welcome欧洲杯(买球)官方网站-2024 European Cup

Cooperate with special single reagent strips to realize the quantitative detection of a series of immunoassay items.

Supports single or multiple biomarkers for simultaneous detection and quantitative detection of a series of immunoassays

Product Model：DFIA300

Detection channel: 3 channels

Detection principle: dry fluorescence immunoassay

Sample type and blood volume requirements: serum, plasma, whole blood; ≤100µl

Display: 8-inch touch screen

Result transmission: support LIS transmission results

Cooperate with special single reagent strips to realize the quantitative detection of a series of immunoassay items.

Cooperate with special single reagent strips to realize the quantitative detection of a series of immunoassay items.

Expected usage:

The reagent is used for clinical in vitro quantitative detection of Interleukin-6 (IL-6) content in human serum, plasma, or whole blood samples, and is mainly used clinically for auxiliary diagnosis of bacterial infectious diseases.

Clinical significance：

In the inflammatory response, IL-6 rises earlier than other indicators and lasts for a long time, so it can be used to assist in the early diagnosis of acute infection. Dynamic observation of IL-6 levels also helps to understand the progress of infectious diseases and the response to treatment.

Applicable departments: 

Laboratory department, emergency department, pediatrics/neonatology, infection department, respiratory department, neurology, surgery, cardiology, gastroenterology, oncology, ICU, CCU, etc.

Expected usage:

The reagent is used for clinical in vitro quantitative detection of C-reactive protein (CRP) content in human serum, plasma or whole blood. C-reactive protein is mainly used as a non-specific inflammation indicator.

Clinical significance:

Identify bacterial or viral infections and use it for dynamic observation of antibiotic efficacy. Monitor changes in the condition and postoperative infection. Disease course detection and prognosis judgment.

Applicable departments:

Laboratory department, emergency department, pediatrics/neonatology, infection department, respiratory department, neurology, surgery, cardiology, gastroenterology, oncology, ICU, CCU, etc.

Expected usage:

The reagent is used for clinical in vitro quantitative detection of procalcitonin (PCT) content in human serum, plasma, or whole blood samples, and is mainly used clinically for auxiliary diagnosis of bacterial infectious diseases.

Clinical significance: 

Assist in the differential diagnosis of severe bacterial infections, sepsis and multiple organ failure Evaluation of the degree of infection and prognosis Instruct the rational use of antibiotics and the monitoring of efficacy.

Applicable departments: 

Laboratory department, emergency department, pediatrics/neonatology, infection department, respiratory department, neurology, surgery, cardiology, gastroenterology, oncology, ICU, CCU, etc.

Expected usage:

The reagent is used for clinical in vitro quantitative detection of C-reactive protein and serum amyloid A content in human serum samples, mainly as non-specific inflammation indicators.

Clinical significance:

Differential diagnosis index for bacterial infection and viral infection

Applicable departments:

Laboratory department, emergency department, pediatrics/neonatology, infection department, respiratory department, neurology, surgery, cardiology, gastroenterology, oncology, ICU, CCU, etc.

Expected usage:

The reagent is used for clinical in vitro quantitative detection of procalcitonin (PCT) and Interleukin-6 (IL-6) content in human serum, plasma, or whole blood samples, PCT is mainly used in clinical diagnosis of bacterial infections. IL-6 is mainly used to monitor the immune status and inflammation of the body.

Clinical significance

Increasing the rate of early diagnosis of infection is a necessary test item for early warning and rapid diagnosis of sepsis and to guide the correct use of antibiotics.

Applicable departments:

Laboratory department, emergency department, pediatrics/neonatology, infection department, respiratory department, neurology, surgery, cardiology, gastroenterology, oncology, ICU, CCU, etc.

Expected usage:

The reagent is used for clinical in vitro quantitative detection of SAA content in human serum, mainly as a non-specific inflammation indicator.

Clinical significance: 

Sensitive indicators to identify viral infections, combined with CRP and blood routine testing, can be used for early differential diagnosis, dynamic observation of curative effects and guidance of medication. Differential diagnosis of infectious diseases in children.

Applicable departments:

Laboratory department, emergency department, pediatrics/neonatology, infection department, respiratory department, neurology, surgery, cardiology, gastroenterology, oncology, ICU, CCU, etc.

