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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.

Clinical significance：

The combined test can effectively help clinicians to quickly determine or rule out diseases that cause acute chest pain with dyspnea, and provide early risk stratification and determination of patients, thus helping doctors to diagnose the condition.

Main clinical applications：

1. Differential diagnosis and risk stratification of acute chest pain;

2. Early auxiliary diagnosis of AMI;

3. Assessment of heart failure conditions;

4.Dynamic detection of disease changes.

Applicable departments: 

Emergency Medicine, Cardiology, Cardiac Surgery, ICU, Geriatrics, Infectious Diseases, Physical Examination Center

Sample type：plasma and whole blood

Report time：12min

Reference range：cTnI≤0.3 ng/mL;CK-MB≤5 ng/mL;Myo≤58 ng/mL;D-Dimer＜0.5 mg/L;NT-proBNP（under 75 :＜300 pg/mL; 75 and over:＜450 pg/mL）

Storage：4-30℃，sealed and kept away from light and dry

Validity period：18months

Specifications：25 tests/box，50 tests/box

Successfully obtained in the EU CE access certification.

Clinical significance：

The combined test can effectively help clinicians to quickly determine or rule out diseases that cause acute chest pain with dyspnea, and provide early risk stratification and determination of patients, thus helping doctors to diagnose the condition.

Main clinical applications：

1.Rapid identification of high-risk chest pain and differentiation of dyspnea of cardiac and pulmonary origin;

2.Differential diagnosis of aortic coarctation disease and risk stratification of patients.

Applicable departments: 

Cardiology, Cardiac Surgery, Emergency, ICU.

Sample type：plasma and whole blood

Report time：15min

Reference range：cTnI≤0.3 ng/mL;D-Dimer＜0.5 mg/L;NT-proBNP（under 75 :＜300 pg/mL; 75 and over:＜450 pg/mL）

Storage：4-30℃，sealed and kept away from light and dry

Validity period：18months

Specifications：25 tests/box，50 tests/box

Successfully obtained in the EU CE access certification.

Clinical significance：

Clinically, it is mainly used as an aid in the diagnosis of myocardial infarction .

Main clinical applications：

1.Mainly used to assist in the early diagnosis of acute myocardial infarction and improve the early diagnosis rate；

2.Prognostic assessment of acute coronary syndromes.

Applicable departments: 

Cardiology, Cardiac Surgery, Emergency, ICU.

Sample type：serum, plasma and whole blood

Report time：10min

Reference range：cTnI≤0.3 ng/mL;H-FABP ≤7ng/mL

Storage：4-30℃，sealed and kept away from light and dry

Validity period：18months

Specifications：25 tests/box，50 tests/box

Successfully obtained in the EU CE access certification.

Clinical significance：

MPO can be used as a biomarker for acute coronary syndromes, including unstable angina and myocardial infarction. Studies have shown that elevated MPO levels are independently associated with adverse vascular events (MACE) in patients with ACS.

Elevated levels of MPO are associated with increased susceptibility to coronary artery disease and can therefore be used as a predictor of cardiovascular disease (CVD) occurrence, progression and prognosis.

Main clinical applications：

1.Assisting in the early diagnosis of acute coronary syndromes;

2.Independent prediction of risk of cardiovascular disease due to atherosclerosis.

Applicable departments: 

Chest Pain Center, Cardiology, Geriatrics, Physical Examination Center, Neurology, etc.

Sample type：plasma, whole blood

Report time：10min

Reference range：≤100 ng/mL

Storage：4-30℃，sealed and kept away from light and dry

Validity period：18 months

Specifications：25 tests/box，50 tests/box

Successfully obtained in the EU CE access certification.

Clinical significance：

D-Dimer is mainly used to assess the functional status of the fibrinolytic system in vivo, and is used as an aid in the diagnosis and exclusion of thrombotic diseases and diffuse intravascular coagulation.

Main clinical applications：

1.Auxiliary diagnosis of disseminated intravascular coagulation;

2. Exclusionary diagnosis of lower extremity deep vein thrombosis and pulmonary embolism;

3. Auxiliary tumor screening and prognosis determination;

4. Monitoring of thrombolytic therapy.

Applicable departments: 

Vascular Surgery, Cardiology, Trauma Surgery, Obstetrics and Gynecology, Geriatrics, Endocrinology, Urology, ICU, Oncology, Hematology, Respiratory Medicine,etc.

Sample type：plasma, whole blood

Report time：15min

Reference range：＜0.5 mg/L

Storage：4-30℃，sealed and kept away from light and dry

Validity period：24 months

Specifications：25 tests/box，50 tests/box

Successfully obtained in the EU CE access certification.

Clinical significance：

Mainly used for cardiovascular disease risk prediction, auxiliary diagnosis of inflammatory diseases.

