• Convenient, easy-to-use
• Easily interpreted results
• Equivalent accuracy to many more complex tests
• Less labor intensive (lower total costs, lower error potential)
• No glass or metal sharps
• No mixing mess
• Easy storage
• Specifically designed for dialysis applications
• Reliable and consistent

Guidelines and Regulations
Prior to 1990, there were very few water quality, disinfectant potency or residual tests designed and tested specifically for dialysis. Additionally, knowledge on the effect of various water and dialysis system contaminants on the short and long term health of dialysis patients has evolved significantly in the past 20 years. Many of the critical standards and recommendations for the removal of harmful substances and organisms from critical water supplies and systems used to purify and deliver water and bicarbonate solutions can now be found in the current AAMI standards. (Association for the Advancement of Medical Instrumentation, Recommended Practice for Reuse of Hemodialyzers, 1993.) New and improved recommendations are continually being discussed and adopted. Visit the AAMI web site (www.aami.org) for the latest information.

Are You Using the Wrong Test?
As the adverse health impact of residual disinfectants and other contaminants were of great concern to dialysis caregivers, the best available tests were adopted to protect dialysis patients from exposure to harmful chemicals or pathogens. Some tests, such as the Limulus test for endotoxins, are effective and of suitable sensitivity. In some cases, generic chemical tests available for other analytical or diagnostic purposes were adopted by dialysis caregivers in an attempt to protect their patients from the toxic effects of residual disinfectants.

Two of the disinfectants traditionally used in dialysis are bleach (chlorine) or formaldehyde. In some cases, the "off-label" application of these tests is no longer appropriate and does not meet AAMI standards and guidelines. Additionally, recent FDA regulations have increased the level of in-house testing and quality assurance procedures needed to allow use of "off-label" or "home brew" tests in medical laboratories and facilities. The new rules on analyte specific reagents (ASRs) were published in the Federal Register (62243-62260) on Nov. 21, 1997. The rule is available on the Internet by directly accessing the AACC web site (www.aacc.org), then clicking on "government affairs," then "government links."

In the 1980’s three commercially available clinical tests had been widely adopted for use in dialysis. None of these tests have sufficient sensitivity to meet the current AAMI guidelines for maximum allowable residual levels of chlorine or formaldehyde.

Three Inappropriate Test:

1. Occult Hemoglobin Pads (Urine Strips)
   HemaStix (trademark of Bayer Corp.) has previously been reported¹ to be useful in determining residual chlorine (bleach) levels in dialyzer and dialysis system rinse procedures. HemaStix were reported to be only sensitive to 1.8-3.0 ppm or 4-6 times the AAMI recommended maximum of 0.5 ppm. Internal tests at Serim Research indicate HemaStix to be sensitive to only 3 to 5 ppm of chlorine. Variable results between lots are possible, as these tests are not checked with chlorine. All occult hemoglobin test pads will show similar results.
   1 Duarte RG. In vitro Sodium Hypochlorite Reductions. Dialysis & Transplantation, Vol. 17, No. 11,
   November 1988, p. 579-80
2. Starch (Potassium iodide paper)
   Starch paper is also used to determine residual chlorine concentrations. Internal Serim tests (data available on request from Serim) show that when using the typical dip-and-read test, starch paper is only sensitive to approximately 8 ppm or 16 times the AAMI maximum recommended level of 0.5 ppm. Lot-to-lot results may vary.
3. CliniTest Tablets (Trademark of Bayer Corp.)
   CliniTest Tablets for urine glucose testing have been used to test for residual formaldehyde levels. Serim internal test data (report available on request) have shown CliniTest tablets will react with low levels of formaldehyde. However, the sensitivity of CliniTest tablets is approximately 80-160 ppm or 16 to 32 times the AAMI recommended maximum of 5 ppm.

The Appropriate Dialysis Tests:
Serim Research Corporation is the leading supplier of 510(k)-cleared test kits specifically designed for dialysis use.

Serim Residual Chlorine Test Strips

• Meets AAMI standards of 0.5-ppm
• Easy-to-use, quick, simple to interpret
• Every lot tested with standards at levels appropriate for dialysis
• Expiration dates ensure products freshness

Available as:
      #5100, 5 bottles, 100 strips per bottle plus controls
      #5100C, 12 bottles, 25 strips per bottle

Serim Residual Formaldehyde Test Strips

• Meets AAMI standards of 5.0-ppm (and California standards of 3.0-ppm)
• Easy-to-use, quick, simple to interpret
• Every lot tested with standards at levels appropriate for dialysis
• Expiration dates ensure product freshness

Available as:
     #5111, 5 bottles, 50 strips per bottle plus controls
     #5112, 6 bottles, 100 strips per bottle