Rapid Test Reagent of Ferritin with ISO - QL Biotech's Micro-Albumin Test Device
INTRODUCTION
The persistent appearance of small amounts of albumin (microalbuminuria) in urine could be the first indicator of a renal dysfunction. For persons with diabetes, a positive result could be the first indicator of a diabetic nephropathy. Without initiation of therapy, the amount of released albumin will increase (macroalbuminuria) and a renal insufficiency will occur.
In case of type-2 diabetes, the early diagnosis and therapy of diabetic nephropathy is especially important. In addition to the renal dysfunction, cardiovascular risks could occur.
At normal physiological conditions, small amounts of albumin are glomerular filtrated and tubular reabsorbed. The expulsion of 20μg/mL to 200μg/mL is characterized as microalbuminuria. In
addition to renal dysfunctions, albuminuria can be caused by physical training, infections of the urinary tract, hypertension, cardiac insufficiency and surgery. If the amount of albumin decreases after disappearance of these factors, the transient albuminuria is without any pathological reason.
Product Parameters
|
Product Name |
ALB Micro-Albumin Rapid Test Device |
ALB Micro-Albumin Rapid Test Strip |
|
Used for |
For professional in vitro diagnostic use only. |
|
|
Specimen |
Urine |
|
|
Packing |
25 tests/box , 1 test/polybag |
|
|
MOQ |
1000 tests |
|
|
Diverse Coopetation Modes |
OEM/ODM |
|
PERFORMANCE CHARACTERISTICS
The accuracy of the Microalbumin test was evaluated in comparison to a commercially available immunoassay at a cut-off of 20μg/mL. 100 urine samples, collected from volunteers, have been tested by both procedures with >98% agreement.
|
Method |
Other ALB Rapid Test |
Total Results |
||
|
ALB One Step Test Device |
Results |
Positive |
Negative |
|
|
Positive |
48 |
1 |
49 |
|
|
Negative |
1 |
50 |
51 |
|
|
Total Results |
49 |
51 |
100 |
|
|
% Agreement with this Rapid Test Kit |
97.96% |
98.04% |
98.00% |
|
The reproducibility of the Microalbumin test was evaluated at 4 different sites using blind controls. Of 50 samples with albumin concentrations <10μg/mL, all were determined negatives.
Of 50 samples with albumin concentrations >40μg/mL, all were determined positive.
C.SensitivityThe Microalbumin test has a sensitivity of 20μg/mL urine.
D.SpecificityThe specificity for the Microalbumin test was tested by adding various compounds that are likely to be present in urine. All compounds were prepared in normal human urine with low amounts of albumin.
Consistency in these small quantities of albumin in urine, also known as microalbuminuria, is often the primary red flag in identifying renal dysfunctions. It is particularly crucial in detecting kidney ailments in individuals with diabetes. It's often seen as the earliest sign of diabetic kidney disease, which, if detected early, can significantly improve the quality of life for the patient. The Rapid Test Reagent of Ferritin with ISO in our ALB Micro-Albumin Rapid Test Device/Strip is designed to make this detection process quicker, simpler, and more accurate. In conclusion, our ALB Micro-Albumin Rapid Test Device/Strip encapsulates QL Biotech's commitment to sustainable health solutions. Leverage the trust and reliability in our ISO-certified Rapid Test Reagent of Ferritin to effectively detect renal dysfunction at its earliest stage. Be proactive about your health with QL Biotech's quality assurance and advanced bio-tech innovations.