Main clinical applications：

1. Cardiovascular disease risk prediction;

2. Auxiliary diagnosis of infectious diseases;

3. Postoperative infection detection .

Applicable departments: 

Cardiology, Cardiac Surgery, ICU, Infection, Emergency, Outpatient, Medical Examination Center

Sample type：serum, plasma, whole blood

Report time：10min

Reference range：≤1 mg/L

Storage：4-30℃，sealed and kept away from light and dry

Validity period：18 months

Specifications：25 tests/box，50 tests/box

Successfully obtained in the EU CE access certification

Passed ISO13485 certification

ST2: a novel biomarker for heart failure

ST2 is a member of the interleukin-I（IL-1）receptor family. When the heart continues to be under pressure, the expression of ST2 increases, which indirectly promotes myocardial hypertrophy and myocardial fibrosis, affects cardiac function, and greatly increases the readmission and mortality of patients with heart failure.

ST2 is released when cardiomyocytes stretch, neutralizing its ligand IL-33 (1, 2). It is also associated with inflammation during the MI and HF (3). As a decoy receptor of IL-33 receptor (ST2L), an appropriate amount of sST2 can prevent uncontrolled inflammation. However, redundant sST2 could also block the advantageous biological effect of IL-33 due to its competitive role against ST2L, which will eventually cause HF (3). Recently, sST2 is frequently reported to be associated with CVDs, especially HF (5–6). The ST2 pathway in CVD is shown in Figure 1.

Figure 1

ST2 pathway in CVD

Biomarkers have made a significant contribution to the diagnosis and prognosis of disease. Although strongly associated with inflammatory and autoimmune diseases, ST2 has also been found to play a role in the diagnosis and prognosis of CVD (4, 7). As one of the isoforms of ST2, sST2 has recently become a promising prognostic indicator for patients diagnosed with HF and a useful tool for risk stratification (8). Due to its prognostic value, sST2 was recommended by the American College of Cardiology Foundation (ACC)/American Heart Association (AHA) as an important biomarker for monitoring HF patients in 2013 (9).

ST2 yielded strong, independent predictive value for all-cause and cardiovascular mortality, and HF hospitalization in chronic HF, and deserves consideration to be part of a multimarker panel together with NT-proBNP and hs-TnT.

Clinical significance: 

• Auxiliary diagnosis of heart failure

• For monitoring the efficacy of heart failure 

• For risk stratification and prognostic risk assessment of heart failure 

Applicable departments: 

Emergency department, cardiac surgery, cardiology, chest pain center, Clinical Laboratory, ICU, CCU.

References:

1. Weinberg EO, Shimpo M, De Keulenaer GW, MacGillivray C, Tominaga S, Solomon SD, et al. Circulation. (2002) 

3. Marino R, Magrini L, Orsini F, Russo V, Cardelli P, Salerno G, et al. Ann Lab Med. (2017) 

4. Oshikawa K, Kuroiwa K, Tago K, Iwahana H, Yanagisawa K, Ohno S, et al. Am J Respir Crit Care Med. (2001) 

5. Dudek M, Kałuzna-Oleksy M, Migaj J, Straburzyńska-Migaj E. Adv Clin Exp Med. (2020)

6. McCarthy CP, Januzzi JL, Jr. Soluble ST2 in Heart Failure. Heart Fail Clin. (2018) 

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Passed ISO13485 certification

Heart failure (HF) biomarkers have dramatically impacted the way HF patients are evaluated and managed. B-type natriuretic peptide (BNP) and N-terminal proBNP (NT-proBNP) are the gold standard biomarkers in determining the diagnosis and prognosis of HF, and studies on natriuretic peptide-guided HF management look promising. 

NT-proBNP: A gold standard for Heart Failure

International guidelines recommend the use of B-type natriuretic peptide testing in the diagnostic workup of Heart Failure (HF) in both acute and non-acute patient presentation(2).

In the emergency department (ED), NT-proBNP is particularly useful for the triage of patients with acute dyspnea and suspected acute HF. It is highly sensitive and specific for exclusion (single rule-out cut-off value of 300 pg/mL) or confirmation of acute HF (age-adjusted rule-in cut-off values) (3).

*The area between the rule-out (<300pg/mL) and the rule-in (age-ajusted) cut-off values is designated as the "gray zone".

NT-proBNP in the evaluation and triage of ED patients with acute dyspnea (4) 

In primary care, NT-proBNP is particularly useful to guide referral of symptomatic chronic HF to specialist care because it excludes suspected left ventricular systolic dysfunction. Compared with NT-proBNP values in patients with acute HF, lower values are expected in ambulatory chronic HF patients. International guidelines recommend a single low cut-off of 125pg/mL to rule out HF for patients presenting with non-acute symptoms. However peer-reviewed literature supports the use of age-dependent cut-offs to adjust for loss of specificity in such settings(5).

