Staff at Catachem have been pioneers in the early development of diagnostic reagents for use on automated equipment going back to the 1970s, and the company continues to develop research versions of new reagents for future use in the human clinical laboratory.
Catachem’s DiscretPak™ products for human use have been evolving for the more than 30 years that the company has been in business. The majority of this reagent line is FDA 510K approved for use in the human laboratory. Landmark papers by Catachem’s founder, Luis P. Leon, on a UV glucose reagent have been cited 43 times, while research on a colorimetric version of this reagent have been cited 17 times as of January 2014. Some newer products, currently approved for research use only, include a plasma free hemoglobin (PFH) reagent that has been designed for use on a standard format clinical analyzer and a liquid ethylene glycol reagent for similar wet chemistry application.
Specialty Human Products
Normal plasma should not contain free hemoglobin. If blood is taken from a patient and is processed or manipulated in any way (dialysis, heart pump, etc.), or if the patient has suffered intravascular hemolysis caused by a number of disease states, damage to the red blood cells will be evident as hemoglobin released into the plasma. Catachem has developed an extremely sensitive assay to accurately measure minimal amounts of hemoglobin that may be present in a plasma sample.
This test can be run on most clinical chemistry analyzers, unlike those in the past. The test is sensitive and accurate enough to measure hemoglobin at levels approaching 2 mg/dL (1.2 µmol/L) and demonstrates linearity on most analyzers to 100 mg/dL (60 µmol/L).
Ethylene glycol is a key component in most antifreeze products. The ingestion of ethylene glycol can quickly poison the patient and lead to irreversible liver and kidney damage if not quickly diagnosed and treated. If ethylene glycol is shown to be present in a patient’s blood, treatment is relatively simple.
Catachem has developed an accurate quantitative test (C504-0A) that determines ethylene glycol levels. Values obtained on Catachem’s quantitative test reagent compare closely to values obtained on GC/MS methods (Am.J.Clin.Pathol. 2011, 136:165-6). Catachem’s product has been designed to effectively eliminate interferences from propylene glycol, a secondary component in some antifreeze products that is also used as an additive in some human foodstuffs.
NOTE: Neither diethylene glycol nor the antidote 4-methylpyrazole (fomepizole), the latter tested to a level of 3,000 mg/dL (30 g/L), showed any interference in the assay.
Clinically diagnosing methanol poisoning has been challenging to do, since it usually requires the use of specialized GC equipment not always available in a clinical laboratory. Severe methanol intoxication can be fatal. Catachem’s methanol test reagent can be used on a regular clinical chemistry analyzer.
This test is linear to 100 mg/dL (31 mM/L) and shows no interference from ethanol to a concentration of 690 mg/dL (a human being is comatose at 400 mg/dL ethanol). A 29 sample correlation against a GC-FID method gave a Deming Regression equation of y=0.899x – 2.66, r = 0.982.
This test is designed for the low-volume user for use on a simple spectrophotometer (340 nm wavelength). It provides three semi-quantitative tests, each with low and high controls. Every kit is designed for one-time use directly off the shelf with a shelf life of approximately 18 months.
Mirroring Catachem’s quantitative test formulation, it is not subject to common interferences like propylene glycol. The format of the kit involving the use of both low and high controls during each test run eliminates any need for additional calibration.
Designed similarly to Catachem’s FasTox ethylene glycol test for the low-volume user, this 340 nm test for methanol is for use on a simple spectrophotometer. Three individual tests are packaged along with three low and three high controls, eliminating the need for additional calibration. This product has an 18-month shelf life.
*For research use only