In 2014, the global POCT market for Blood Gases & Electrolytes was estimated to be $1.5 Billion. Laboratory and cart-carried Blood Gases & Electrolytes analyzers have evolved over the years to provide CO-oximetry and Bilirubin, but hand-held analyzers have not evolved like the larger analyzers. HemoPalm is positioned to be the only hand-held analyzer that will provide Blood Gases, Electrolytes, CO-oximetry and Bilirubin in a single disposable cartridge.
The HemoPalm is a blood analysis system consisting of a handheld analyzer and a suite of disposable single use cartridges. HemoPalm integrates full CO-oximetry, measured through spectroscopy (the only method for CO-oximetry) which allows the user to measure total hemoglobin (Hb), Oxy-Hb, Deoxy-Hb, Met-Hb and carboxy-Hb, simultaneously with blood gases and electrolytes measured with electrochemical sensors. CO-oximetry has traditionally been performed using bench-top analyzers that are large, expensive, and usually located in central laboratories. There are many benefits to providing these blood tests near or at the point of care of patients, but these benefits are not realized due to the size and cost of the bench-top analyzers.
In addition, the blood sample collected directly into the cartridge from a finger prick or, in the case of neonatals, a heel prick-prick, as an alternative to an arterial sample taken with a syringe, which makes the technology applicable in the markets outside of a clinical setting. Moreover the pin-prick sample has the potential to change medical practice by replacing the arterial syringe sample. This sample method opens the field of use greatly to include first responders, military, emerging economies and disaster relief. These are all areas where central labs are simply not available. In the hospital setting it allows rapid patient analysis in situations like emergency department triage. Other important applications are long term care facilities, nursing homes and home respiratory therapy. In all cases the HemoPalm allows detailed analysis to be collected by regular caregivers and forwarded to physicians without the need for hospital visits by patients.
The basic HemoPalm cartridge measures three major categories of blood chemistry. The first is a complete analysis of the various hemoglobin (Hb) species in the bloodstream known as CO-oximetry. This analysis includes:
Total Hb – the total amount of hemoglobin present
Oxy-Hb – hemoglobin which has been oxygenated after passing through the lungs
Deoxy-Hb – hemoglobin which has transferred its oxygen to cells
Carboxy-Hb – hemoglobin which is carrying carbon monoxide as for example in the case of a victim of smoke inhalation
Met-Hb – hemoglobin in which the iron is oxidized, whereby the Hb cannot carry oxygen. Nitric oxide used to treat respiratory distress in neonates is an example of a chemical that causes the Met-Hb to increase.
The second category is known as blood gases and includes measurements of:
pO2 –dissolved oxygen in the blood
pCO2 –dissolved carbon dioxide in the blood
pH – the acid/base present in the blood
The third category is the measurement of the electrolytes sodium, potassium and chloride. Electrolytes play a vital role in maintaining homeostasis within the body. They help to regulate myocardial and neurological function, fluid balance, oxygen delivery, acid-base balance and many other functions. From the blood gases and electrolytes, the bicarbonate and anion gap (a measurement of acid not accounted for, e.g. keto-acidosis in diabetics) can be calculated.
The combination of these three groups of measurements provides the clinician with a complete picture of the patient’s blood oxygenation and acid-base balance. The ChroMedX system is comparable with the larger lab analyzers that combine spectroscopy and biosensor technologies. On the other hand, the existing handheld analyzers in the market do not offer this combination of full CO-oximetry measurement using spectroscopy and biosensors. Further, existing handheld devices use conductivity rather than spectroscopy to measure hematocrit, from which the Hb is calculated thereby compromising the accuracy of the Hb results, and cannot measure Oxy-Hb, Deoxy-Hb, Met-Hb and Carboxy-Hb. The hematocrit measurements are reliable in most clinical settings where there are no large variations in protein concentrations, abnormally increased lipids (fats), and abnormal blood cells, which is the case of most seriously ill patients. The second important distinction is that the HemoPalm actually measures hemoglobin oxygen saturation (sO2) by CO-oximetry; the competitors calculate sO2 from the pO2, thereby providing a very misleading assessment of blood oxygenation in for example, a victim of smoke inhalation or carbon monoxide poisoning (Carboxy-Hb will be elevated). Another example is a baby treated with nitric oxide for respiratory distress, who will exhibit elevation of Met-Hb.
A second cartridge, the HemoPalm B, is being developed to measure bilirubin (which may be used to monitor liver function). Bilirubin in high levels is an indication of jaundice, a potentially dangerous condition for newborns of which approximately 15% will develop this condition. The heel-prick method of sampling, as provided by the HemoPalm system, makes sample collection easy with minimal trauma to the baby and minimal blood loss. Once diagnosed, treatment is relatively straightforward, and pre-discharge testing could predict virtually all cases of jaundice and ensure proper parental response and care.
Other cartridges planned for development include testing for lactate, which is an indication of sepsis (blood poisoning), a common and deadly condition in the Emergency Department; creatinine, a measure of kidney function ; and beta-hydroxybutyrate, elevated in diabetic keto-acidosis.