Diagnostic accuracy of a reagent strip for assessing urinary albumin excretion in the general population.

Maria Stella Graziani, Giovanni Gambaro, Lucilla Mantovani, Alessandro Sorio, Tewoldemedhn Yabarek, Cataldo Abaterusso, Antonio Lupo, Paolo Rizzotti

Research output: Contribution to journalArticlepeer-review

33 Citations (Scopus)


BACKGROUND: Albuminuria is a sensitive marker of renal derangement and has been included in a number of studies investigating chronic kidney diseases (CKDs). This study is aimed to evaluate the diagnostic performances of a strip for measuring the albumin/creatinine ratio (ACR) in the general population and to compare it with those found in a diabetic population. METHODS: Urine samples were obtained from 201 consecutive subjects enrolled in an epidemiological study and from 259 type 2 diabetic patients. Urine was tested for albumin and creatinine using the strip (Clinitek Microalbumin) and laboratory methods. A hundred samples were stored under various conditions to assess analyte stability. RESULTS: In the general population, the strip test reached a 90% sensitivity and 91% specificity, considering the laboratory method as the 'gold standard', sparing >80% of subjects the laboratory tests at the expense of a 1% false negative rate and an 8% false positive rate. Regarding sensitivity and specificity, the ACR test performs very similarly in the general population and in the diabetics. The stability study showed that storage at -20 degrees C induced a significant decrease in the albumin concentration with both methods, such that 5% of the samples were re-classified in the lower ACR class. Storage at -80 degrees C for up to 12 months did not affect the measurement with both methods. CONCLUSION: Clinitek Microalbumin strips can be used for screening purposes in the general population since they correctly classify a significant percentage of subjects, particularly those with a normal albuminuria. Storage at -80 degrees C does not affect strip results. Screening with the strip and confirming positive results with a wet chemistry method are an efficient strategy for detecting albuminuria in the general population.
Original languageEnglish
Pages (from-to)1490-1494
Number of pages5
JournalNephrology Dialysis Transplantation
Publication statusPublished - 2009


  • CKD
  • microalbuminuria


Dive into the research topics of 'Diagnostic accuracy of a reagent strip for assessing urinary albumin excretion in the general population.'. Together they form a unique fingerprint.

Cite this