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Description

OraQuick Rapid HCV Test Kit Controls include an HCV Positive Control (1 vial, purple cap, 0.2 mL), an HCV Negative Control (1 vial, white cap, 0.2 mL), and a package insert.

Specifications

OraQuick Rapid HCV Test Kit Controls Specifications

  • Time to Results: 20 minutes.
  • Test Read Window: 20-40 minutes.
  • Sample Type: Fingerstick whole blood and venipuncture whole blood.
  • CLIA Complexity: Waived.
  • External Controls: Positive and negative.
  • Internal Control: IgG specific.
  • Storage Requirements: 2-30° C (36-86° F).
  • Operating Requirements: 15-37° C (59-99° F).
  • Method: Lateral Flow.
  • Device Shelf Life: 18 months from date of manufacture.
  • CPT Code: 86803 (CPT code) / G0472 (HCPCS).

Frequently asked questions

How quickly do the OraQuick Rapid HCV Test Kit Controls provide results?

The OraQuick Rapid HCV Test Kit Controls provide results in just 20 minutes, allowing for quick verification of testing procedures.

Can this test kit control be used with both fingerstick and venipuncture whole blood samples?

Yes, the OraQuick Rapid HCV Test Kit Controls can be used with both fingerstick and venipuncture whole blood samples, offering flexibility in testing methodologies.

Is this test kit control CLIA waived?

The OraQuick Rapid HCV Test Kit Controls are CLIA waived, which simplifies the implementation of quality control in various testing settings.

What is the test read window for this control kit?

The read window for the OraQuick Rapid HCV Test Kit Controls is 20-40 minutes after the control has been applied.

Which essential quality controls are provided?

The OraQuick Rapid HCV Test Kit Controls provide the necessary external materials for quality assurance and verification of the corresponding rapid HCV test kit.

The set includes:

  • HCV Positive Control (1 vial, 0.2 mL, identifiable by a purple cap)
  • HCV Negative Control (1 vial, 0.2 mL, identifiable by a white cap)
  • Package insert

These controls are designed to verify test accuracy and are compatible with both fingerstick whole blood and venipuncture whole blood samples.

What are the storage requirements for this control kit?

The OraQuick Rapid HCV Test Kit Controls should be stored between 2-30° C (36-86° F).

What are the operating temperature requirements for this control kit?

The OraQuick Rapid HCV Test Kit Controls should be operated between 15-37° C (59-99° F).

What is the shelf life of this control kit?

The OraQuick Rapid HCV Test Kit Controls have a device shelf life of 18 months from the date of manufacture.

Does the kit include positive and negative controls?

Yes, the kit includes a comprehensive set of external quality control materials essential for verifying the test kit’s accuracy:

  • HCV Positive Control (1 vial, purple cap, 0.2 mL)
  • HCV Negative Control (1 vial, white cap, 0.2 mL)

Additionally, the test features an IgG specific internal control to monitor the overall assay performance.

Does this control kit have an internal control?

Yes, the OraQuick Rapid HCV Test Kit Controls include an IgG specific internal control in addition to the positive and negative external controls.