Evaluating HIV POC Kits with Positive/Negative Quality Controls

Each POC test site should always have two vials of quality control material available: one positive and one negative. These controls are ordered through the HIV Rapid Test Program Inventory Management portal. The controls are used to ensure that the testing kits used at your site are working properly.

Note that the positive control is only weakly reactive. This is done deliberately so that a reactive test demonstrates that the kits at your site are working in an optimal way.

Controls may be kept frozen or refrigerated for up to a year. Controls are shipped frozen, but, If they arrive thawed, they can be refrozen immediately or refrigerated. Regardless of the means of storage, they must be used before the expiry date on the package.

Quality control testing should be done regularly as follows:

  • When the kits are first received before any kits are used (this is sometimes referred to as validating the kits)
  • If a temperature reading is recorded outside the 2-30°C range
  • Monthly on existing kits or after every 125 tests completed (not more than once a week for high-volume sites)

Sites should establish procedures for regular quality control testing. Ideally, multiple staff take a part in the quality control process so that this knowledge is not restricted only to the quality assurance lead. The staff training module, Quality Assurance and Inventory Management, describes how to conduct quality control testing and how to follow-up on unexpected results. Bulb pipettes provided by the AIDS and Hepatitis C Program for this testing.

A template is available to record the outcomes of quality control testing.

Note: If a site has multiple sub-locations, the main sites is responsible for ordering an adequate supply of quality controls and distributing them among the sub-locations. Each sub-location must conduct quality control testing on their supply of kits, as outlined above.