A New Tool to Detect Kidney Disease Outside the Hospital

Specifications     For more information

• Fingerstick Capillary Blood Test
• As Easy to Use as Self-Testing for Blood Glucose
• Allows Screening or Monitoring of Kidney Disease
• Based on Nova’s Proven Hospital Creatinine/eGFR Meter

Nova Max Creatinine/eGFR is an important new tool to improve kidney care through detection of kidney disease early enough to successfully treat the disease. Nova Max is a fast, accurate and easy to use meter and biosensor for kidney function testing. The measurement technique is very easy to use, virtually identical to the use of a glucose meter by people with diabetes. Creatinine and estimated glomerular filtration rate (eGFR) results are reported (with or without race as a factor) using the CKD-EPI equation from a small, capillary fingerstick blood sample in just 30 seconds. Test results can be wirelessly communicated to Bluetooth enabled applications for review and intervention by healthcare professionals.

Accuracy

Nova’s FDA cleared StatSensor Creatinine enzymatic technology has been used in hospital point-of-care meters for over 15 years. In a 2021 university medical center study of 670 patients sponsored by the International Society of Nephrology, Nova’s sensor technology proved more accurate than the laboratory Jaffe Creatinine/eGFR method when both methods were compared to the gold standard measured GFR (mGFR)

Very Good Correlation to Hospital Lab Analyzer

In a study performed for regulatory submission, 517 patients at three different sites had Nova Max Creatinine eGFR tests performed on fingerstick capillary blood samples. At the same time a venous blood sample was drawn and a laboratory analysis of creatinine/eGFR was performed. The creatinine method correlation was:

Very Good Sensitivity and Specificity

Sensitivity is the ability of a method to detect patients with the disease and specificity is the ability to detect patients without the disease.

Patients with an eGFR>60 ml/min/1.73m2 are considered to have normal kidney function, patients with eGFR<60 ml/min/1.73m2 are considered to have kidney disease. Nova Max uses the CKD-EPI equation to calculate eGFR. The results from this 517-patient study were:

Very Good Method Precision

Creatinine within-run and day-to-day precision studies were performed at three creatinine levels. 120 replicates of whole blood were used to calculate within-run precision and 240 replicates of controls were used to calculate day-to-day precision. The creatinine SD and CV%
are shown below:

Simple Test Procedure

As Easy as Glucose Self-Testing Performed by People with Diabetes

Capillary Blood Testing Eliminates a Venous Blood Draw
Capillary blood testing eliminates the need for a venipuncture by a phlebotomist, blood drawing tubes and needles. 

Small Blood Sample
Nova Max Creatinine/eGFR capillary blood testing requires a 1.2 microliter finger prick sample and is virtually painless for the patient.

Other Features

CKD-EPI 2021 eGFR Equation Is Used
This is the preferred method for estimation of glomerular filtration rate because of better accuracy at detecting early stages of kidney disease. The equation is offered with or without race as a factor.

Wireless Bluetooth Communication
Nova Max Creatinine/eGFR connects patient kidney data from the meter with healthcare professionals, medical records, or other applications

Bright, Color Touchscreen
The color touchscreen simplifies entry of patient age and sex. Abnormal test results are flagged with symbols and color.

Data Storage
Nova Max Pro stores up to 400 patient and quality control results. Results are easily recalled for review or data transmission.

Current Field Studies

Nova Max Pro Creatinine measuring technology is based on the Nova StatSensor Creatinine technology which has been used in point-of-care applications for over 15 years. Nova’s technology has been proven in numerous non-hospital settings, including pharmacies, community health centers, imaging centers, clinics, physician offices, and home testing.

Pharmacies

A recent study highlight-ed the value of eGFR testing in community pharmacies in Spain.⁶ The Nova creatinine eGFR meter was used to evaluate patients that were asymptomatic for CKD but were either on potentially nephrotoxic medications or at risk for chronic kidney disease. Almost 200 patients were tested in four pharmacies, with 44% of them showing an eGFR of <60 (the level indicating kidney disease). Of these patients with a low eGFR, almost half of them (43%) had medication dosages that required adjustment or discontinuation. This study highlights the value of eGFR testing in the outpatient setting, and the important patient improvements it can bring. The study is being expanded to 5,000 patients. Another pharmacy study in the Netherlands used Nova Creatinine/eGFR to screen asymptomatic CKD patients with previously unknown kidney disease who were prescribed non-steroidal anti-inflammatory drugs. The authors found that “POC measurement of creatinine with eGFR estimation changed the prescription of NSAIDs in almost 25% of patients with previously unknown renal function.”⁷

