Roche Chemstrip Urinalysis Products

The comprehensive 10-parameter strips, such as the Chemstrip 10SG, perform semi-quantitative analysis for ten crucial urinary analytes. It is important to note that many configurations, including the 10SG strips, are CLIA Waived, making them ideal for rapid, reliable results in point-of-care environments.

The analytes detected are:

• Specific Gravity (SG)
• pH
• Leukocytes
• Nitrite
• Protein
• Glucose
• Ketone
• Urobilinogen
• Bilirubin
• Blood (Hemoglobin/Erythrocytes)

Yes, calibration strips for the Roche Chemstrip system are available and are crucial for maintaining the accuracy and proper functioning of associated instruments, such as the Urisys 1100.

You can obtain them in two ways:

• As a separate variant: Calibration strips are offered as an individual product configuration.
• In the Starter Kit: One vial of calibration strips is included when purchasing the comprehensive 10 MD Starter Kit, which bundles the strips with the Urisys 1100 Instrument Kit.

The Roche Chemstrip line includes blood (Erythrocytes/Hemoglobin) detection in several comprehensive configurations.

Specific test strip configurations that include blood detection are:

• Chemstrip 5 OB (5 parameters, often used in obstetric applications)
• Chemstrip 9 (9 parameters)
• Chemstrip 10SG (10 parameters, including Specific Gravity)
• Chemstrip 10 MD (10 parameters)

For example, the comprehensive Chemstrip 9 panel detects blood alongside Leukocytes, Nitrite, pH, Protein, Glucose, Ketones, Urobilinogen, and Bilirubin.

Yes, most configurations of the Roche Chemstrip Urinalysis Products are designated as CLIA Waived.

This CLIA Waived status is a key benefit, as it simplifies regulatory requirements for testing. This makes the strips broadly accessible and suitable for use in various settings, including clinical laboratories, medical offices, and point-of-care facilities.

These products are intended specifically for In Vitro Diagnostic Use.

To ensure the accuracy and reliability of the Chemstrip urinalysis products, proper storage conditions must be followed:

• Temperature: Store the test strips between 2°C (36°F) and 30°C (86°F). It is critical not to freeze the strips.
• Vial Care: Keep the vial tightly closed when not in use.

Note: Specific variants, such as the specialized Micral strips, have additional requirements and are noted to ship on ice.

The quantity of test strips per vial varies by configuration:

• Most test strip configurations, such as the 10SG variant, come with 100 strips per vial.
• Specialized variants like the Micral strips are available in vials containing 30 strips.

Additionally, the 10 MD Starter Kit includes six vials of Chemstrip 10 MD strips and a vial of calibration strips, along with the Urisys 1100 Instrument and other components.

Yes, the Roche Chemstrip products are specifically designed for professional in vitro diagnostic use and are highly suitable for various clinical and point-of-care environments. They offer reliability and compliance essential for medical settings.

Key features supporting their clinical suitability include:

• CLIA Waived Status: Most configurations of these strips are CLIA Waived, simplifying regulatory requirements for testing in settings such as physician offices and non-laboratory facilities.
• Trusted Manufacturer: These products are manufactured by Roche Diagnostics Corp., a recognized provider of high-quality diagnostic products.
• Versatile Testing: The product line offers configurations ranging from simple 2-parameter strips (Glucose/Protein) up to comprehensive 10-parameter panels, covering vital parameters like Specific Gravity, pH, Leukocytes, Nitrite, and more.
• Starter Kit Availability: A complete 10 MD Starter Kit is available, which includes the Urisys 1100 Instrument Kit, calibration strips, and multiple vials of test strips for immediate setup of a complete urinalysis testing station.

The 10 MD Starter Kit is a comprehensive package designed for establishing a CLIA Waived urinalysis testing station, integrating with automated reading systems (like the Urisys 1100). This option is tailored for immediate, high-volume diagnostic use.

The complete kit includes:

• 1 Urisys 1100 Instrument Kit: The necessary device for automated strip analysis.
• 6 vials Chemstrip 10 MD Urine Test Strips: To provide a substantial supply of 10-parameter tests.
• 1 vial Calibration strips: Essential for maintaining the instrument’s accuracy.
• Operators Manual
• Training CD
• Quick Reference Guide & Set-Up Instructions

Yes, these Roche Chemstrips are designed for rapid and reliable detection in in vitro diagnostic use, which supports timely screening and diagnosis.

They allow medical professionals to quickly analyze urine samples for up to 10 parameters, aiding in the monitoring of conditions such as diabetes, kidney function, and urinary tract infections (UTIs).

Key benefits include:

• Timely Results: Facilitate quick clinical decisions.
• Ease of Use: Most configurations are CLIA Waived, simplifying regulatory requirements for testing environments.

Yes, the Roche Chemstrip Urinalysis Products are designed for reliable results, backed by stringent manufacturing and regulatory standards.

Key features that confirm their reliability and utility include:

• Trusted Manufacturer: Manufactured by Roche Diagnostics Corp. specifically for professional In Vitro Diagnostic Use.
• Regulatory Compliance: Most configurations are CLIA Waived, which simplifies regulatory requirements while maintaining high testing standards.
• Optimal Condition: All products are supplied as Factory New, guaranteeing the integrity and optimal performance of the diagnostic reagents.
• Versatile Testing: The strips offer reliable results across various diagnostic needs, with configurations available for 2, 5, 7, 9, or 10 parameters, including Specific Gravity, Glucose, Protein, and pH.