Successfully obtained in the EU CE access certification

Passed ISO13485 certification

Lp-PLA₂: an emerging biomarker of coronary heart disease

- Intravascular highly specific inflammatory factors

- Independent risk predictors of cardiovascular and cerebrovascular diseases

Lp-PLA₂ induces an increase in plaque instability, making the plaque fragile and ruptured, leading to thrombosis and ischemic stroke. In addition, high levels of Lp-PLA₂ predict increased instability of atherosclerotic plaques, more prone to rupture, and increased risk of cardiovascular and cerebrovascular malignant events.Schematic diagram of Lp-PLA₂ is shown in Figure 1.

Figure 1

Schematic diagram of Lp-PLA₂ and plaque stability

References:

The international recognition and importance of Lp-PLA₂ is gradually increasing, and it is recommended that Lp-PLA₂ be used in various aspects of cardiovascular and cerebrovascular diseases such as screening, differential diagnosis, risk assessment, treatment and prognosis.Guideline Recommendation Table is shown in Figure 2.

Figure 2

Lp-PLA₂ Guideline Recommendation Table

Clinical significance: 

-Dynamic monitor of the degree of inflammation in the vascular endothelium and atherosclerotic plaques

-Risk estimation for coronary heart disease and stroke

-Estimated risk of recurrence for various cardiovascular embolisms (stroke)

-Efficacy assessment , the decreased level of Lp-PLA₂ is positively correlated with the lipid-lowering effect of statins

Applicable departments: 

Cardiology, cardiac surgery, neurology, veteran department, endocrinology, laboratory department, physical examination center

Successfully obtained in the EU CE access certification

Passed ISO13485 certification

Acute coronary syndrome (ACS) is a major cause of morbidity and mortality worldwide, and it incurs huge healthcare expenditures [1-4]. In the United States alone, 683,000 discharge occurrences resulting from ACS were reported in 2009 [5,6]. Remarkably, 1,190,000 secondary discharges were associated with ACS, of which 829,000 were attributed to myocardial infarction (MI) alone [5,6]. ACS is caused by the sudden obstruction of a coronary artery. Early diagnosis and prompt treatment of ACS continues to be a diagnostic challenge in medicine, The highest risk of fatality occurs within the initial hours of onset of AMI. Thus, early diagnosis of cardiac ischemia is critical for the effective management of patients with AMI. Improper diagnosis of patients with chest pain often leads to inappropriate admission of patients without AMI and vice versa. In addition to clinical history, physical examination, accurate electrocardiogram findings and assessment of cardiac biomarkers have an important role in the early diagnosis of acute ischemia. 

A  marker of Myocardial Injury：

H-FABP: It is a small-molecule soluble protein that is abundant in the cytoplasm of myocardium, but when myocardial cells are damaged, it can be quickly released into the blood, leading to a sharp increase in the level of H-FABP in the blood high.H-FABP can be used as a predictive biomarker of mortality following acute coronary syndrome (ACS).

Clinical significance: 

Detection for the early diagnosis and risk stratification of acute myocardial infarction Myocardial infarction area estimation Differential diagnosis of chest pain Prognostic evaluation of ACS

Applicable departments: 

Cardiology, chest pain center, stroke center, emergency department, ICU, cardiac surgery, neurology, respiratory, etc.

Successfully obtained in the EU CE access certification

Passed ISO13485 certification

Acute coronary syndrome (ACS) is a major cause of morbidity and mortality worldwide, and it incurs huge healthcare expenditures [1-4]. In the United States alone, 683,000 discharge occurrences resulting from ACS were reported in 2009 [5,6]. Remarkably, 1,190,000 secondary discharges were associated with ACS, of which 829,000 were attributed to myocardial infarction (MI) alone [5,6]. ACS is caused by the sudden obstruction of a coronary artery. Early diagnosis and prompt treatment of ACS continues to be a diagnostic challenge in medicine, The highest risk of fatality occurs within the initial hours of onset of AMI. Thus, early diagnosis of cardiac ischemia is critical for the effective management of patients with AMI. Improper diagnosis of patients with chest pain often leads to inappropriate admission of patients without AMI and vice versa. In addition to clinical history, physical examination, accurate electrocardiogram findings and assessment of cardiac biomarkers have an important role in the early diagnosis of acute ischemia. 

Myocardial Injury Marker：

H-FABP: It is a small-molecule soluble protein that is abundant in the cytoplasm of myocardium, but when myocardial cells are damaged, it can be quickly released into the blood, leading to a sharp increase in the level of H-FABP in the blood high.H-FABP can be used as a predictive biomarker of mortality following acute coronary syndrome (ACS).

