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The purpose of this study is to assess the consistency of the results of irregular antibody screening with Surgiscreen (investigational reagent) and Serascan Diana 3 (control reagent), and the consistency of the results of irregular antibody screening with investigational reagent on serum and plasma from same patients.
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| Measure | Description | Time Frame |
|---|---|---|
| The consistency of the results of irregular antibody screening of investigational reagent and control reagent. | The positive coincidence rate, the negative coincidence rate and the overall coincidence rate, as well as their respective 95% confidence interval of the irregular antibody screening results of two reagents. | baseline |
| Measure | Description | Time Frame |
|---|---|---|
| The consistency of the results of irregular antibody screening with investigational reagent on different types of samples (serum and plasma). | The positive coincidence rate, the negative coincidence rate and the overall coincidence rate, as well as their respective 95% confidence interval of the irregular antibody screening results of investigational reagent on serum and plasma from same patient. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who need transfusion therapy in investigator sites.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Institute & Hospital, Chinese Academy of Medical Science | Beijing | Beijing Municipality | 100021 | China | ||
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Plasma or Serum left after routine clinical testing.
| baseline |
| Peking University First Hospital |
| Beijing |
| Beijing Municipality |
| 100034 |
| China |
| Shanghai Changzheng Hospital | Shanghai | Shanghai Municipality | 200003 | China |
| Shanghai Blood Center | Shanghai | Shanghai Municipality | 200051 | China |