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Core Test®

Core Test®

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CoreTest®

One Drop of Blood for Detection of Acute Kidney Injury Biomarkers, an easy-to-use CoreTest system for medical diagnostics is applied to decreases the risk of mortality and lifelong dialysis.

Why AKI is Important?

AKI is a common clinical syndrome, and occurs in approximately 10−15% of the patients admitted to the hospital, while its incidence in intensive care has been reported in more than 50% of patients. Its typical clinical manifestation is a sudden decrease in glomerular filtration rate (GFR), following a rapid increase in serum creatinine levels and/or decrease in urine output, leading to electrolyte disturbance, metabolic acidosis, and volume overload. More seriously, it may be accompanied by dysfunction or failure of other organs.

NGAL: An ideal biomarker

An ideal biomarker is non-invasive, easily measured, and affordable, yielding rapid results. It originates from accessible sources like blood or urine. It demonstrates high sensitivity and specificity, facilitating early disease detection, treatment monitoring, and prognostic prediction. Additionally, it allows risk stratification and provides valuable insights into disease mechanisms.

NGAL

NGAL(neutrophil gelatinase-associated lipocalin), in the case of acute kidney injury (AKI), NGAL is secreted in high levels into the blood and urine within 2 hours of injury. Because NGAL is protease resistant and small, the protein is easily excreted and detected in the urine. NGAL levels in patients with AKI have been associated with the severity of their prognosis and can be used as a biomarker for AKI.

Acute Kidney Injury Definition

Increase in SCr by

0.3mg/dL

within 48 hours

Increase in SCr to

1.5times

baseline

Urine volume <0.5 mL/kg/h for

6

hours

References: 2012 AKI GUIDELINE, Kidney Disease Improving Global Outcomes(KDIGO)

Identification of AKI Risk

Traditional Test

In clinical practice, AKI warning systems can automatically report an acute rise in serum creatinine (SCr), as defined in agreed guidelines, and when linked to KDIGO-recommended care bundles, may contribute to improved patient outcomes. However, such increases in SCr may be delayed by 48–72 hours in an AKI setting. Under these conditions, therapeutic care bundles may be initiated after glomerular function has already declined and potential irreversible organ damage may already be present.

CoreTest® Test

With only one drop of blood sample added to the chip, NGAL level can be obtained within 10 minutes. Several molecules have been identified as potential markers for early detection of kidney damage before serum creatinine rises. Of the early kidney tubular damage or stress biomarkers, robust data are available on the diagnostic and prognostic accuracy of urinary neutrophil gelatinase-associated lipocalin (NGAL). NGAL concentrations peak approximately six hours after tubular injury and follow a dose-response curve with respect to injury severity.

CoreTest Safeguards Your Health

The clinician can obtain results in less than 10 minutes with one drop of blood by using the AKI chip and the portable CoreTest system. By identifying patients at risk of AKI early, clinicians can take more appropriate action to manage fluid levels, avoid nephrotoxic agents, and potentially prevent permanent kidney damage.

Touch screen High system reliability Easy to insert cassette Easy-to-use interface Small volume Made from durable materials Can be test in clinic room 2 USB ports & quick data transfer

Artificial Antibody

Vacuum module

Blood Filter

Easy to operate

Put into the chip

Drop sample

Test results

Remove the chip and ready for next test

Specifications

● Operating Temperature 16 - 30 ℃
● Measuring Range 10 - 3000 ng/mL
● Sample Volume 12 μL
● Operating Time 10 min
● Interface USB port X2
● Electrical Requirements VAC 110V / 60Hz
● Classification Class 2
● Analyzer Dimensions 230 x 125 x 192 mm
● Weight 3.5 Kg
● Catalog Number 200-10-001
● Store at 16 - 30 ℃
● Sample Type Whole Blood
● Measuring Range 10 - 3000 ng/mL
● Sample Volume 12 μL
● Shelf-life 12 months
● Dimensions 55.0 x 33.0 x 10.1 mm
● Package 1 test/cartridge