OraQuick Rapid HCV Test Kit Visual Reference Panel

The OraQuick Rapid HCV Test Kit Visual Reference Panel is designed to provide established visual benchmarks for interpreting the results of the OraQuick Rapid HCV Test. It serves as a crucial quality assurance tool, helping users validate the correct reading of test outcomes.

The panel includes three distinct reference devices that cover the entire testing spectrum:

• One HCV Limit of Detection device (to confirm the lowest detectable level)
• One HCV low reactive device
• One HCV Non-Reactive device (negative benchmark)

This comprehensive set ensures accuracy and consistency when validating interpretation accuracy.

The OraQuick Rapid HCV Test Kit Visual Reference Panel includes a comprehensive set of three reference devices designed to establish visual benchmarks for accurate result interpretation. These devices are crucial for quality control and training.

The panel components included are:

• HCV Limit of Detection Device (1): Used to verify the lowest concentration the test can reliably detect.
• HCV Low Reactive Device (1): Provides a definitive visual reference for results near the positive cutoff.
• HCV Non-Reactive Device (1): Serves as a definitive negative control, crucial for validating non-reactive results.

The OraQuick Rapid HCV Test Kit provides results very quickly, which is one of its top selling points. The key time specifications are:

• Time to Results: Results are available in as little as 20 minutes.
• Read Window: The official test interpretation window is between 20 and 40 minutes.

Yes, the test this reference panel supports is compatible with two flexible types of whole blood samples, making it suitable for various clinical settings: * Fingerstick whole blood * Venipuncture whole blood The overall testing procedure is classified as CLIA Waived.

The OraQuick Rapid HCV Test Kit Visual Reference Panel is designed for longevity and quality assurance. It provides an established shelf life of 18 months from the date of manufacture. This ensures the reliability of the three included reference devices (Limit of Detection, low reactive, and non-reactive) over an extended period.

The OraQuick Rapid HCV Test Kit Visual Reference Panel requires strict temperature control to ensure device performance and integrity. You must store the panel between 2° C and 30° C (36° F and 86° F).

The OraQuick Rapid HCV Test Kit should be operated within the temperature range of 15° C to 37° C (59° F to 99° F). Adhering to this specific range is essential to ensure the accuracy and reliability of the test results.

The OraQuick Rapid HCV Test Kit utilizes the Lateral Flow test method. This methodology is designed to provide rapid diagnostic results, with test readings available in as little as 20 minutes.

Yes, comprehensive controls are included to ensure the reliability and accuracy of the OraQuick Rapid HCV Test Kit. The test system incorporates both internal and external controls for quality assurance:

• External Controls: Positive and negative controls are utilized.
• Internal Control: An IgG specific internal control is used.

Additionally, the Visual Reference Panel itself is composed of three specific reference devices intended for visual verification:

• HCV Limit of Detection (1 device)
• HCV Low Reactive (1 device)
• HCV Non-Reactive (1 device)

Yes, the OraQuick Rapid HCV Test Kit Visual Reference Panel is classified as CLIA Waived. This designation simplifies regulatory requirements, making the device suitable for use in a wide variety of clinical and laboratory settings.