CTnI: It is a contractile protein that exists only in the myocardium. It is one of the three subunits of troponin complex (I, T, C), and combines with tropomyosin in the filaments of myofibrils to form actin.

Myo: Mainly present in the myocardium and skeletal muscle. When skeletal muscle and myocardium are damaged (acute myocardial infarction), excessive exercise and muscle diseases, myoglobin is released into the blood.The levels of MYO can therefore not be used as a single diagnostic marker, but in conjunction with the troponins or CK-MB. Thus, serum levels of MYO can be used to rule out, rather than diagnose, myocardial infarction (46).

CK-MB: a form of creatine kinase isoenzyme, which mainly exists in the myocardium. It is one of the important markers of myocardial injury and can effectively diagnose acute myocardial infarction.

Joint detection

The combined detection of the three items of myocardial infarction helps distinguish AMI patients in a timely and accurate manner, minimizes the damage, avoids missed diagnosis and misdiagnosis, and can win more precious time for timely rescue of patients with myocardial infarction.

Multi-index combined detection can improve the detection rate and accuracy of myocardial injury, reduce the missed diagnosis rate, and reduce doctor-patient disputes.

Clinical significance:

Combined detection for early diagnosis and risk stratification of acute myocardial infarction Myocardial infarction area estimation differential diagnosis of chest pain Prognostic evaluation of ACS

Applicable departments:

Cardiology, chest pain center, stroke center, emergency department, ICU, cardiac surgery, neurology, respiratory, etc.

Successfully obtained in the EU CE access certification

Passed ISO13485 certification

AMH: a marker for ovarian reserve

AMH is secreted by preantral follicles and small antral follicles in the ovary, and its level is directly related to the number of follicles in the ovary. Schematic model of AMH actions in the ovary that is shown in Figure 1. 

Figure 1

Schematic model of AMH actions in the ovary

AMH is an indicator familiar to experts in gynecological endocrinology and assisted reproductive technology and is commonly used in ovarian reserve, ovarian responsiveness prediction, and PCOS disease diagnosis. AMH is the earliest hormone to change with age and is therefore a more accurate predictor of ovarian reserve in women at an earlier stage.

ESHRE consensus on the definition of‘poor response’to ovarian stimulation for in vitro fertilization.

AMH had the best sensitivity and specificity for predicting ovarian response.(Figure 2)

Figure 2

Clinical significance: 

• Evaluation of ovarian reserve

• Prediction of reproductive ovarian reactivity

• Predicting menopause

• Auxiliary diagnosis of ovarian related diseases in women (PCOS/POI)

Applicable departments: 

Physical examination center, reproductive center, gynecology, oncology, pediatrics

References:

1.NICE Clinical Guideline 156, 2013

2.Visser JA.et,al. Nat Rev Endocrinol. 2012 Jan 10;8(6):331-41.

3.Fleming R.et,al.Reprod Biomed Online. 2015 Oct;31(4):486-96.

4.Dumont A.et,al. Curr Opin Endocrinol Diabetes Obes. 2018 Dec;25(6):377-384.

Successfully obtained in the EU CE access certification

Passed ISO13485 certification

→ Female reproduction

Inhibin B is secreted by the granulosa cells of small antral follicles in women and directly reflect ovarian reserve.

→ Male reproduction

Inhibin B is produced by Sertoli cells in males, and its level reflects the function of the entire testicular tissue . Inhibin B is the best and most direct marker for evaluating male spermatogenesis.

INH-B:a novel marker of spermatogenesis

Subfertility affects about 15% of all couples. Assessment of spermatogenesis has a central role in the evaluation of the subfertile couple. Recently, the serum inhibin B level has emerged as a sensitive endocrine marker of spermatogenesis. The serum inhibin B level has been shown to be associated with classical markers of spermatogenesis, particularly testicular histology, and to be the most accurate endocrine marker of spermatogenesis. Schematic representation of the hypothala-mic-pituitary-testis axis in adulthood that is shown in Figure 1. 

Figure 1

Schematic representation of the hypothala-mic-pituitary-testis axis in adulthood

Hypothalamic GnRH stimulates the pituitary secretion of FSH and LH. LH stimulates Leydig cells to produce testosterone (T). FSH and testosterone directly stimulate Sertoli cells, which in turn, regulate germ cell development. GnRH is under negative feedback control by testosterone, while pituitary secretion of LH and FSH is under feedback control by testosterone, and inhibin B causes selective inhibition of FSH production. Inhibin B is produced by Sertoli cells in interaction with specific germ cell types. GnRH = gonadotrophin-releasing hormone; FSH = follicle-stimulating hormone; LH = luteinising hormone. 