Community Screening of At-Risk Individuals

Nova Creatinine/eGFR measuring technology has proven to be an excellent tool for kidney screening and early detection of kidney disease in community health centers. One study concluded: “We effectively utilized a clinical symptom-based score and deployed POC creatinine and urine dipstick tests for screening and identification of patients with kidney dysfunction across three different low-resource settings. We described a practical approach for evaluating and classifying patients as AKD, CKD, or NKD in the absence of knowledge of their prior state of kidney health, to guide further evaluation and follow-up.”³

Nova POC devices have also been used to assess kidney function in community healthcare clinics in Low and Middle- Income Countries (LMIC) to screen for patients at risk for kidney disease.^{4, 5} Even in wealthier countries, individuals living in remote areas face obstacles in terms of access to routine laboratory testing, and Nova Max eGFR can be a cost-effective solution to allow for screening and monitoring of these populations. Importantly, there is no sacrificing quality and accuracy using the Nova device to evaluate kidney disease, as a head-to-head comparison with the Nova eGFR device showed it to be more accurate than a hospital laboratory analyzer when compared to a true measured GFR.⁴

Clinics and Physician Offices

AstraZeneca has begun a study using Nova Max Creatinine/eGFR in hundreds of physician offices in 25 countries to screen asymptomatic but potentially at-risk patients for kidney disease. As with other screening studies, the thesis is that early detection will improve outcomes for patients by allowing early treatment.

Imaging Centers

Administering contrast dyes for radiologic exams is known to be potentially nephrotoxic, making kidney function assessment recommended prior to administering contrast media. Since many of these studies take place in outpatient imaging facilities, patients without recent eGFR test results may face cancellation of their exam or delays. Several studies have now evaluated the use of Nova Biomedical devices for testing in these facilities, with results that show acceptable accuracy and error rates when compared with central laboratory analyzers.^8-14 In the case of procedures on patients at high risk for contrast-induced nephropathy, such as cardiac catheterization and peripheral arteriography, contrast loads can be high, and kidney injury may not be apparent for several days after the procedure. In these cases, patients could be sent home with the device to allow early detection of kidney injury.

Home Testing

There are numerous opportunities for patients to benefit from eGFR self-testing. Monitoring of eGFR at home provides convenience, cost-effectiveness, and improved outcomes by early detection of kidney disease. Populations that have been studied using the Nova meter at home include cardiac catheterization patients (unpublished data from ongoing study), renal transplant patients, and Native American populations living in remote settings.15-19 Ongoing home self-testing studies with the Nova meter are being conducted by the Chronic Renal Insufficiency Cohort (CRIC)* for monitoring patients with kidney disease.²⁰

Home Testing for Kidney Transplant Patients
After kidney transplantation, early detection of transplant failure is mandatory to minimize harm to the patient and permanent damage to the transplanted organ. Patients therefore have laboratory eGFR/creatinine tests on average 20 times during the first year post transplantation. The high frequency of outpatient visits after kidney transplantation is burdensome to the recovering patient and to health care system capacity. A self-monitoring program can improve post transplantation care by early identification of acute rejection due to higher frequency of testing, decrease the high number of outpatient visits, increase patient satisfaction, all of which may improve kidney-graft survival. A study is beginning at the UK National Health Service (NHS) to monitor kidney transplant patients at home by having their self-test results transmitted automatically to clinical staff for evaluation and intervention.

Kidney Disease is a Worldwide Healthcare Crisis

Kidney disease (CKD) is a major healthcare crisis. It is growing at an accelerated rate, rising from 13th to 10th place in the World Health Organization ranking of most common causes of death. It currently represents a huge healthcare economic burden in every country and because of its growth it will be an even larger one in the future unless CKD can be detected and treated early.

If Detected Early, Kidney Disease Progression can be Prevented or Delayed ¹
As many as 90% of people with kidney disease are undiagnosed.¹ In the U.S. alone 15 million adults are estimated to have CKD but 13.5 million are unaware they have it. Kidney disease is often termed the “silent killer” because it shows no symptoms until it is very late stage when there are few treatment options other than dialysis, a very difficult end-stage treatment for patients and very expensive for the healthcare system. Because kidney disease is almost always detected too late, treatment options are still associated with high mortality. Today, the availability of the first drug to retard the progression of kidney disease (Dapagliflozin/Farxiga, Astra Zeneca) makes it even more important to detect kidney disease early so treatment can be started before it is too late.² Other novel therapeutics are in various stages of development and also show potential to treat kidney disease.³

Global Map of Chronic Kidney Disease, Both sexes, all ages, annual % change, 1990 to 2019, deaths per 100,000

Nova Max Pro Specifications