Author(s)

Lei Zhang ¹, Feng Yang ², Junzhe Zhu ³

Affiliation(s)

¹ Zhejiang Gongshang University, Hangzhou, Zhejiang, 310018, China
² Community Health Service Center, Hangzhou, Zhejiang, 310000, China
³ Wenzhou Medical University, Wenzhou, Zhejiang, 310000, China

Corresponding Author

Lei Zhang

ABSTRACT

The Urinary Tract Infections (UTI) Test, an in vitro diagnostic tool, is designed for the qualitative detection of Leukocytes, Blood, Nitrite and Protein in human urine, with potential for self-testing. This study comprehensively evaluates its performance, including positive coincidence rate, negative coincidence rate, total coincidence rate and consistency with a commercially available urinalysis reagent strip. A total of 206 clinical urine specimens were tested using the UTI Test (Hangzhou Alltest Biotech Co., Ltd) and the ACON urinalysis reagent strip as a reference. The results showed a high positive coincidence rate of 98.36%, a negative coincidence rate of 100%, a total coincidence rate of 99.51% and a Kappa value of 0.988, indicating excellent consistency. Additionally, the test demonstrated good usability, suitable for self-testing scenarios, with most users finding the instructions, procedure and result interpretation easy to understand. These findings suggest that the UTI Test is a reliable and practical in vitro diagnostic tool, with potential for self-testing, for the qualitative detection of relevant markers in urine, contributing to the timely diagnosis of UTIs.

KEYWORDS

Urinary Tract Infections Test; Leukocytes; Blood; Nitrite; Protein; Urinalysis; Self-Testing; in Vitro Diagnosis

CITE THIS PAPER

Lei Zhang, Feng Yang, Junzhe Zhu, Evaluation of a Urinary Tract Infections Test for Qualitative Detection of Leukocytes, Blood, Nitrite, and Protein in Human Urine. MEDS Clinical Medicine (2025) Vol. 6: 84-88. DOI: http://dx.doi.org/10.23977/medsc.2025.060313.

REFERENCES

[1] Foxman B. Epidemiology of urinary tract infections: incidence, morbidity, and economic costs. American Journal of Medicine, 2002, 113 (Suppl 1A): 5S-13S.
[2] Nicolle LE. Urinary tract infection in older women. Infectious Disease Clinics of North America, 2008, 22(2): 223-237.
[3] Stamm WE, Hooton TM. Management of urinary tract infections in adults. New England Journal of Medicine, 1993, 329(13): 914-920.
[4] Kunin CM. Detection of bacteriuria and pyuria. In: Kunin CM, ed. Detection, prevention and management of urinary tract infections. 5th ed. Philadelphia: Lea & Febiger, 1997: 103-135.
[5] Warren JW, Abrutyn E, Hebel JR, et al. Guidelines for antimicrobial treatment of uncomplicated acute bacterial cystitis and acute pyelonephritis in women. Infectious Diseases Society of America. Clin Infect Dis, 1999, 29(4): 745-758.
[6] Brumfitt W, Hamilton-Miller JM. Urinary tract infections: diagnosis and management. BMJ, 1989, 298(6671): 390-393.
[7] NCCLS. Urinalysis and collection, transportation, and preservation of urine specimens; approved guideline. Wayne, PA: National Committee for Clinical Laboratory Standards, 2001.
[8] Simerville JA, Maxted WC, Pahira JJ. Urinalysis: a comprehensive review. Am Fam Physician, 2005, 71(6): 1153-1162.
[9] Gray VM, Stickler DJ. Urinary tract infection: pathogenesis, diagnosis and management. J Infect Chemother, 2000, 6(2): 63-77.

Sponsors, Associates, and Links

---

• Journal of Neurobiology and Genetics
  
  
• Medical Imaging and Nuclear Medicine
  
  
• Bacterial Genetics and Ecology
  
  
• Transactions on Cancer
  
  
• Journal of Biophysics and Ecology
  
  
• Journal of Animal Science and Veterinary
  
  
• Academic Journal of Biochemistry and Molecular Biology
  
  
• Transactions on Cell and Developmental Biology
  
  
• Rehabilitation Engineering & Assistive Technology
  
  
• Orthopaedics and Sports Medicine
  
  
• Hematology and Stem Cell
  
  
• Journal of Intelligent Informatics and Biomedical Engineering
  
  
• MEDS Basic Medicine
  
  
• MEDS Stomatology
  
  
• MEDS Public Health and Preventive Medicine
  
  
• MEDS Chinese Medicine
  
  
• Journal of Enzyme Engineering
  
  
• Advances in Industrial Pharmacy and Pharmaceutical Sciences
  
  
• Bacteriology and Microbiology
  
  
• Advances in Physiology and Pathophysiology
  
  
• Journal of Vision and Ophthalmology
  
  
• Frontiers of Obstetrics and Gynecology
  
  
• Digestive Disease and Diabetes
  
  
• Advances in Immunology and Vaccines
  
  
• Nanomedicine and Drug Delivery
  
  
• Cardiology and Vascular System
  
  
• Pediatrics and Child Health
  
  
• Journal of Reproductive Medicine and Contraception
  
  
• Journal of Respiratory and Lung Disease
  
  
• Journal of Bioinformatics and Biomedicine