centrifuge it at 1,500–2,000 rpm for 10 minutes, and collect the serum in a sterile plastic tube with a screw cap.

zh-cn	依据设计需求规范采集。
en-us	To be collected in a standardized manner in accordance with design requirements.

zh-cn	标本包装。
en-us	Specimen Packaging

zh-cn	标本采集后在生物安全二级实验室生物安全柜内分装。
en-us	Collected specimens shall be packaged separately in a biosafety cabinet of a BSL-2 laboratory.

zh-cn	所有标本应放在大小适合的带螺旋盖内有垫圈、耐冷冻的样本采集管里，拧紧。
en-us	All specimens should be placed in  an  airtight freeze-tolerant sample collection tube of appropriate size with a screw cap and a gasket inside.

zh-cn	容器外注明样本编号、种类、姓名及采样日期。
en-us	The sample number, category, name, and sampling date should be indicated on the outside of the container.

zh-cn	将密闭后的标本装入密封袋，每袋限一份标本。
en-us	Specimens kept in an airtight container should be sealed in a plastic bag of appropriate  size, with each bag containing one specimen.

zh-cn	样本包装要求要符合《危险品航空安全运输技术细则》相应的标准。
en-us	The specimen packaging requirements must meet the corresponding standards of the Technical  Regulations for the Safe Transport of Dangerous Goods by Air.

zh-cn	涉及外部标本运输的，应根据标本类型，按照A类或B类 感染性物质进行三层包装。
en-us	Prior to transportation, external specimens shall undergo the three-layer packaging applicable to Category A and Category B infectious substances based on the categories of the specimens.

zh-cn	标本保存
en-us	Specimen Preservation

zh-cn	用于病毒分离和核酸检测的标本应尽快进行检测，可在24小时内检测的标本可置于4℃保存；
en-us	Specimens for  virus  isolation  and  nucleic  acid detection purposes should be tested as soon as possible.

zh-cn	24小时内无法检测的标本则应置于-70℃或以下保存（如无-70℃保存条件，则于-20℃冰箱暂存）。
en-us	Specimens to be tested within 24 hours can be stored at 4 °C; those that cannot be tested within 24 hours should be stored at –70 °C or below (specimens may be temporarily stored in –20 °C refrigerators  in the absence of –70 °C storage condition).

zh-cn	血清标本可在4℃存放3天，-20℃以下可长期保存。
en-us	Serum can be stored at 4 °C for 3 days and below –20 °C for a longer period.

zh-cn	应设立专库或专柜单独保存标本。
en-us	A special depot or cabinet is required to store specimens separately.

zh-cn	标本送检
en-us	Specimen Submission and Examination

zh-cn	标本采集后应尽快送往实验室，
en-us	Collected specimens should be sent to laboratories as soon  as  possible.

zh-cn	如果需要长途运输，建议采用干冰等制冷方式进行保藏。
en-us	Dry  ice  and  other  refrigeration methods  are  recommended for  the  preservation of specimens to be transported over long distances.

zh-cn	标本运送期间应避免反复冻融。
en-us	Repeated freeze-thaw cycles during specimen transportation should be avoided.

zh-cn	上送标本各省（自治区、直辖市）5例及以上的聚集性病例，以及境外输入病例的所有原始标本上送中国疾病预防控制中心病毒病 预防控制所进行检测复核，并附样本送检单（见附表）。
en-us	Specimens  of   cluster  cases  in   each   province (autonomous region, municipality directly under the central government) shall be submitted to the National Institute  for  Viral Disease Control  and  Prevention (NIVDC) of China CDC for testing and review with the specimen submission form attached (see Appendix).

