About the product: The urine protein test strips by Diagnox® check the presence and approximate concentration of protein in the urine. Protein is not normally present in the urine at detectable levels. While several non-alarming issues, such as exercise or infection, can temporarily spike protein levels in urine, scientific studies indicate that chronically elevated protein in urine could be due to serious health conditions, including kidney disorders, heart diseases, and various infections. Also, protein in urine during pregnancy may indicate preeclampsia that requires medical attention. Urine protein testing is a vital part of a routine urinalysis by healthcare providers to diagnose diseases, monitor the health of organs, and track treatment regimens.

Diagnox Urine protein test strips are designed to make regular and repeated testing both convenient and affordable, allowing you to take preemptive actions to protect your health and seek timely medical help if your urine protein levels are unusually high.

Individual packing of each test strip helps to keep each strip fresh and immune from humidity and moisture, ensuring a reliable test for every use. Individually packaged dipsticks also offer an extended shelf life, convenient handling, and easy storage.

Intended Use: Diagnox urine protein test strips are intended for qualitative (presence or absence) and semiquantitative measurement (estimate of the quantity) of protein excreted in the urine.

Storage and Handling:
STORAGE & HANDLING

Discard any expired or discolored strips that may have deteriorated.

Store in a dry place at 2–30°C (36–86°F)

Do not freeze. Keep out of direct sunlight.

The strip should remain in the sealed pouch until use.

Do not use if the pouch is torn.

Do not touch the test pad of the strip.

A urinalysis is a test of urine. Urine is produced by the kidneys. Kidneys filter wastes out of the blood, help regulate the amount of water in the body and conserve a balance of nutrients, including proteins, electrolytes, and other compounds that the body can reuse. Therefore, by examining the composition of urine, we can learn a lot about our bodies.

Excess amounts of protein in the body can be tested through urinalysis using a dipstick test. When immersed in a urine sample, the reagent pad on the dipstick changes color as it reacts with urine. With six different levels, the Diagnox urine protein test can detect the presence and concentration of protein in urine from trace to large amounts. This is one of the quickest, most affordable, and simpler ways to test. It is the same kind of test medical professionals frequently use in their practice.

1. Proteins are large molecules that our bodies require to function properly. Protein can be found in all body parts. The kidneys filter extra water and wastes from the blood to produce urine. The tiny filters in the kidneys prevent large protein molecules from exiting the body via urine. In ideal circumstances and with healthy kidneys, the protein should be utilized by the body, e.g., to build and maintain muscles and fight infections. However, protein may leak into the urine if these filters are not working properly. When urine protein is elevated, it is referred to as proteinuria, which may indicate renal or tubular disorders.
   
2. CAUSES OF PROTEIN IN URINE?
3. Relatively benign or temporary medical conditions that can cause elevated protein levels in the urine include dehydration, inflammation, low blood pressure, intense exercise stress, aspirin therapy, and exposure to cold temperatures.
4. 
   More serious medical conditions can also cause proteinuria, such as:
5. Certain immune disorders, including lupus and Goodpasture’s syndrome
6. Acute kidney inflammation (glomerulonephritis)
7. Plasma cell cancer (multiple myeloma)
8. Cardiovascular disease or cardiac infection such as endocarditis
9. The destruction of red blood cells (intravascular hemolysis)
10. Preeclampsia (proteinuria combined with hypertension in pregnancy)
11. Poisoning
12. Trauma
13. Kidney cancer
14. Congestive heart failure
15. Protein buildup in organs (amyloidosis)
16. Kidney stones
17. Diabetes
18. High blood pressure (hypertension)
    
19. The above causes can cause damage to the kidneys. Kidney disease often has no early symptoms. One of its first signs is proteinuria, which is generally detected by a urine dipstick test. Your healthcare provider may order other tests to evaluate how well your kidneys are functioning.

1. Diagnox urine protein test offers clinical-grade accuracy. The analytical performance of the protein reagent pad with urine controls in a multi-site study demonstrates a mean test accuracy of 96.67% (percentage exact match) when reading strips visually (n=180).
   
   Limitations & Interactions:
   Urine tests can sometimes give false results for different reasons, as explained below.
2. 
   Possible causes of false positives:
3. An old urine sample
4. Non-sterile urine containers (detergents, antiseptics, and cleaning agents can affect results)
5. Highly buffered alkaline urine (from medications, supplements, or vegetarian diets)
6. Dipstick left in the urine sample too long (dip for 1–2 seconds only)
7. Certain medications and substances (e.g., phenazopyridine, polyvinylpyrrolidone, chlorhexidine gluconate)
8. The presence of blood or high levels of bilirubin
9. Highly pigmented or concentrated urine
10. Contamination of urine with vaginal discharge, semen, heavy mucus, pus, or blood
11. 
    Possible causes of false negatives:
12. Very dilute urine sample
13. Proteins other than albumin (the dipsticks are more sensitive to albumin)

1. COLOR CHART & INTERPRETATION
   A positive dipstick test for protein will result in a pad color that is bright green, sea green, turquoise, or dark green. The intensity of the color of the reagent pad will correlate with the protein concentration in the urine. Use the following color key to interpret your test results:
   Color Level
   Concentration
   Negative
   None detected
   +/- Trace
   0.3 g/L = 30 mg/dL = 300 mg/L
   1+
   1.0 g/L = 100 mg/dL = 1,000 mg/L
   2+
   3.0 g/L = 300 mg/dL = 3,000 mg/L
   3+
   ≥ 20 g/L = ≥ 2,000 mg/dL = ≥ 20,000 mg/L
   1 g = 1000 mg, 1 L = 10 dL
   
   What do the results mean?
   A normal amount of protein in the urine is less than 150 milligrams (mg) per day. If you have more than 150 mg of protein in your urine per day, it is generally considered proteinuria. If you have 3 to 3.5 grams of protein in the urine per day, it is generally considered nephrotic-range proteinuria.
   
   Persistently elevated levels of protein in the urine may be a sign of urological or nephrological disorders, such as kidney disease or kidney damage caused by other conditions. Occasionally, protein in urine is an early sign of chronic kidney disease (CKD), although you can have CKD and have normal levels of protein in your urine.
   
   You are encouraged to follow up with your local physician to learn more about treatment options.

1. Contact your local physician or transplant center for more information about kidney disease.

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