Novel Assay Methods for Methanol Toxicity

Period of Performance: 09/25/2000 - 03/24/2001


Phase 1 SBIR

Recipient Firm

Micronix, Inc.
Carmel, IN 46032
Principal Investigator


Poisoning from methanol is a potentially life threatening medical emergency that can cause multi-organ failure and permanent visual impairment. For the next century, methanol has been proposed as an alternative, environmentally cleaner automotive fuel. Since other industrial uses of methanol are also expected to expand, the incidence of poisonings is likely to increase. Methanol is metabolized in vivo to formic acid (formate), the major toxic metabolite. The only affirmative diagnostic tool is determination of blood levels of methanol or formate. Unfortunately, access to testing for methanol is restricted, and for formate essentially non-existent. This leaves practitioners with relatively unspecific physical signs and surrogate laboratory tests to make the diagnosis. As numerous other conditions can lead to anion/osmolol gap acidosis, diagnosis can be enshrouded in mystery. The applicant proposes to develop specific enzymic methods for blood methanol and formate for use on existing clinical analyzers and at the patient point-of-care (POC). The POC method is a dual-analyte test tab device for the simultaneous estimation of methanol and formate from approximately two microliters of whole blood without centrifugation or any other form of sample or reagent handling. PROPOSED COMMERCIAL APPLICATION: Poisoning from methanol can lead to permanent visual impairment and death. Acidosis from formic acid needs to be differentiated from other forms of metabolic acidosis. Assay of methanol is currently done by semi-quantitative gas chromatographic (GC) "volatile screens", following by confirmatory analysis by GC or GC/MS. These methods are not available in most labs. Testing for formate is esentially non-existent. No clinical analyzer currently offers either a methanol or formate method. The proposed products would solve these problems.