Clinical significance:

• Analysis of male infertility

• Application of Testicular Sperm Aspiration (TESE) in Assisted Reproductive Technology

• Auxiliary diagnosis of childhood precocious puberty

Applicable departments: 

Physical examination center, reproductive center, gynecology, oncology, pediatrics

References:

1.NICE Clinical Guideline 156, 2013.

2.Visser JA.et,al. Nat Rev Endocrinol. 2012 Jan 10;8(6):331-41.

3.Fleming R.et,al.Reprod Biomed Online. 2015 Oct;31(4):486-96.

4.Dumont A.et,al. Curr Opin Endocrinol Diabetes Obes. 2018 Dec;25(6):377-384.

5.Pierik FH.et,al.Ann Med. 2003;35(1):12-20.

Successfully obtained in the EU CE access certification

Passed ISO13485 certification

PG and G17 serum levels in combination with gastroscopy was a powerful approach to diagnosing early-stage GC.

Gastroscopy followed by examinations of biopsy specimens is the gold standard for diagnosing gastric cancer (GC). A disadvantage of this method is that it is invasive and causes discomfort and pain, making it an undesirable procedure for diagnostics.  Several attempts have been made to detect precancerous lesions and early-stage GC in high incidence areas by examining serum levels of pepsinogen (PG) and gastrin-17 (G17), which could offer an effective and non-invasive alternative to traditional gastroscopy for diagnosing GC.1–3 . Three Introductions to Stomach Function is shown in Figure 1.

Figure 1

Three Introductions to Stomach Function

PGI   Mainly secreted by chief cells and mucous neck cells of fundic glands. PGI was negatively correlated with atrophic gastritis in the fundus and corpus, and positively correlated with peptic ulcer.

PGII  It is secreted by all gastric glands and duodenum. PGII is positively correlated with gastric ulcer, duodenal ulcer and Hp infection.

PGR (PGI/PGII)  Decreased PGI and normal PGII: The progressive decrease of PGR is related to the progress of gastric mucosal atrophy and gastric fundus.

G17  is secreted by G cells in the gastric antrum, and there is a strict negative feedback mechanism with gastric acid level, which is negatively correlated with atrophic gastritis of the gastric antrum.

Clinical significance: 

- Screening for gastric ulcer, atrophic gastritis, and early gastric cancer

- Determination index of recurrence after gastric cancer resection

- Determination index for recurrence and cure of peptic ulcer

- Dynamic monitoring of individual gastric mucosal function

- Stomach Health Checkup for Physical Examination People

Applicable departments: 

Gastroenterology, oncology, physical examination center, surgery

Successfully obtained in the EU CE access certification

Passed ISO13485 certification

Acute kidney injury (AKI) refers to the abnormality of kidney structure and function (including abnormal blood, urine, histology and imaging examination) within 3 months of disease course. resulting in clinical syndromes with different clinical manifestations.

In recent years, some new and more sensitive biomarkers of AKI have been discovered in clinical and laboratory studies, which can not only diagnose AKI before serum creatinine rises, but also provide help for the etiological diagnosis of AKI.

NGAL        The best index for early diagnosis of acute kidney injury

CYS-C     The best endogenous index of glomerular filtration rate

β2-MG      Monitoring indicators of proximal tubule function

MAU         Sensitive indicator of early or mild kidney injury

Microalbuminuria (MAU)

MAU is the most sensitive and reliable diagnostic indicator for early detection of renal disease. When the kidney is damaged, the urinary albumin excretion rate exceeds the normal range, which reflects the damage of glomerular filtration function and renal tubular reabsorption function. Combined with the incidence, symptoms and medical history statement, it can be more accurate to diagnose the condition.

Clinical significance: 

- Important indicators for early diagnosis of hypertension and diabetic nephropathy

- Early indications of changes in the kidneys and cardiovascular system

- Auxiliary diagnosis for glomerular injury

- Surveillance of pregnancy-induced hypertensive kidney injury

Applicable departments: 

Nephrology, emergency, interventional, ICU, cardiology, surgery

Successfully obtained in the EU CE access certification

Passed ISO13485 certification

Acute kidney injury (AKI) refers to the abnormality of kidney structure and function (including abnormal blood, urine, histology and imaging examination) within 3 months of disease course. resulting in clinical syndromes with different clinical manifestations.

