FAQ – QUESTIONS AND ANSWERS

REPORTING PRODUCT FAULTS

Our quality department checks and controls each lot of our products always before delivery. Nevertheless, it cannot be completely guaranteed that the products out of any reason will show a defective.

We work continuously on the optimization of our quality controls. If you would like to provide us with feedback and suggestions, we will promptly check your information and investigate the cause of the problem.

COMPLAINT PROCEDURE

Please report a potential product malfunction straight away directly by sending an e-mail to “COMPLAINTS@pharmact.eu“. We require the following information, so that we can process your report immediately. Please provide the following details:

  • the product name, and
  • the LOT Number, production date
  • the PNN / GTIN of the product, and
  • the retailer of the article.

BelDIA PRE

Use of the Point-of-Care Test

The product BelDIA PRE is a rapid visual immunoassay for the qualitative detection of intact proinsulin in human whole blood, serum or plasma samples. It is intended for the early detection of a diabetes mellitus.

What is the accuracy of the test?

Intaktes Proinsulin
   Rel. Sensitivity 89,90%
   Rel. Specifivity 91,00%
   Accuracy 90,70%

What is the false positive rate of the test?

The false positive rate is about 9%. About 9% of the tests display a result that is clearly visible to the eyes, even though there is still no significant increase in intact proinsulin above 15 pmol/l.

Storage and shelf life

Storage and transport must take place in a temperature range between 2 – 30° C. Then the shelf life of the test is max. 24 months.

What is the clinical background?

Before the blood sugar level increases measurably, there is a phase of several years in which the precursor of insulin, intact proinsulin, demonstrably increases in concentration in the blood.

Intact proinsulin in the blood is a highly specific laboratory indicator of ß-cell dysfunction. Various studies have shown that increasing the level of intact proinsulin in the blood enables a prognosis of developing type 2 diabetes by up to 5 years in the future.

Field of application

The test enables the early diagnosis of a pathological disorder of the sugar metabolism. Type 2 diabetes develops when the body cells become increasingly insensitive to insulin and insulin resistance increases.

 

BelFIBRO

Application of the test unit

The IVD product BelFIBRO is a visual rapid immunoassay for the qualitative detection of the biomarker YKL-40 in serum samples. The assay is an aid in the diagnostic of the different states of liver disease.

What is the accuracy of the test?

  YKL-40 (CHI3L1)
   Rel. Sensitivity 96,60%
   Rel. Specifitivity 93,40%
   Accuracy 95,00%

What is the false positive rate of the assay?

The false positive rate is at only 3.4%. In about 3.4% of all tests a positive value is seen, whereas in fact no significantly elevated liver values are present.

Storage and shelf-life

Storage and shipping have to be carried out within a temperature range between 2 – 30° C. In this case the shelf life of the test is max. 24 months.

What is the clinical background

Among the most common causes of liver diseases in the industrialized countries is the NAFL (non-alcoholic fatty liver disease). The regular use of medication will be toxic to the liver as well excessive use of alcohol.

NAFL, the non-alcoholic fatty liver, leads to increasing fattiness of the liver cells through toxic lipid metabolites. This leads to steatohepatitis, an inflammation that leads to fibrotic remodeling of the liver parenchyma via tissue loss and chronic repair processes.

Infections caused by pathogens such as hepatitis viruses A to E or parasitic diseases are the main cause of chronic liver disease in the rest of the world.

BelCARDIO

Application of the test unit

The BelCARDIO rapid test is a visual immunoassay for the qualitative detection of cardiac Troponin I (cTnI) and heart type fatty acid binding protein (hFABP) in human whole blood, serum or plasma samples.

What is the accuracy of the test?

hFABP: cTnI
   Rel. Sensitivity 98.4% 94.70%
   Rel. Specifitivity 94.3% 95.00%
   Accuracy 95.7% 94.90%

What is the false positive rate of the assay?

The false positive rate is at only 3.5%. In about 3.5 of 100 tests a positive value is seen, whereas in fact no significantly elevated liver values are present.

Storage and shelf-life

Storage and shipping have to be carried out within a temperature range between 2 – 30° C. In this case the shelf life of the test is max. 24 months.

What is the clinical background?

The cTnI is a protein found in the heart muscle. After damage to the heart muscle, cTnI is released into the bloodstream after 3-6 hours. The release of cTnI is similar to creatine kinase (CK-MB). While CK-MB returns to its normal level after 72 hours, cTnI remains elevated for 6-10 days, providing a larger window of time to detect heart damage. Because of its high specificity and sensitivity in myocardial tissue, cTnI has become a preferred biomarker for myocardial infarction. The detection limit in the test is 0.5 ng/ml.

In the acute phase of a myocardial infarction (after approx. 20 min), hFABP is also released from the heart muscle tissue. For this reason, this protein, in addition to cTnI, is very well suited to support the early detection of myocardial infarction. The detection limit in the test is 7 ng/ml.

Which diseases/clinical situations can possibly falsify the result of the test?

– hFABP is also present in small amounts in the skeletal muscle.

– Unusually strong physical activity (e.g. marathon running) can destroy skeletal muscle cells. Thereby hFABP is released into the blood.

– Kidney insufficiency: h-FABP is constantly released into the blood by the muscle system in minute quantities and washed out by the kidneys. If the kidneys can no longer fulfil this task sufficiently, the hFABP level can be increased.

– The presence of exceptionally high concentrations of heterophilic antibodies (cross-reaction possible) or rheumatic factors (RF), unstable angina pectoris, congestive heart failure and a recent bypass operation of the coronary arteries can have a false positive effect on the result.