NT-proBNP in the primary care setting 

Clinical significance:

Early elimination/diagnosis of heart failure, identification of causes of acute and chronic dyspnea Risk classification of patients with heart failure, prediction of adverse outcomes Efficacy monitoring, treatment guidance and prognosis evaluation for patients with heart failure

Applicable departments:

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

References:

1. Moe G.W, Howlett J, Januzzi JL, et al.  Primary results of the Canadian prospective randomized multicenter IMPROVE-CHF study. Circulation 2007;115: 3103-3110.
2. McMurray JJ, Adamopoulos S, Anker SD, et al.; ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure 2012: Eur Heart J. 2012;33:1787-847
3. Januzzi JL, van Kimmenade R, et al. the International Collaborative of NT-proBNP Study. Eur Heart J. 2006 ;27:330-7.
4. Januzzi JL, Chen-Tournoux AA, Moe G. Am J Cardiol. 2008;101 (Suppl.):29A-38A.
5. Hildebrandt P, Collinson PO, et al. Eur Heart J. 2010;31:1881-9.

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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.

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→ 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.

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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.

Clinical significance：

PGII is mainly a marker of gastric body atrophic gastritis, which is elevated in inflammation and decreases significantly in atrophic gastritis, precancerous lesions or gastric cancer, and is negatively correlated with gastric body atrophic gastritis.

PGII is mainly a marker of gastric inflammation, including gastric ulcer, duodenal ulcer, Helicobacter pylori (Hp) infection, PGII is significantly elevated in inflammation, positively correlates with gastric inflammation, and has a characteristic: it maintains a high level after elevation, and does not decrease significantly in atrophic gastritis, precancerous lesions or gastric cancer.

Main clinical applications：

1.For primary screening of gastric cancer and gastric diseases;

2.Evaluation of Hp and Eradication Treatment Effectiveness;

3.Screening for peptic ulcers.

Applicable departments: 

Endoscopy Center, Gastroenterology, Physical Examination Center, etc.

Sample type：serum, plasma and whole blood

Report time：10min

Reference range：PGI ＞70ng/mL; PGII ＜15ng/mL

Storage：4-30℃，sealed and kept away from light and dry

Validity period：18months

Specifications：25 tests/box，50 tests/box

Successfully obtained in the EU CE access certification.

Clinical significance：

Changes in the concentration of G-17 can be used to identify different types of atrophic gastritis.Elevated levels of G-17 are suggestive of atrophic gastritis in the elderly, gastric cancer, atrophic gastric body gastritis, functional dyspepsia in the elderly, and duodenal bulb ulcers.

Decreased G-17 levels suggestive of atrophic gastric sinus gastritis, multifocal atrophy of the whole stomach.

Main clinical applications：

1. Responds to high or low stomach acid;

2.Suggests the location, extent and risk of gastric mucosal atrophy;

3.Guidance on the rational use of medications, such as proton pump preparations (PPIs) and nonsteroidal anti-inflammatory drugs (NSAIDs).

Applicable departments: 

Endoscopy Center, Gastroenterology, Physical Examination Center, etc.

Sample type：serum, plasma and whole blood

Report time：10min

Reference range：1 pmol/L-7 pmol/L

Storage：4-30℃，sealed and kept away from light and dry

Validity period：24months

Specifications：25 tests/box，50 tests/box

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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

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

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

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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

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

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Clinical significance：

 CYS-C is mainly used as an indicator of glomerular filtration rate, CYS-C is a sensitive indicator for detecting renal injury and is widely used in clinical assessment of renal function .

Main clinical applications：

1.Renal function assessment in diabetic nephropathy and hypertensive nephropathy;

2.Supportive diagnosis of Acute Kidney Injury;

3.Supportive diagnosis of nephropathy in children.

Applicable departments: 

Urology, Nephrology, Physical Examination Center, etc.

Sample type：serum, plasma and whole blood

Report time：5min

Reference range：0.5 mg/L-1.1 mg/L

Storage：4-30℃，sealed and kept away from light and dry

Validity period：18months

Specifications：25 tests/box，50 tests/box

Successfully obtained in the EU CE access certification.

Clinical significance：

S100β is a specific marker for brain injury, which is rapidly released into the blood when brain injury occurs, causing an increase in S100β level. Detecting S100β level in the blood can help doctors to detect brain injury at an early stage, assess the degree of injury and judge the prognosis, which is of great significance in improving the prognosis of patients and reducing the economic burden.

Main clinical applications：

1. Early diagnosis, severity and prognosis assessment of brain injury;

2. Early diagnosis of stroke (cerebral infarction and cerebral hemorrhage), assessment of the degree of brain damage and prognosis;

3. Early diagnosis of central nervous system infections (meningitis), disease assessment and treatment monitoring;

4. Early diagnosis and assessment of brain damage caused by various types of neonatal encephalopathies.

Applicable departments: 

Neurology, Neurosurgery, Neonatology, Pediatrics, Geriatrics, Emergency, Cardiology, Surgery,etc

Sample type：serum, plasma, whole blood

Report time：10min

Reference range：＜0.2 ng/mL

Storage：4-30℃，sealed and kept away from light and dry

Validity period：18 months

Specifications：25 tests/box，50 tests/box