临床试验总体要求及临床试验资料的内容应符合《办法》、2014年第44号公告和《体外诊断试剂临床试验技术指导原则》的规定，以下仅结合ABO、RhD血型抗原检测卡的具体特点对其临床试验中应重点关注的内容进行阐述。

1.研究方法

按照法规要求应选择境内已批准上市、临床普遍认为质量较好的同类产品或试管法作为对比试剂，采用试验用体外诊断试剂（以下称考核试剂）与之进行比较研究试验，证明考核试剂与已上市产品或试管法等效。

2.临床试验单位的选择

应选择符合法规要求资质的临床试验机构进行临床试验，不得选择血站进行临床试验。

3.病例选择

临床总病例数应不少于3000例。应采用临床患者进行临床研究，供血者样本不得作为临床病例纳入。应包括血型鉴定易产生干扰的病例，尽量选择多种疾病患者（如肿瘤患者、自身免疫病患者、血液病患者）、老人、儿童（不同年龄段）等。血型分布尽量均衡，ABO血型每种均应有统计学意义，RhD阴性样本建议不少于50例。

4.实验过程

分别采用考核试剂与对比试剂依据各自的说明书对入组临床样本进行血型检测，记录结果应具体到凝集强度。

5.统计学分析

应分别进行考核试剂与对比试剂对不同ABO血型、RhD血型的阳性符合率、阴性符合率、总符合率的计算，并以四格表的形式进行列表，对定性结果进行Kappa检验以验证检测结果的一致性。

6.结果差异样本的验证

对于两种试剂检测结果不一致（包括考核试剂与对比试剂定型结果不一致、考核试剂与对比试剂凝集强度差异较大，如≥2+）的样本，应采用临床上公认较好的第三种同类试剂进行确认试验，同时应结合样本的复测结果进行综合分析，zui终应采用适合的方法进行样本血型的zui终确认。

如临床样本中包含凝集强度小于3+的样本，应进行进一步确认，明确出现弱凝集的原因。

7.临床试验数据记录表应作为临床试验报告附件提交。临床试验数据记录表应列明所有病例的具体临床诊断信息、凝集强度和血型定型结果，如有不符样本应列明第三方确认的结果。

8.临床试验中应注意考核试剂与对比试剂应严格遵守说明书操作要求，如红细胞悬液浓度、离心条件等，应与说明书一致。

The general requirements for clinical trials and the contents of clinical trial data shall comply with the provisions of the Measures, Announcement No. 44 of 2014 and the Technical Guidelines for Clinical Trials of In Vitro Diagnostic Reagents. The following only describes the contents that should be focused on in clinical trials in combination with the specific characteristics of ABO and RhD blood group antigen detection cards.

1. Research methods

According to the requirements of laws and regulations, the same kind of products or test tube methods that have been approved for marketing in China and generally considered to be of good quality in clinical practice shall be selected as the reference reagents, and the in vitro diagnostic reagents for testing (hereinafter referred to as the test reagents) shall be used for comparative research and test to prove that the test reagents are equivalent to the products or test tube methods that have been marketed.

2. Selection of clinical trial units

A clinical trial institution with the qualification required by laws and regulations shall be selected for clinical trials, and blood stations shall not be selected for clinical trials.

3. Case selection

The total number of clinical cases shall not be less than 3000. Clinical patients shall be used for clinical research, and blood donor samples shall not be included as clinical cases. It should include cases that are easy to interfere with blood type identification, and try to select patients with multiple diseases (such as cancer patients, patients with autoimmune diseases, patients with blood diseases), the elderly, children (different age groups), etc. The distribution of blood groups should be balanced as far as possible. Each ABO blood group should have statistical significance. It is recommended that no less than 50 RhD negative samples be taken.

4. Experimental process

The blood type of the clinical samples included in the group shall be tested with the examination reagent and the contrast reagent according to their respective instructions, and the recorded results shall be specific to the agglutination intensity.

5. Statistical analysis

The positive coincidence rate, negative coincidence rate and total coincidence rate of different ABO blood types and RhD blood types shall be calculated by the examination reagent and comparison reagent respectively, and the results shall be listed in the form of four grid tables. The qualitative results shall be tested by Kappa test to verify the consistency of the test results.

6. Validation of samples with different results

For samples with inconsistent test results of two reagents (including inconsistent sizing results of examination reagent and comparison reagent, and large difference in agglutination strength between examination reagent and comparison reagent, such as ≥ 2+), the third reagent of the same kind recognized clinically as good shall be used for confirmation test. At the same time, comprehensive analysis shall be carried out in combination with the retest results of samples. Finally, appropriate methods shall be used for the final confirmation of sample blood type.

If clinical samples contain samples with agglutination strength less than 3+, further confirmation shall be made to determine the cause of weak agglutination.

7. The clinical trial data record form shall be submitted as an attachment to the clinical trial report. The clinical trial data record form shall list the specific clinical diagnosis information, agglutination intensity and blood typing results of all cases. In case of any inconsistent samples, the results confirmed by the third party shall be listed.

8. In the clinical trial, it should be noted that the examination reagent and contrast reagent should strictly comply with the operation requirements of the manual, such as the concentration of red blood cell suspension, centrifugation conditions, etc., which should be consistent with the manual.