Outstanding Fob Diagnostic Test - QL Biotech's Rapid Micro-Albumin Detection

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QL Biotech proudly presents our state-of-the-art Fob Diagnostic Test, a rapid test device specially designed for the immediate detection of small existence of albumin (microalbuminuria) in urine samples. This Micro-Albumin Rapid Test Device, a champion of our product line, presents a significant indication of initial kidney dysfunction and plays a crucial role in early diagnosis and prevention. Microalbuminuria refers to the persistent presence of albumin in the urine, which, in regular quantities, are not typically detected in standard urine tests. This presence of albumin demonstrates an early warning sign of kidney disease, necessitating immediate medical intervention. Our Fob Diagnostic Test addresses this need, providing timely and efficient detection of microalbuminuria. The Fob Diagnostic Test distinguishes itself by its precision, reliability, and easy-to-use interface. It is an essential tool for quick preliminary screening, allowing medical professionals to expedite diagnosis and provide timely treatment. The design of this rapid test device adheres to the highest standards of quality and accuracy, ensuring that results are not just quick but also remarkably accurate.

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

A.Accuracy

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%

B.Reproducibility

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.Sensitivity

The Microalbumin test has a sensitivity of 20μg/mL urine.

D.Specificity

The 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.




With QL Biotech's Fob Diagnostic Test, medical practitioners can now take proactive measures in the early detection and prevention of potential kidney dysfunction. This rapid test device is the embodiment of our commitment to superior quality, innovation, and the advancement of medical science. We believe that early detection is a significant step towards prevention and timely treatment. Our Fob Diagnostic Test supports this belief, delivering fast, reliable results when you need them the most. Choose QL Biotech's Fob Diagnostic Test - because your health matters to us.

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