About Aviv Biomedical & AVIV-BHS

Aviv Biomedical (“Aviv”) is a leading edge medical instrumentation developer. It was founded in 1971 by the late Jack Aviv in Lakewood, NJ, USA, initially to service spectrophotometers, circular dichroism spectrometers and spectrofluorometers. The company is a family-owned enterprise run today by the Aviv family.

 

In 1975, under license from Bell Telephone Research, the company introduced a front surface fluorescence instrument to detect iron deficiency and lead poisoning in whole blood, known as a Zinc Protoporphyrin (ZPP) Hematofluorometer. Over 2,700 instruments have been distributed worldwide, and the product is approved by the US FDA. Aviv is a global leader in development of hematofluorometers and owns proprietary knowledge and IP regarding optimal analytical performance. The AVIV-BHS is the latest instrument in the Company’s portfolio.

 

Since 1971, Aviv Biomedical has strived to provide the best scientific instruments and support possible. The product line includes a ZPP hematofluorometer for whole blood screening for iron deficiency and lead poisoning. Aviv strives to produce an unparalleled medical instrument capability and provide superior service.

 

Aviv has developed the BHS instrument for assessment of neonatal jaundice. This is the such  first Bilirubin Hematofluorometer System on the market and the first instrument capable of measuring Bilirubin Binding Capacity.

Clinical


About Neonatal Jaundice



Neonatal jaundice, caused by high levels of bilirubin, is a common disorder in ~60% of newborns with ~18% of these at risk for neurological disorders or death.  All modern hospitals monitor neonatal bilirubin levels (Total Serum Bilirubin or TSB), however, predicting risk solely on TSB levels is known to be inadequate.

 

Neonatal jaundice is the most common condition in newborns that requires medical attention and hospital readmission. The yellow coloration of the skin and sclera in newborns with jaundice is the result of accumulation of unconjugated bilirubin. In most infants, unconjugated hyperbilirubinemia reflects a normal developmental phenomenon. However, in some infants, serum bilirubin levels may rise excessively.  This can be a major cause for concern because unconjugated bilirubin is neurotoxic, and can cause death in newborns, and lifelong neurologic sequelae in infants who survive (kernicterus). For these reasons, the presence of neonatal jaundice frequently results in diagnostic evaluation. It is particularly prevalent in premature babies. Jaundice can be treated with phototherapy or blood transfusions.

Jaundiced Baby
image of a jaundiced baby for Aviv Biomedical

Normal Baby
image of a normal baby for Aviv Biomedical

image of clinical work for Aviv Biomedical

The Clinical Problem



The clinical problem addressed by Aviv with the AVIV-BHS instrument is that the traditional reliance on Total Serum Bilirubin (TSB) requires many mitigating factors to be taken into account, and still is not a complete assessment of risk.

 

Free bilirubin causes neurological injury in neonates. Not only are TSB levels important, but also the neonate’s ability to bind bilirubin. This property is called Bilirubin Binding Capacity (BBC).

 

This capacity varies significantly in a child's early days, but is not adequately accounted for. Low BBC at any level of TSB indicates higher risk. The solution has been a heavy reliance on treatment (usually phototherapy or blood transfusion), probably to the extreme, resulting in increased costs and delayed releases of newborns.  Given the current state of art, the alternative would be premature release of sick babies, with sometimes dire consequences. 

 

Measuring both TSB and BBC improves the accuracy of identifying the risk, but this has not been possible up to now.  Pre-term infants are particularly challenging, as they defy the guidelines for full-term infants.  For these cases, guidelines reduce the thresholds of tolerable TSB.  The degree of adjustments is less certain, and physicians are left to their own devices to optimize health care for these babies.  There is an increasing realization that the risk factors increase significantly when the levels of bilirubin begin to approach the blood’s carrying capacity. 

 

Infants are released from the hospital as soon as one day after birth, before a potentially damaging spike of bilirubin occurs, so assessment of BBC can play a major preventative role. Rapid tests using the AVIV-BHS for BBC could prevent re-admission in ~10% of affected babies.


Clinical Trials of AVIV-BHS



BBC has been shown in a comprehensive retrospective analysis to provide improved, clinically relevant and actionable information. The BBC test using the AVIV-BHS is in clinical trials at a leading children’s hospitals.  This collaboration is a clinical study of 200 neonates. See more information here. Guidance for use of bilirubin binding capacity measurements has been suggested in a leading publication.

image of clinical trials for Aviv Biomedical

Technology

The Aviv Bilirubin Hematofluorometer System (AVIV-BHS), is designed for assessment of jaundice in newborn babies.

 

Principle of Operation


Fluorescence is the ability for light that has been absorbed to be re- emitted at a longer wavelength. The hematofluorometer assays take advantage of the naturally occurring fluorescence of bilirubin when it is bound to serum albumin.  Bilirubin that is free or bound elsewhere in the blood does not fluoresce at significant levels.  When blue light is absorbed by the bilirubin the albumin bound bilirubin emits green fluorescent light. 

 

The binding assay is based on fluorescent measurements of two 20 μl drops of blood. The fluorescence of the first drop, with no additional treatment or reagents, is measured to determine the Bound Bilirubin concentration. The second drop has excess bilirubin added to saturate all of the available binding sites.  Measurement of the second drop gives the Binding Capacity.  The difference between the two measurements is the Reserve Binding Capacity. Obviously, a strong Reserve Binding Capacity shows little risk, while a weak or non-existent Reserve Binding Capacity shows risk for injury. This is a functional assay that directly measures the binding capacity, so issues such as high TSB, or weak binding ability, are automatically accounted for.

 

The Hematofluorometer is designed for fluorescent detection in whole blood. Blood has extreme optical properties, so conventional fluorescence measurements are not possible. The device accounts for the absorbance and scattering properties of whole blood.  Extractions or separations are not necessary.  Optical measurements are made in seconds.  

Product

The AVIV-BHS allows, for the first time, rapid measurement in neonates of Bilirubin Binding Capacity (BBC), a critical factor in preventing or allowing the development of neonatal jaundice which inflicts underlying neurotoxicity.

 

The AVIV-BHS provides a functional assay of BBC on as little as 50 µl of blood. The system is comprised of (1) a dedicated instrument, computer, sample carrier, bar code reader and (2) a reagent kit of consumables with calibrators and controls.

The system exploits the native fluorescence of bound bilirubin.  Conventional fluorometers are poorly suited for blood measurements, as a right-angle optical path cannot work due to extreme absorption and scattering of light by blood. The AVIV-BHS uses only one surface. Light enters and exits the same surface. It produces results in under 5 minutes, including BBC and Saturation Index (a proxy for free bilirubin).

 

Aviv has received several SBIR grants from the US National Institutes for Health for development of the AVIV-BHS. Aviv has filed a US patent application for the AVIV-BHS.



Contact Us

For more information about Aviv Biomedical and partnering opportunities for the AVIV-BHS, please contact us using the below details or by filling out the form.

For general and partnering information

Dr. Bill Mason
The Sage Group
The Old Black Barns
Lord’s Lane, Ousden CB8 8TX
UK
 +44 7785 950134
 avivbhs@sagehealthcare.com


US Enquiries

Wayne Pambianchi
The Sage Group Inc.
1802 Route 31 North
#381 Clinton
New Jersey 08809
USA
 +1 908 2306170
 corporate@sagehealthcare.com