OraSure OraQuick ADVANCE Rapid HIV-1/2 Test Kit Controls

OraSure OraQuick ADVANCE Rapid HIV-1/2 Test Kit Controls
Key Features
  • SKU: OST-1001-0077
  • Condition: Factory New
  • Country of Origin: USA
  • Warranty: Until Use/Expiration
  • Weight: 0.05 lb
  • Requires refrigeration. Store the controls at a temperature between 2 and 8 °C (35 and 46 °F)
  • The black-capped vial contains 0.2 mL of photochemically inactivated human plasma positive for HIV-1 antibodies that have been diluted in a defibrinated pool of normal human plasma
  • The red-capped vial contains 0.2 mL of photochemically inactivated human plasma positive for HIV-2 antibodies that have been diluted in a defibrinated pool of normal human plasma
  • The white-capped vial contains 0.2 mL of photochemically inactivated human plasma negative for HIV-1 and HIV-2 antibodies
  • This item is non-returnable

  • Learn more:

Contact The Manufacturer
  • MFR: OraSure Ships from Manufacturer
  • MPN: 1001-0077
  • Phone: (800) 672-7873
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Description

The OraSure OraQuick ADVANCE Rapid HIV-1/2 Test Kit Controls (#1001-0077) include a package insert and three vials - an HIV-1 positive control, HIV-2 positive control, and negative control.

Note: This Controls Kit does not include an HIV Test.

Warranty: Until Use or Expiration (Two Year Shelf Life from the date of purchase).

Specially designed to ensure performance of the OraSure OraQuick ADVANCE Rapid HIV Test Kit, the OraQuick ADVANCE Controls features three quality control reagents that require refrigeration and should be stored between 2 and 8 °C (35 and 46 °F).

Run the Kit Controls under the following circumstances:

  • Each new operator prior to performing testing on patient specimens.
  • When opening a new test kit lot.
  • Whenever a new shipment of test kits is received.
  • If the temperature of the test kit storage area falls outside of 2 to 27 °C (36 to 80 °F).
  • If the temperature of the testing area falls outside of 15 to 37 °C (59 to 99 °F).
  • At periodic intervals as dictated by the user facility.

Features

OraSure OraQuick ADVANCE Rapid HIV-1/2 Test Kit Controls Features

  • Requires refrigeration. Store the controls at a temperature between 2 and 8 °C (35 and 46 °F).
  • The black-capped vial contains 0.2 mL of photochemically inactivated human plasma positive for HIV-1 antibodies that have been diluted in a defibrinated pool of normal human plasma.
  • The red-capped vial contains 0.2 mL of photochemically inactivated human plasma positive for HIV-2 antibodies that have been diluted in a defibrinated pool of normal human plasma.
  • The white-capped vial contains 0.2 mL of photochemically inactivated human plasma negative for HIV-1 and HIV-2 antibodies.

Frequently asked questions

What is the purpose of the OraSure OraQuick ADVANCE Rapid HIV-1/2 Test Kit Controls?

The OraSure OraQuick ADVANCE Rapid HIV-1/2 Test Kit Controls are designed to validate the performance of the OraQuick ADVANCE Rapid HIV Test Kit, ensuring accurate and reliable HIV testing. They provide quality control reagents to verify test results.

Which specific control reagents are included?

The kit includes a comprehensive set of three distinct quality control reagents necessary for verifying the performance of the OraQuick ADVANCE Rapid HIV-1/2 Test Kit. Each control vial contains 0.2 mL of photochemically inactivated human plasma.

The contents are clearly color-coded for identification:

  • HIV-1 Positive Control: Identified by the Black Cap.
  • HIV-2 Positive Control: Identified by the Red Cap.
  • Negative Control: Identified by the White Cap.
Do the high-quality controls require refrigeration?

