Calmark Neo-Bilirubin Test Cassettes

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Calmark Neo-Bilirubin single-use test cassette for a quantitatively measurement of bilirubin in whole blood of newborns. Designed for use with the Calmark Neo-Bilirubin Point-of-Care Diagnostic System.
● Minimum Order Quantity (MOQ): 20 tests
● Seller Name: Calmark
● Seller Location: Sweden
● Warranty Term: Not applicable
● Regulatory Approvals: CE; ISO 13485:2016

SKU: 0-82444-BR Categories: , , Tag:

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Description

Calmark Neo-Bilirubin test cassette is used together with Calmark POC-Analyzer for a quantitatively measurement of bilirubin in whole blood of newborns, preventing hyperbilirubinemia and jaundice. Test cassettes are delivered in boxes of 20 pieces.

Only a few drops of blood are needed, and the analysis can take place wherever the patient is located, eg. return visit at the birth clinic or at the maternity ward. The result is presented on the POC-analyzer display after only 2 min, which reduces both costs and time.

Read our Buyer's Guides to learn more about Diagnosing and Treating Newborn Jaundice.

Key Features

Usability
Rapid, safe, and easy measurement of bilirubin in blood from newborns. Optimized for accurate analysis with just a few drops of blood. The result is presented after only 2 min, which reduces both costs and time.

Accurate
High-precision testing with a quantification range of 150-500 µmol/L (9-29 mg/dL). High tolerance for hemolysis and accurate results at up to 60% hematocrit, which can be a problem with traditional test methods.

Quality Design
Each test cassette contains information needed for automatic calibration of the results; no recalibration needed

Specifications

Performance Neo-Bilirubin Test

  • Detection range: 150-500 µmol/L (9-29 mg/dL)
  • Accuracy <150 µmol/L (<9 mg/dL): 12.9%
  • Accuracy 150-500 µmol/L (9-29 mg/dL): 8.8%
  • Accuracy >500 µmol/L (>29 mg/dL): 4.0%
  • No interference from hemolysis up to 2 g/L
  • Accurate results at up to 60% hematocrite
  • Measurement time: 2 minutes
  • Shelf Life: 12 months

Standard Accessories

Not applicable

Optional Accessories & Add-ons

Not applicable

Product Documents, Manuals & Brochures

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Brochure

Regulatory Certificates

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ISO 13485

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Free Sales Certificate

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Declaration of Conformity - CE Mark

Videos

FAQ

Where can the tests be performed?

Calmark POC is a point-of-care (POC) system which means that tests can be performed where the baby is. The device can be used at any healthcare unit that needs to check or monitor the bilirubin levels in newborns. The instrument is portable, but should not leave the health care unit, i.e. it is not mobile.

Which unit in a hospital or healthcare facility should use the Calmark POC system?

The end-user can be wherever the baby is during day 2-7 in life, for example: hospital’s delivery and maternity wards, postnatal follow up unit, neonatal care unit, maternity care centres, smaller paediatric or neonatal clinics or offices.

When should the test be performed?

The recommendation for the Neo-Bilirubin test is to measure infants between 2-6 days after birth (full-term pregnancy). At this is the point in time the serum or plasma bilirubin level reaches its peak in most newborns, and the risk of hyperbilirubinemia is greatest. Timely detection, monitoring and treatment started during this time is an effective way to prevent most bilirubin induced morbidity.

Why is it important to use an invasive method for bilirubin diagnostics?

According to the guidelines in most countries, a blood sample should be taken if the bilirubin levels rise above 150 µmol/L (9 mg/dL), 2-3 days after birth. For lower levels of bilirubin, it is enough to use a transcutaneous meter. Approximately 20% of newborns require an additional blood sample to be taken.

What is the advantage of using Calmark POC instead of a traditional laboratory blood test?

The Calmark POC – Neo-Bilirubin system is developed for baby blood and requires only a few drops of whole blood to measure bilirubin levels quickly and with high precision. Laboratory testing requires a larger volume of scarce baby blood that breaks easily (hemolysis) and incurs often higher total costs due to manual handling of baby blood by the laboratory personnel.

Can I use the same test cassette for more than one test?

No, the test cassette can be used only once.

How much blood should I apply into the test cassette?

Make sure to apply enough volume of blood into the intended cavity of the test cassette. Fill the cavity completely (at least 70 μL, approximately 2-3 drops).

How should I take the venous blood samples?

The blood sample can be taken in different ways, use your normal routine. For example take the blood sample with a needle, with a syringe and needle, or with a butterfly. In some countries it is common to use butterfly needles for single use blood samples. Either drop directly from the butterfly tube onto the test cassette or collect from the butterfly tube into a capillary tube and from there drop into the test cassette.

What happens if I apply too little or too much blood into the cassette?

The test cassette can handle too much blood and will discard the volume that is not needed. If the sample volume is too small the instrument shows error code T1. Open the lid, remove the test cassette, and discard it. Redo the test with a new cassette. You might need to clean the cassette holder and the camera window properly before you redo the test.

What type of blood should I use?

Venous whole blood should be used in order to have the most accurate results. Calmark POC is validated on venous whole blood and as long as this is used, we can ensure precise data within the specification range. The system can technically handle capillary blood (punctured in the baby´s heel or fingertip for example), but we cannot guarantee accurate results due to large risk of preanalytical faults like squeezing the tissue during sampling.

Is it possible to use anticoagulation coated disposables?

Yes, EDTA tubes, and sodium or lithium heparin tubes.

Studies & Trials

Not available at this time

 

Package Contents

  • 20x Neo-Billirubin Test Cassettes (in box)

Warranty

Not applicable

Testimonials

Not available at this time

 

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