zh-cn	标本及毒株运输
en-us	Pathogen and specimen transportation

zh-cn	国内运输
en-us	Domestic transport

zh-cn	新型冠状病毒毒株或其它潜在感染性生物材料的运输包装分类属于A类，对应的联合国编号为UN2814，包装符合国际民 航组织文件Doc9284《危险品航空安全运输技术细则》的PI602 分类包装要求；
en-us	Strains of 2019-nCoV or other potentially infectious biological substances are subject to  packaging instructions for  Category A  substances assigned to UN2814, and the PI 602 of the Technical Instructions For The Safe Transport of Dangerous Goods by Air (Doc 9284) issued by ICAO;

zh-cn	环境样本属于 B 类，对应的联合国编号为 UN3373，包装符合国际民航组织文件Doc9284《危险品航空安全运输技术细则》的PI650分类包装要求；
en-us	environmental samples, assigned to UN3373, shall be transported in Category B packaging in accordance with the PI 650, Doc 9284;

zh-cn	通过其他交通工具运输的可参照以上标准包装。
en-us	one may refer to  the  aforementioned standards for specimens to  be transported in  other  modes of transportation.

zh-cn	新型冠状病毒毒株或其它潜在感染性材料运输应按照《可 感染人类的高致病性病原微生物菌（毒）种或样本运输管理规 定》（原卫生部令第45号）办理《准运证书》。
en-us	A  Permit of Transport is  required for  the transportation of the 2019-nCoV strains or other potentially infectious substances according to  the Transport Regulations on  the  Highly  Pathogenic Microorganism  (Virus) Strains and Specimens  that are Pathogenic to Humans (Order No. 45, former Ministry of Health).

zh-cn	国际运输
en-us	International transport

zh-cn	在国际间运输的新型冠状病毒标本或毒株，应规范包装，按照《出入境特殊物品卫生检疫管理规定》办理相关手续，并 满足相关国家和国际相关要求。
en-us	Standard packaging shall be applied to 2019-nCoV strains or  samples to  be transported internationally, with relevant procedures handled in accordance with the  Provisions  on  the  Administration of  the  Health Quarantine of Entry/Exit Special Articles as  well as relevant national and international requirements.

zh-cn	标本和毒株管理
en-us	Management of strains and samples

zh-cn	新型冠状病毒标本及毒株应由专人管理，准确记录毒株和样本的来源、种类、数量，编号登记，采取有效措施确保毒株 和样本的安全，严防发生误用、恶意使用、被盗、被抢、丢失、 泄露等事件。
en-us	2019-nCoV strains and samples should be managed by designated personnel with accurate records of the source, category, quantity, and registration number of the strains and samples. Effective measures should be adopted to ensure the security of the strains and samples. Efforts should be made to prevent the misuse, malicious use, theft, robbery, loss, and leakage of the strains and samples.

zh-cn	新型冠状病毒的实验室检测
en-us	Laboratory Testing of the 2019-nCoV

zh-cn	实时荧光RT-PCR方法检测新型冠状病毒核酸。
en-us	Real-Time Fluorescence-based Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) assay of the 2019-nCoV Nucleic Acid

zh-cn	新型冠状病毒核酸检测
en-us	2019-nCoV nucleic acid assay

zh-cn	本指南中的核酸检测方法主要针对新型冠状病毒基因组中开放读码框1ab（open reading frame 1ab，ORF1ab）和核壳蛋白(nucleocapsid protein，N)
en-us	The  nucleic acid detection method  introduced in this guideline mainly targets at open reading frame 1ab (ORF lab) and nucleocapsid protein (N) genes in the 2019-nCoV genome.

zh-cn	核酸提取和实时荧光RT-PCR反应体系及反应条件参考相关厂家试剂盒说明。
en-us	For nucleic acid extraction and real-time fluorescence-based RT-PCR   reaction   system  and reaction conditions, refer to kit instructions of the manufacturers concerned.

zh-cn	Ct值在37-40之间，建议重复实验，若重做结果Ct值<40，扩增曲线有明显起峰，该样本判断为阳性,否则为阴性。
en-us	if Ct values range between 37 and 40. If the Ct value reads <40 and the amplification curve has an obvious peak, the sample should be considered to be positive, otherwise it should be considered as negative.

zh-cn	注：如使用商品化试剂盒，则以厂家提供的说明书为准。
en-us	Note: If a commercial kit is used, the instructions provided by the manufacturer will take priority. Confirmation of cases

zh-cn	病例确认
en-us	Judgment of results

zh-cn	实验室确认阳性病例需满足以下两个条件中的一个：
en-us	Laboratory confirmation of positive cases requires one of the following two conditions:

zh-cn	同一份标本中新型冠状病毒2个靶标（ORF1ab、N） 实时荧光RT-PCR检测结果均为阳性。
en-us	The real-time fluorescence-based RT-PCR assay of 2019-nCoV in the same specimen shows that the two targets, ORF1ab and Protein N, are both positive.