In recent years, some new and more sensitive biomarkers of AKI have been discovered in clinical and laboratory studies, which can not only diagnose AKI before serum creatinine rises, but also provide help for the etiological diagnosis of AKI.

NGAL        The best index for early diagnosis of acute kidney injury

CYS-C     The best endogenous index of glomerular filtration rate

β2-MG      Monitoring indicators of proximal tubule function

MAU         Sensitive indicator of early or mild kidney injury

β2 Microglobulin (β2-MG)

The synthesis rate of β2-MG in healthy people is very stable, and it is only decomposed and excreted by the kidneys, and is not affected by factors such as age, gender, and muscle. The increase of β2-MG in plasma reflects the impairment of glomerular filtration function or the increase of filtration load; the increase of β2-MG in urine indicates the increase of renal tubular damage or load.

Clinical application of blood β2-MG：

- For estimation of renal function disorders

 a. Assessment of renal impairment in hypertension and  diabetes

 b. Dynamic observation and diagnosis of renal transplant rejection

- Prognosis and therapeutic effect evaluation of malignant tumor diseases

- Autoimmune disease assessment and efficacy monitoring

Clinical application value of urinary β2-MG

- Sensitive and specific method for the diagnosis of proximal convoluted tubule damage

- For the identification of upper and lower urinary tract infections

- Used to determine rejection of kidney transplantation, and a marked increase is seen several days before rejection  

Applicable departments: 

Nephrology, emergency, interventional, ICU, cardiology, surgery

Successfully obtained in the EU CE access certification

Passed ISO13485 certification

Acute kidney injury (AKI) refers to the abnormality of kidney structure and function (including abnormal blood, urine, histology and imaging examination) within 3 months of disease course. resulting in clinical syndromes with different clinical manifestations.

In recent years, some new and more sensitive biomarkers of AKI have been discovered in clinical and laboratory studies, which can not only diagnose AKI before serum creatinine rises, but also provide help for the etiological diagnosis of AKI.

NGAL        The best index for early diagnosis of acute kidney injury

CYS-C     The best endogenous index of glomerular filtration rate

β2-MG      Monitoring indicators of proximal tubule function

MAU         Sensitive indicator of early or mild kidney injury

Cystatin C (CYS-C)

CYS-C is produced at a constant rate in the body and is almost completely filtered by the glomerulus. CYS-C in the blood is not affected by changes in inflammation, sex, muscle, and age, but its concentration varies with the glomerular filtration rate (GFR) changes.

Clinical significance: 

- Reflects the functional level of glomerular filtration

- Early diagnosis and condition monitoring of kidney disease

- Renal function monitoring in patients with kidney transplantation and chemotherapy

- Early prevention and diagnosis of early renal damage in AKI high-risk population

- Renal function assessment in patients with cirrhosis

Applicable departments: 

Nephrology, emergency, interventional, ICU, cardiology, surgery

Successfully obtained in the EU CE access certification

Passed ISO13485 certification

Acute kidney injury (AKI) refers to the abnormality of kidney structure and function (including abnormal blood, urine, histology and imaging examination) within 3 months of disease course. resulting in clinical syndromes with different clinical manifestations.

In recent years, some new and more sensitive biomarkers of AKI have been discovered in clinical and laboratory studies, which can not only diagnose AKI before serum creatinine rises, but also provide help for the etiological diagnosis of AKI.

NGAL        The best index for early diagnosis of acute kidney injury

CYS-C     The best endogenous index of glomerular filtration rate

β2-MG      Monitoring indicators of proximal tubule function

MAU         Sensitive indicator of early or mild kidney injury

Neutrophil Gelatinase-Associated  Lipocalin (NGAL)

NGAL is a member of the lipocalin family and normally maintains low levels in urine and blood. In the early stage (2h) of acute kidney injury (AKI), the level of NGAL in urine and blood increased significantly, and NGAL appeared before other indicators. Therefore, NGAL is one of the most effective biomarkers for the diagnosis of AKI, and its changes are earlier and more significant than traditional AKI diagnostic indicators.

Clinical significance: 

- The best index for early diagnosis of AKI

- Chronic kidney disease, early detection of diabetic nephropathy

- Early detection and prognostic evaluation of AKI complicated by various operations

- Prognostic evaluation of kidney injury complicated by renal transplantation

- Early diagnosis of cardiovascular disease patients and ICU patients complicated with renal disease

Applicable departments: 

Nephrology, emergency, interventional, ICU, cardiology, surgery