None listed
Conditions
Interventions
Gold Standard:Blood Test
Index test:Product name: DG Gel ABO-CDE
Purpose of use / Intended use Reference Reagent for reverse blood typing test (Fully Automated Method, Manual Method)
Product specifications: 4 x 12 cards/box
2 x 25 cards/box
Registration certificate holder: Diagnostic Grifols, S.A.
Agent: Grifols Pharmaceutical Technology (Shanghai) Co., Ltd.
Storage conditio
Sponsors
The Seventh Medical Center of the General Hospital of the Chinese People's Liberation Army
Eligibility
Sex/Gender
All
Age
0.3 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Remaining anticoagulated venous whole blood samples and serum samples collected during routine clinical testing in various clinical trial centers; 2. For anticoagulant venous whole blood samples, the anticoagulant used can be EDTA, citrate or heparin sodium; 3. The visual sample volume shall not be less than 1 mL; 4. Sample validity period: Samples stored at 2 - 8°C, within 48 hours after collection;
Exclusion criteria
Exclusion criteria: 1. For ABO reverse typing test, clinical routine blood donor samples; 2. For Cross-match test, discordant samples for ABO blood group; 3. Visually inspect the samples with severe hemolysis, cloudy and contamination; 4. Samples with insufficient actual volume for test; 5. Samples that do not meet the sample collection and processing requirements; 6. Samples with incomplete information, which shall at least include sex, age, sampling date, sample type, clinical diagnosis information, and unique patient/sample identification (eg, medical record number / case number / outpatient visit number, patient ID, sample number); 7. Samples from babies younger than 4 months old.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood Test; | — |
Countries
China
Contacts
Public ContactWu Tao
The Seventh Medical Center of the General Hospital of the Chinese People's Liberation Army
Outcome results
None listed