NEW GLOUCESTER, Maine--(BUSINESS WIRE)--Manufacturers and clinical laboratories are doing a reasonably good job assessing endogenous interferents that may alter lab test results. The next big hurdle is the assessment of interference from common drugs. There are literally hundreds of drugs in clinical use, both prescription and over-the-counter, which can vary widely in their blood and urine concentrations and which can introduce errors in laboratory testing. Which are the most important to test? An expert panel was convened to make specific recommendations concerning the drugs and concentrations that should be assessed when validating laboratory tests.1
Preparing concentrated drug solutions for interference testing has been labor intensive and expensive - until now. Sun Diagnostics now offers ASSURANCE™ DRUG Interference Test Kit for Laboratory Use as part of interference testing procedures. Interferents available include: ACETAMINOPHEN, N-ACETYLCYSTEINE, ACETYLSALICYLIC ACID, AMPICILLIN SODIUM, CEFOXITIN SODIUM, CYCLOSPORINE, DOXYCYCLINE HCL, HEPARIN, IBUPROFEN, LEVODOPA, METHYLDOPA, METRONIDAZOLE, PHENYLBUTAZONE, RIFAMPICIN, and THEOPHYLLINE. Components may be purchased individually, in customer-defined combinations, or as INT-04 (one vial of each component).
Drug components and concentrations are based on recommendations by the expert panel1 and the Clinical Laboratory Standards Institute (CLSI).2 The concentrations are 20 times the recommended test concentrations, allowing a 1:20 dilution with serum/urine pool. Drugs included are acetylcysteine, ampicillin Na, cefoxitin Na, doxycycline HCl, theophylline, levodopa, methyldopa, metronidazole, acetylsalicylic acid, ibuprofen, phenylbutazone, rifampicin, cyclosporine, acetaminophen and heparin, all at 20X concentrations.
|ACETYLCYSTEINE||204 mmol/L||ACETYLSALICYLIC ACID||72.4 mmol/L|
|AMPICILLIN NA||3,040 µmol/L||IBUPROFEN||48,5000 µmol/L|
|CEFOXITIN NA||30,920 µmol||PHENYLBUTAZONE||8,000 mg/L|
|DOXYCYCLINE HCL||1,350 µmol/L||RIFAMPICIN||1,562 µmol/L|
|THEOPHYLLINE||4,440 µmol/L||CYCLOSPORINE||100 mg/L|
|LEVODOPA||400 mg/L||ACETAMINOPHEN||26,480 µmol/L|
|METHYLDOPA||400 mg/L||HEPARIN||60,000 U/L|
|METRONIDAZOLE||14,020 µmol/L||Ethanol is also included to be used in preparation of control pool for ethanolic interferents.|
1Sonntag O, Scholer A. Drug interference in clinical chemistry: recommendations of drugs and their concentrations to be used in drug interference studies. Ann Clin Biochem 2001; 38:376-385.
2Clinical and Laboratory Standards Institute (CLSI). Interference Testing in Clinical Chemistry; Approved Guideline ̶ Second Edition. CLSI document EP7-A2 (ISBN 1-56238-584-4). Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2005.
About Sun Diagnostics, LLC
Sun Diagnostics, LLC, located in New Gloucester, Maine focuses on innovative products that meet the needs of patients, clinicians, laboratories, and researchers.
Sun Diagnostics simplifies interference testing with the ASSURANCE™ product line. ASSURANCE™ interferents are high quality, highly concentrated materials from human sources (where possible) or purified chemicals, and are available as kits or individual vials to best match users’ needs. Available interferents: triglyceride-rich lipoproteins, hemolysate, protein, bilirubin, rheumatoid factor, acetylcysteine, ampicillin Na, cefoxitin Na, doxycycline HCl, theophylline, levodopa, methyldopa, metronidazole, acetylsalicylic acid, ibuprofen, phenylbutazone, rifampicin, cyclosporine, acetaminophen and heparin.