zh-cn	如果出现单个靶标阳性的 检测结果则需要重新采样，重新检测。
en-us	In case of the result showing positive for one target, then samples shall be re-collected for another test.

zh-cn	如果仍然为单靶标阳 性，判定为阳性。
en-us	If it is still positive for a single target, the result should be deemed positive.

zh-cn	两种标本实时荧光RT-PCR同时出现单靶标阳性，或同种类型标本两次采样检测中均出现单个靶标阳性的检测结果， 可判定为阳性。
en-us	The real-time fluorescence-based RT-PCR assay of two types of specimens show one single target as positive at the same time, or one target as positive in two samples of the same type, the result should be deemed positive.

zh-cn	核酸检测结果阴性不能排除新型冠状病毒感染，
en-us	Negative nucleic acid results cannot rule out 2019- nCoV infections.

zh-cn	需要排除可能产生假阴性的因素，包括：样本质量差，比如口咽等部位 的呼吸道样本；样本收集的过早或过晚；没有正确的保存、运 输和处理样本；技术本身存在的原因，如病毒变异、PCR抑制等。
en-us	Factors leading to false negatives shall be precluded including: poor quality of samples, for instance the respiratory tract samples of the oropharynx and other parts; samples collected too early or too late; samples that  are improperly stored, transported, or processed; technical reasons such as virus mutations, PCR inhibition, etc.

zh-cn	血清抗体检测。
en-us	Serum Antibody Tests

zh-cn	血清抗体检测（胶体金、磁微粒化学发光、ELISA）用作新型冠状病毒核酸检测阴性病例的补充检测，在疑似病例诊断中与核酸检测协同使用，或用于人群血清学调查和既往暴露调查。
en-us	Serum  antibody  tests  (colloidal gold,  magnetic particle  chemiluminescence, ELISA) are  used  as supplementary tests for cases of negative 2019-nCoV nucleic acid tests, used in  conjunction with nucleic acid tests in the diagnosis of suspected cases, or used in serological surveys and  past  exposure surveys of concerned population groups.

zh-cn	实验室确认阳性病例需满足以下两个条件中的一个：
en-us	Laboratory confirmed positive cases need to meet one of the following two conditions:

zh-cn	血清新型冠状病毒IgM和IgG抗体阳性；
en-us	Serum IgM antibodies and/or IgG antibodies to 2019-nCov are positive;

zh-cn	血清新型冠状病毒IgG抗体由阴性转为阳性或恢复期较急 性期有4倍及以上升高。
en-us	Serum IgG antibodies to 2019-nCov turn from negative to  positive or  the  IgG  antibody titers  of recovery period are 4 times or more higher than that of acute phase.

zh-cn	发病后7天内的急性期抗凝血用于IgM和IgG检测，如果检测结果阴性，建议发病后10天内再次采集进行检测。
en-us	Using serum in the acute phase within 7 days after the onset of disease detects IgM and IgG, if the test result is negative, repeat collection for testing within 10 days after the  onset of disease is recommended.

zh-cn	发病后3-4周恢复期血清用于IgG检测。
en-us	Convalescent serum specimens within 3–4 weeks after the onset of illness should be used for detecting IgG.

zh-cn	如果采用商品化试剂盒，则以厂家说明书为准。
en-us	Instructions from the manufacturer's manual should be followed for commercial testing kits.

zh-cn	实验室活动生物安全要求
en-us	Biosafety requirements for pathogen experiments

zh-cn	根据目前掌握的新型冠状病毒的生物学特点、流行病学特 征、临床资料等信息，该病原体暂按照病原微生物危害程度分 类中第二类病原微生物进行管理，
en-us	According to the biological features, epidemiological characteristics, clinical data,  and  other  available information concerning the 2019-nCoV, the pathogen shall be temporally managed as a Category B pathogen and microorganism based on  its hazards.

