TEST COBAS B 101 HBA1C 10 DISCS/BOX – Roche Diagnostics

TEST COBAS B 101 HbA1c 10 Discs/Box – Roche Diagnostics

The TEST COBAS B 101 HbA1c 10 Discs/Box from Roche Diagnostics is a dedicated consumable designed for use with the cobas b 101 system. These single-use test discs support in vitro diagnostic testing for glycated hemoglobin (HbA1c), a widely used marker of long-term glycemic status. Supplied as a convenient 10-disc box, the product is intended to help healthcare professionals perform HbA1c testing in settings where streamlined operation and standardized handling are important, including physician offices, outpatient clinics, and other point-of-care environments using the compatible cobas b 101 analyzer.

Intended use

HbA1c measurement is commonly used to monitor glycemic control over time and to support clinical decision-making in patients with diabetes. The cobas b 101 HbA1c test disc is designed to be used according to the analyzer’s instructions for use and the applicable local regulatory requirements. Results should be interpreted in the context of the patient’s overall clinical presentation, including symptoms, medical history, and other laboratory findings.

Compatibility

This product is specifically manufactured for the cobas b 101 system. Use with other analyzers or platforms is not supported. Using the correct disc type for the intended assay helps ensure that the analyzer can identify the test, perform the appropriate measurement sequence, and report the corresponding result parameters as configured by the system software.

Key product characteristics

• Single-use disc format: Each disc is intended for one patient test to reduce carryover concerns and simplify handling.
• Standardized consumable: Factory-prepared components within the disc support consistent test execution when used as directed.
• Convenient pack size: 10 discs per box supports smaller-volume workflows and inventory rotation.
• Designed for point-of-care workflow: Supports on-site testing with the cobas b 101 analyzer in appropriate clinical environments.

Typical workflow (overview)

1. Prepare the cobas b 101 analyzer and verify it is ready for testing.
2. Collect the patient sample using the sample type specified in the assay instructions.
3. Open the test disc packaging as directed and load the disc into the analyzer.
4. Follow the on-screen prompts to complete the measurement run.
5. Review and document the reported HbA1c result according to local procedures.

What’s included

• 10 x cobas b 101 HbA1c test discs (single-use)
• Manufacturer labeling and product identification information

Handling and storage

Store and handle the discs exactly as described by Roche Diagnostics in the product labeling and the cobas b 101 assay instructions. Keep discs in their original packaging until use, observe expiration dating, and avoid using damaged or improperly stored items. Good inventory practices—such as first-expired, first-out (FEFO)—help maintain test readiness and support reliable operation.

Quality and clinical use considerations

For best performance, follow established quality procedures for point-of-care testing, including operator training, routine maintenance of the analyzer, and any quality control or verification steps recommended by the manufacturer and required by local policy. If results appear inconsistent with the clinical picture, repeat testing or confirm with an alternative method as appropriate.