BIOtAK launches enzyme-based washing efficacy indicators

The tests provide CSSD managers and operators cleaning surgical instruments with fast results

UK-based company BIOtAK is launching two new enzyme-based washing efficacy indicators for sectors where disinfection and sterilisation processes are operating. The products WASHtAK and LUMENtAK, will be on show along with a new assurance monitoring system at MEDICA, in Düsseldorf, Germany, this November.

The company says WASHtAK is a fast, easy-to-use and highly sensitive enzyme-based washing efficacy indicator that delivers quantifiable and objective results in an area where, until now, only subjective, insensitive, slow or qualitative tests have been available.

The indicator is designed to give CSSD managers and operators the ability to manage, monitor and optimise their wash process. This is achieved through the use of patented tAK technology, combined with a highly sensitive and advanced reading system.

There are three elements to the test: The test strip in its holder, the test tube with its reagents, and the handheld reader.

The test strip is made of plastic and has a small line of tAK enzyme at one end of the strip. It comes assembled in a holding device which has been designed by BIOtAK specifically for the WASHtAK product. This holder has specific features to ensure that the test is realistic, cannot be tampered with, and that the strip can be dispensed into the test tube without being handled, that it can be secured to a DIN basket or other carrier, and that track and trace information is clearly presented. Each test strip in its holder is individually packaged into a sterile pouch.

The test tube consists of a tube and a cap, which contains the reagents. There are two reagents needed for this test, both of which are kept separately in the cap. The reagents are released via a snap mechanism to pour them onto the test strip in the tube. The reagents react with the tAk that remains on the strip to produce a bioluminescent signal which is read by the handheld reader.

The handheld reader reads the bioluminescence emitted in the reaction between the tAK and the two reagents, and is displayed as a numeric value.

A test device is put in with a wash on the dirty side and retrieved after the wash on the clean side of a washer disinfector. The test strip is then dispensed into the test tube. Following this the reagents are introduced. The test tube is then put into to the reader to take a reading. After 30 seconds reaction time, the reading is displayed. The more tAK that remains on the test strip the more light will be emitted in the reaction, so the higher the reading the worse the wash process, and vice versa.

Using exactly the same test strips but in a different test device LUMENtAK does for lumen washing what WASHtAK does for the washing of the outside of surgical instruments, i.e. provide the user with a quantifiable, objective, and sensitive means by which to manage, monitor and optimise their wash process.

BIOtAK says a WASHtAK test can be performed within two minutes. The tests are also said to be up to 10,000 times more sensitive than alternative protein measurement tests.