zh-cn	具体要求如下：
en-us	Specific requirements are listed as follows:

zh-cn	病毒培养
en-us	Viral Culture

zh-cn	病毒培养是指病毒的分离、培养、滴定、中和试验、活病 毒及其蛋白纯化、病毒冻干以及产生活病毒的重组实验等操作。
en-us	Viral  culture  refers to  operations such  as  virus isolation, culture, titration, neutralization test, purification of live virus and its protein, lyophilization of virus, and recombination test to produce live virus.

zh-cn	上述操作应当在生物安全三级实验室的生物安全柜内进行。
en-us	The above operations should be performed in a biosafety cabinet in a BSL-3 laboratory.

zh-cn	使用病毒培养物提取核酸，裂解剂或灭活剂的加入必须在与病毒 培养等同级别的实验室和防护条件下进行，裂解剂或灭活剂加 入后可比照未经培养的感染性材料的防护等级进行操作。
en-us	When viral medium is used to extract nucleic acid, the addition of lysing agent or inactivating agent must be performed under the same level of laboratory and protective conditions as viral culture.

zh-cn	实验室开展相关活动前，应当报经国家卫生健康委批准，取得开展 相应活动的资质。
en-us	Laboratories shall report to the  National  Health  Commission for approval and obtain relevant qualifications before carrying out the corresponding activities.

zh-cn	动物感染实验
en-us	Animal Infection Experiments

zh-cn	动物感染实验是指以活病毒感染动物、感染动物取样、感染性样本处理和检测、感染动物特殊检查、感染动物排泄物处 理等实验操作，应当在生物安全三级实验室的生物安全柜内操作。
en-us	Animal infection experiments refer to  operations such as infecting animals with live viruses, sampling of infected animals, processing and testing of infectious samples, special test for infected animals, disposal of infected animal excrement, etc., which should be performed in a biosafety cabinet in a BSL-3 laboratory.

zh-cn	实验室开展相关活动前，应当报经国家卫生健康委批准， 取得开展相应活动的资质。
en-us	Laboratories shall report  to  the  National  Health Commission for approval and obtain relevant qualifications before carrying out  the  corresponding activities.

zh-cn	未经培养的感染性材料的操作
en-us	Operations of Uncultured Infectious Substances

zh-cn	未经培养的感染性材料的操作是指未经培养的感染性材料 在采用可靠的方法灭活前进行的病毒抗原检测、血清学检测、 核酸提取、生化分析，以及临床样本的灭活等操作，
en-us	Operations of uncultured infectious substances refer to viral antigen detection, serological testing, nucleic acid extraction, biochemical analysis, inactivation of clinical samples, and other operations performed on uncultured  infectious substances before inactivation through a reliable method.

zh-cn	应当在生物安全二级实验室进行，同时采用生物安全三级实验室的个人防护。
en-us	The operation should be performed in a BSL-2 laboratory with personal protective equipment subject to BSL-3 laboratory protection requirements.

zh-cn	灭活材料的操作。
en-us	Operations of Inactivated Substances

zh-cn	感染性材料或活病毒在采用可靠的方法灭活后进行的核酸 检测、抗原检测、血清学检测、生化分析等操作应当在生物安 全二级实验室进行。
en-us	After reliable inactivation of infectious substances or live viruses, operations such as nucleic acid testing, antigen testing, serological testing, and  biochemical analysis should be performed in a BSL-2 laboratory.

zh-cn	分子克隆等不含致病性活病毒的其他操作， 可以在生物安全一级实验室进行。
en-us	Molecular cloning and other operations not involving live pathogenic viruses may be carried out in a BSL-1 laboratory.

zh-cn	基因序列同源性非必选项，
en-us	Gene sequence homology is not a required option;

zh-cn	注明完成具体靶基因序列/全基因组序列，及其与新型冠状病毒的同源性。
en-us	it indicates completion of the specific target gene sequence / whole genome sequence and its homology with 2019-nCoV.

zh-cn	样本来源是否为聚集性病例§填是或否。
en-us	For the column of “from a clustered break or not”, fill in “yes” or “no”.