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Clinical trial of ABO blood group reverse typing and blood group antibody titer POCT detection method

Evaluation of emergency blood collection and testing equipment under field conditions

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300078864
Enrollment
Unknown
Registered
2023-12-20
Start date
2023-12-20
Completion date
Unknown
Last updated
2024-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood group antibody detection

Interventions

Gold Standard:micro-column gel method, Product name ABO-Rh blood type test card (micro-column gel method)
Index test:A self-developed POCT detection device for blood type and antibody titers

Sponsors

The 909th Hospital of the Joint Logistic Support Force of PLA
Lead Sponsor

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 Samples of infants less than 4 months old and elderly people over 65 years old; 2. Samples with severe hemolysis, lipemia, turbidity, and contamination; 3 Samples that cannot be tested due to insufficient actual sample size; 4. Samples from patients with tumors, leukemia, aplastic anemia, multiple myeloma, Parkinson's disease, myelofibrosis, hematopoietic stem cell transplantation (including bone marrow transplantation), liver disease, tuberculosis, etc. that seriously affect blood group antibody detection; 5 The sample information is incomplete and should at least include: gender, age, sampling date, sample type, clinical diagnosis information and patient/sample unique identification (such as medical record number/medical record number/outpatient visit number, patient ID, sample number, etc.).

Design outcomes

Primary

MeasureTime frame
reverse blood grouping;Blood type antibody titer;

Countries

China

Contacts

Public ContactLIANG SHENGQIANG

The 909th Hospital of the Joint Logistic Support Force of PLA

Liangshengqiang1@163.com+86 138 5928 6852

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026