Human Diagnostics – Overview

Staff at Catachem Inc. were pioneers in the early development of diagnostic reagents for use on automated equipment in the seventies 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 evolved over the thirty years that Catachem Inc. has been in business and the majority of this reagent line is FDA 510 K 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 and on a colorimetric version of this reagent 17 times by other authors 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:

Plasma Free Hemoglobin (C462-0A)*:

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 very small amounts of hemoglobin that may be present in a plasma sample. The method can be run on most clinical chemistry analyzers unlike similar methods in the past. The method is sensitive and accurate enough to measure hemoglobin at levels approaching 2 mg/dL (1.2 µmol/L). The method demonstrates linearity on most analyzers to 100 mg/dL (60 µmol/L).

Ethylene Glycol – Quantitative Test (C504-0A)*:

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 poisoning is not determined to have occurred and is not quickly 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 second component in some antifreeze products and also a chemical used as an additive in some human foodstuffs.
NOTE: Neither Diethylene Glycol or the antidote 4-methylpyrazole (fomepizole), the latter tested to a level of 30 g/L, showed any interference in the assay.

Methanol – Quantitative Test (C604-0A)*:

Clinically diagnosing methanol poisoning has been difficult to do as it has required the use of specialized GC equipment not always available in a clinical laboratory. Severe methanol intoxication can be fatal. Catachem’s new methanol test reagent can be used on a regular clinical chemistry analyzer. The method is linear to 100 mg/dL (31 mM/L) and shows no interference from ethanol to a concentration of 690 mg/dL (at 400 mg/dL ethanol a human being is comatose). A 29 sample correlation against a GC-FID method gave a Deming Regression equation of y=0.899x – 2.66, r = 0.982.

Ethylene Glycol – FasTox Test Kit (C504-0C)*:

Designed for the low volume user for use on a simple spectrophotometer (340 nm wavelength), this product provides three semi-quantitative tests each with low and high controls. Each test is designed for one time use directly off the shelf with 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.

Methanol – FasTox Test Kit (C604-0B)*:

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. Product has an 18 month shelf life.

 
 
*For research use only

For more information on our Ethylene Glycol assays, please view our brochure.

For more information on our Plasma Free Hemoglobin assay, please view our brochure.