| Product Name | AAV5 Antibody Companion Diagnostics (CDx) Device |
| Catalog No. | RDD-QCY-0001 |
| Description | The AAV5 antibody companion diagnostics device is a prescription companion diagnostic (CDx) test for detecting AAV5 antibodies in human plasma to assist in screening patients with hemophilia A. |
| Certification | FDA |
| Application | Used for detecting total antibodies (TAb) against AAV5 and evaluating the suitability of specific drugs for use in hemophilia A. |
| Sample Types | Plasma |
| Features | Specifically designed for patients with hemophilia A, this test is standardized and targeted. Utilizing advanced technology, it precisely detects AAV5 antibodies in human plasma, providing critical evidence for patient treatment. Strict requirements for sample collection and processing—such as using 3.2% sodium citrate tubes for blood collection and centrifuging plasma within 72 hours—ensure sample quality and operational safety. |
| Instructions for Use | Collect patient whole blood into a 3.2% sodium citrate blood collection tube. Centrifuge to separate plasma from cells within 72 hours after collection. Transfer 1 mL of plasma (minimum 0.5 mL) to a flip-top (transport) blood collection tube. Freeze the plasma sample at -10°C or lower. Place the frozen plasma sample on the device for testing. |
| Storage | Store in a cool, dry place at temperatures between 5°C and 30°C, away from direct sunlight. |
For in vitro diagnostic use.
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