Yes, these controls absolutely require refrigeration to maintain reagent integrity and ensure the reliable performance validation of the OraQuick ADVANCE Test Kit. Failure to comply could compromise test validity. The mandatory storage temperature range is:

  • 2 to 8 °C (35 to 46 °F)
What volume of control solution is included?

Each of the three distinct control vials (HIV-1 positive, HIV-2 positive, and negative) contains 0.2 mL of solution. This precise amount ensures standardized testing when validating the performance of the OraQuick ADVANCE Rapid HIV Test Kit. The control solution itself is composed of photochemically inactivated human plasma.

What materials make up the positive controls?

The positive control reagents are specifically formulated using human plasma:

  • HIV-1 Positive Control (Black Cap): Contains 0.2 mL of photochemically inactivated human plasma positive for HIV-1 antibodies, diluted in a defibrinated pool of normal human plasma.
  • HIV-2 Positive Control (Red Cap): Contains 0.2 mL of photochemically inactivated human plasma positive for HIV-2 antibodies, diluted in a defibrinated pool of normal human plasma.
What is in the negative control vial?

The negative control, which is sealed with a white cap, contains 0.2 mL of photochemically inactivated human plasma. This plasma is confirmed to be negative for both HIV-1 and HIV-2 antibodies, making it essential for validating that the OraQuick ADVANCE Test Kit yields an accurate negative result.

Where are these test kit controls manufactured?

The OraSure OraQuick ADVANCE Rapid HIV-1/2 Test Kit Controls are proudly made in the USA.

How do these controls ensure diagnostic test quality?

These controls are essential for rigorously validating the performance of the OraQuick ADVANCE Rapid HIV-1/2 Test Kit, ensuring reliable results by confirming the integrity of your testing system. The set includes three specialized, photochemically inactivated human plasma reagents:

  • HIV-1 Positive Control (Black cap): Verifies the test’s capability to detect HIV-1 antibodies.
  • HIV-2 Positive Control (Red cap): Verifies the test’s capability to detect HIV-2 antibodies.
  • Negative Control (White cap): Confirms the test’s specificity to help prevent false-positive readings.

Regular use of these controls is a critical component of laboratory compliance and diagnostic accuracy. They are required for:

  • New Operators: To validate proficiency in testing procedures.
  • New Test Lots: To verify the integrity of new kit shipments upon receipt.
  • Routine Quality Assurance: To maintain adherence to standard operating procedures and identify any issues with test reagents or storage conditions.

For optimal results, please ensure these vials are stored refrigerated at 2 to 8 °C (35 to 46 °F).

When should these essential quality controls be used?

The OraQuick ADVANCE Rapid HIV-1/2 Test Kit Controls are vital for ensuring the accuracy and reliability of your diagnostic testing system. They should be utilized to maintain laboratory compliance in the following scenarios:

  • New Operator Training: To validate proficiency when new staff begin performing tests.
  • New Lot Verification: Each time a new test kit lot is introduced.
  • New Shipment Arrival: Upon the receipt of new shipments.
  • Environmental Monitoring: Following significant shifts in storage or testing temperatures.
  • Routine Protocols: At periodic intervals as defined by your facility’s standard operating procedures.

Please note that these controls must be stored refrigerated between 2 and 8 °C (35 and 46 °F) to maintain their integrity.

Are these controls required for new operator training?

Yes, these quality control reagents are essential for training new operators on the OraQuick ADVANCE Rapid HIV-1/2 Test Kit and verifying the system’s performance before any patient testing occurs.

Performing control runs is a critical step to ensure system validity and laboratory compliance in the following situations:

  • New Operator Training: To verify the proficiency of anyone new to performing the test.
  • New Shipments and Lots: When opening a new test kit lot or receiving new inventory.
  • Environmental Changes: Following significant shifts in storage or testing temperatures, or at periodic intervals as defined by your facility’s protocols.

The kit comes with three color-coded vials for easy identification:

  • Black Cap: HIV-1 Positive Control
  • Red Cap: HIV-2 Positive Control
  • White Cap: Negative Control