CLINITEK® Microalbumin 2 Reagent Strips

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CLINITEK® Microalbumin 2 Reagent Strips

CLINITEK Microalbumin 2 Reagent StripsIn-office, clinic or hospital testing for early detection of chronic kidney damage

CLINITEK Microalbumin 2 Strips provide semi-quantitative albumin, creatinine and albumin-to-creatinine ratio results in one minute.¹ The CLINITEK Microalbumin 2 test is useful to test for microalbuminuria in patients with risk factors for kidney damage. These risk factors include hypertension, obesity, heart disease, race, and age (60+ years old).²

NOTE: patients with diagnosed diabetes require a quantitative uACR and eGFR test annually to comply with the HEDIS (KED) quality measure.

The strips are run on the CLINITEK Status family of analyzers.

Albumin, creatinine, and albumin-to-creatinine ratio results to help identify clinically relevant microalbuminuria
Results are corrected for varying urine concentrations when used on the CLINITEK Status family of analyzers, replacing the need for 24-hour urine collection and measurement

Features & Benefits

CLINITEK Microalbumin 2 Reagent Strips make it simple and easy to test patients with diabetes. Because testing for microalbuminuria can detect kidney damage in its early stages, physicians may begin intervention earlier than might otherwise have been possible. CLINITEK Microalbumin 2 Reagent Strips permit detection of elevated albumin sooner, more sensitively and more specifically than products designed for general protein testing.^3,4

The CLINITEK Microalbumin 2 Reagent Strips provide semi-quantitative results with a hard-copy report on the CLINITEK Status family of analyzers, making them ideal for point-of-care testing. Patient samples can be tested immediately during a physician, clinic or hospital visit, rather than sending them out and waiting for results. The strips are also convenient for testing random urine samples, eliminating the need to collect a timed sample.

The CLINITEK Microalbumin 2 Reagent Strips are CLIA-waived for use on the CLINITEK Status Family of Analyzers.

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Assays

The microalbumin 2 test includes:

Albumin
Creatinine
Albumin-to-Creatinine (A:C) ratio results (semi-quantitative)

Technical Specifications

Quick Reference Guide for

Getting Started

Did you know?⁵

Hundreds of millions of people in the U.S. are at risk for chronic kidney disease (CKD)^1-8

CKD can be treated, and the earlier the treatment starts, the better.⁹ Early-stage chronic kidney disease is often asymptomatic, making CKD testing imperative for at-risk patients.*

Race*: 124 million^6-8
Obesity: 121 million⁵
Heart Disease: 121 million³
High Blood Pressure: 116 million⁴
Age (60+): 75 million²
Diabetes**: 37 million²

If you are African-American, Hispanic, Native American, or Asian-American, you are at increased risk for kidney disease.

HEDIS requires quantitative uACR for patients with diagnosed diabetes.

CLINITEK Microalbumin 2 and uACR testing can fill
the care gap to help identify kidney damage!⁵

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Services & Support

Education & Training

Did this information help you?

1) CLINITEK Status, FDA Premarket 510(k) Notification - Summary of Safety and Effectiveness.

2) CLINITEK Microalbumin 2 IFU.

3) Diabetes Care, Volume 35, Supplement 1, January 2012 S11,

4) M.S. Graziani, G. Gambaro, L. Mantovani, “Diagnostic accuracy of a reagent strip for assessing urinary albumin excretion in the general population”, Nephrology Dialysis Transplantation, Volume 24, Issue 5, May 2009, Pages 1490–1494,

5) ACR Family Brochure, POC-22-NAM-4203, HOOD05162003325877, 01.2023.

5.1) . Accessed 12-15-22.

5.2) . Accessed 11-11-25.

5.3) . Accessed 1-4-23.

5.4) . Accessed 12-15-22.

5.5) . Accessed 12-15-22.

5.6) . Accessed 12-15-22.

5.7) . Accessed 12-15-22.

5.8) . Accessed 12-15-22.

5.9) . Accessed 1-4-23.

5.10) Kidney disease: Improving global outcomes (KDIGO) CKD work group. KDIGO 2012 clinical practice guideline for the evaluation and management of chronic kidney disease. Kidney Int Suppl. 2013;3:1-150. Accessed 12-15-22.

5.11) American Diabetes Association. Microvascular complications and foot care: standards of medical care in diabetes—2018. Diabetes Care. 2018;41(Suppl. 1):S105–S118. Accessed 12-15-22.

5.12) Inker LA, Astor BC, Fox CH, et al. KDOQI US commentary on the 2012 KDIGO clinical practice guideline for the evaluation and management of CKD. Am J Kidney Dis. 2014;63:713-35. Accessed 12-15-22.

5.13) Alfego D, Ennis J, Gillespie B, Lewis MJ, Montgomery E, Ferre S, Vassalotti JA, Letovsky S. Chronic kidney disease testing among at-risk adults in the U.S. remains low: real-world evidence from a national laboratory database. Diabetes Care. 2021 Sep 1;44(9):2025-32. Available from: https://doi. org/10.2337/dc21-0723. Accessed 12-15-22.

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