- Condition: Factory New
- Country of Origin: USA
- Warranty: Until Use/Expiration
- Weight: 0.34 lb
- Results are ready in as little as 20 minutes
- Fingerstick whole blood and venipuncture whole blood
- CLIA waived
- 18 month shelf life
- MFR: OraSure Ships from Manufacturer
- MPN: 1001-0343
- Phone: (800) 672-7873
Buying OraQuick Rapid HCV Test Kit Visual Reference Panel from MFI Medical
Product details
- Category
- Antibody Tests
- Manufacturer part number
- 1001-0343
- MFI SKU
- OST-1001-0343
- Results are ready in as little as 20 minutes
- Fingerstick whole blood and venipuncture whole blood
- CLIA waived
- 18 month shelf life
Supplier, condition & warranty
- Supplier
- MFI Medical Equipment, Inc.
- Brand
- OraSure
- Condition
- Factory New
- Listed warranty
- Until Use/Expiration
MFI Medical is an authorized distributor for all new OraSure items we sell. Any included warranty on a new item is provided directly by the manufacturer. MFI Medical is available to assist with manufacturer warranty claims.
Healthcare purchasing support: MFI Medical provides formal quotations, accepts purchase orders, and offers payment terms to approved customers. W-9 and vendor onboarding information and purchase order and payment instructions are available online.
Purchasing and warranty assistance: MFI Medical: (800) 633-1558. Contact MFI Medical · Warranty policy. Manufacturer product support: (800) 672-7873.
Price & shipping
| MPN | Condition & warranty | Item price (USD) |
|---|---|---|
| 1001-0343MFI SKU: OST-1001-0343Barcode: 41116145 | Factory NewWarranty: Until Use/Expiration | $89.79 Free shipping* |
*Free standard shipping to the contiguous U.S. on eligible orders of US$35 or more. Other destinations and upgraded services cost extra. Shipping policy
Frequently asked questions
What comprehensive reference devices are included?
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.
Does it use fingerstick and venipuncture blood samples?
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.
Are internal and external controls included?
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)
Is this reference panel CLIA Waived?
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.
Does this test provide rapid results?
Yes, the OraQuick Rapid HCV Test provides results quickly:
- Time to Results: Test results are available in as little as 20 minutes.
- Read Window: The designated window for accurate interpretation of the test is between 20 and 40 minutes.
How does the Visual Reference Panel assist with test interpretation?
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.
How fast are the rapid HCV 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.
Does the reference panel have an 18-month shelf life?
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.
What is the rapid test method used?
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.
How does the visual reference panel help with test interpretation?
The OraQuick Rapid HCV Test Kit Visual Reference Panel is designed for use as a visual guide when interpreting results from the OraQuick Rapid HCV test. It helps users accurately differentiate between HCV Limit of Detection, HCV low reactive, and HCV Non-Reactive outcomes.