BiliDx Bilirubinometer
NHHDEVBDX
- Quantifies bilirubin (TSB) concentration in a few drops of blood applied to a lateral flow card (sold separately)
- Can accurately measure bilirubin in samples with high HCT and with high direct bilirubin (DB) levels
- Portable rechargeable reflectance reader (powered by a lithium battery charged through a Mini B -USB port ( DC 5V – 0.5A – 2.5 W )
- Allows bilirubin estimation at the point of care without a laboratory
- More accurate than transcutaneous bilirubinometer method
- Does not require advanced training
- Results in 5-10 minutes
- No reagents
BiliDx Bilirubinometer
Jaundice is a significant cause of infant morbidity, particularly in South Asia and Latin America. Many infants are born with too much bilirubin circulating in their blood. Left untreated and at high levels jaundice can have significant long-term effects including hearing loss, cerebral palsy and even brain damage. In many hospitals and clinics, the only way to get a clear assessment of bilirubin levels is by sending a sample to a laboratory and using a centrifuge. Laboratory assessments were found to take on average 20 hours (in a study in Uganda). Yet, infants with high bilirubin would benefit from immediate diagnosis as well as ongoing point of care monitoring of status during and after treatment (e.g. phototherapy).
The BiliDx (reader and cassette system) was developed to allow a fast, blood-based determination of bilirubin levels at the point of care. The device uses lateral flow cassettes to determine bilirubin levels in the blood sample, delivering results in minutes and saving the clinician precious hours of time. A blood sample is transferred onto the lateral flow cassette. The lateral flow strip separates the plasma from corpuscular components of the blood and allows the determination of total serum bilirubin (TSB) by reflectance spectroscopy using the reader.
The TSB determination by the BiliDx does not require the use of reagents, simplifying the process of measurement and making it point of care. Once loaded on the strip, the bilirubin concentration result is obtained within just a few minutes. The BiliDx allows the determination of bilirubin concentrations between 1 mg/dL and 40 mg/dL (17 and 684 mol/L) delivering accuracy that is comparable to traditional clinical laboratory methods.
The BiliDx can take 600 measurements on a single charge.
Product and ordering information
- Minimum quantity of three readers and three sets of 50 tests
- English instructions available
- Not for sale within the United States (not FDA approved)
Regulatory approval information
- Meets WHO guidelines for use in low-resource settings
- The BiliDx is made by Hadleigh Health Technologies which is an ISO 13485 registered company
- The BiliDx is seeking FDA approval in 2024 but does not yet have it
https://www.thelancet.com/journals/langlo/article/PIIS2214-109X(21)00131-5/fulltext
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10409260/
Specifications
Lateral flow test strips sold separately
Linear Range: 0.4 to 30mg/dL
Response Time: < 10 Seconds
Accuracy: +/- 20% from 5 to 30 mg/dL
Resolution: 0.1 mg/dL
Sample Size Required: 75μl (Whole Capillary Blood)
Reagent Composition: Does Not Contain Any Reagent
Strip Shelf Life: 4 Years
Voltage Input: AC 100-240V (50/60Hz) Output: DC5V/2.0A
Battery Rechargeable. Runs ~600 tests per charge
Product materials and instruction documents
Maternova Instructions For Use (IFU) are available in English.
Where is the price?
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- Quantifies bilirubin (TSB) concentration in a few drops of blood applied to a lateral flow card (sold separately)
- Can accurately measure bilirubin in samples with high HCT and with high direct bilirubin (DB) levels
- Portable rechargeable reflectance reader (powered by a lithium battery charged through a Mini B -USB port ( DC 5V – 0.5A – 2.5 W )
- Allows bilirubin estimation at the point of care without a laboratory
- More accurate than transcutaneous bilirubinometer method
- Does not require advanced training
- Results in 5-10 minutes
- No reagents
BiliDx Bilirubinometer
Jaundice is a significant cause of infant morbidity, particularly in South Asia and Latin America. Many infants are born with too much bilirubin circulating in their blood. Left untreated and at high levels jaundice can have significant long-term effects including hearing loss, cerebral palsy and even brain damage. In many hospitals and clinics, the only way to get a clear assessment of bilirubin levels is by sending a sample to a laboratory and using a centrifuge. Laboratory assessments were found to take on average 20 hours (in a study in Uganda). Yet, infants with high bilirubin would benefit from immediate diagnosis as well as ongoing point of care monitoring of status during and after treatment (e.g. phototherapy).
The BiliDx (reader and cassette system) was developed to allow a fast, blood-based determination of bilirubin levels at the point of care. The device uses lateral flow cassettes to determine bilirubin levels in the blood sample, delivering results in minutes and saving the clinician precious hours of time. A blood sample is transferred onto the lateral flow cassette. The lateral flow strip separates the plasma from corpuscular components of the blood and allows the determination of total serum bilirubin (TSB) by reflectance spectroscopy using the reader.
The TSB determination by the BiliDx does not require the use of reagents, simplifying the process of measurement and making it point of care. Once loaded on the strip, the bilirubin concentration result is obtained within just a few minutes. The BiliDx allows the determination of bilirubin concentrations between 1 mg/dL and 40 mg/dL (17 and 684 mol/L) delivering accuracy that is comparable to traditional clinical laboratory methods.
The BiliDx can take 600 measurements on a single charge.
Product and ordering information
- Minimum quantity of three readers and three sets of 50 tests
- English instructions available
- Not for sale within the United States (not FDA approved)
Regulatory approval information
- Meets WHO guidelines for use in low-resource settings
- The BiliDx is made by Hadleigh Health Technologies which is an ISO 13485 registered company
- The BiliDx is seeking FDA approval in 2024 but does not yet have it
https://www.thelancet.com/journals/langlo/article/PIIS2214-109X(21)00131-5/fulltext
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10409260/
Specifications
Lateral flow test strips sold separately
Linear Range: 0.4 to 30mg/dL
Response Time: < 10 Seconds
Accuracy: +/- 20% from 5 to 30 mg/dL
Resolution: 0.1 mg/dL
Sample Size Required: 75μl (Whole Capillary Blood)
Reagent Composition: Does Not Contain Any Reagent
Strip Shelf Life: 4 Years
Voltage Input: AC 100-240V (50/60Hz) Output: DC5V/2.0A
Battery Rechargeable. Runs ~600 tests per charge
Product materials and instruction documents
Maternova Instructions For Use (IFU) are available in English.