Abbott BinaxNOW™ 9x Malaria Positive Controls

The product at a glance

• Quality control for the BinaxNOW Malaria Test
• Simple application with negative blood sample
• Confirms correct function of reagents and test procedure
• Ideal for training new users and routine control
• Positive result guarantees correct test outcomes
• Supports efficient workflows and ensures quality

An external quality control for the BinaxNOW Malaria Test is offered by the BinaxNOW Positive Control. It supports dependable quality control in conjunction with patient testing by assisting in confirming that the test reagents and process are operating as intended.

Reconstitute the lyophilised material with deionised water and combine it with a pool of blood that is free of malaria in order to employ the control. Next, carry out the test in accordance with standard protocol. A positive result for all malaria species and Plasmodium falciparum (HRP II) on both test strips indicates that the test is operating as intended.

New users can also benefit from using the positive control as a teaching tool to familiarise themselves with the test process and identify possible mistakes early on.

The control should be kept between 2 and 8 °C. Reconstituted aliquots can be frozen, which helps to maximise the use of the control material and offers flexibility for regular quality monitoring.

Specifications

• Product type: External positive quality control for the BinaxNOW Malaria Test
• Contents:
  1. Lyophilised control with recombinant antigen (HRP II and universal malaria protein)
  2. Cryovials with caps and cardboard stand for aliquoting and storage
• Intended use: Verification of the proper functioning of the test reagents and test procedure
• Reconstitution: With deionised water
• Application: Mixing with negative human EDTA whole blood before test execution
• Storage:
  1. Lyophilised: 2–8 °C in foil pouch
  2. Reconstituted: Frozen (≤ -20 °C) in cryovials
• Shelf life: Until the expiry date indicated on the packaging when storage conditions are observed
• Test result: Positive on both test strips (P. falciparum-specific and all malaria species)
• Quality control: Recommended with each new delivery or batch and prior to first use by new users
• Scope of use: Professional use in medical laboratories
• Special features: Contains sodium azide as a preservative

Usage Tips

• Reconstitute lyophilised positive control with deionised water
• Mix reconstituted control with a pool of malaria-negative EDTA whole blood
• Use positive control as a patient sample in the BinaxNOW Malaria Test
• Read results after 15 minutes:
  1. Positive if control line (C) and test lines (T1 and T2) are visible
  2. Invalid if control line (C) is missing or background discoloration prevents reading
• Use control regularly:
  1. With every new test kit delivery or batch
  2. Before first use by new staff
• Aliquot after reconstitution and store at ≤ -20 °C to extend shelf life
• In case of unexpected results, repeat test or contact technical customer service

Technical Specifications

• Product name: BinaxNOW™ Positive Control
• Contents: Lyophilised recombinant antigen control (HRP II and universal malaria protein)
• Packaging: Cryovials with caps, cardboard stand for aliquoting and storage
• Storage lyophilised: 2–8 °C
• Storage reconstituted: Frozen at ≤ -20 °C
• Shelf life: According to expiry date on the packaging
• Reconstitution: With deionised water
• Application: Mixing with malaria-negative EDTA whole blood before test execution
• Test result: Positive on both test strips (P. falciparum-specific and all malaria species)
• Preservative: Sodium azide
• Scope of use: Professional use in medical laboratories
• Cryovial dimensions: Standard size (not specified)
• Weight: Not specified
• Certification: Approved for professional use

Delivery

• 9x BinaxNOW Malaria Positive Control