TECHNICAL SPECIFICATION
Cardiac Markers
· Cardiac Troponin I(Immunofluorescence)
Simple, easy to use
– Fast, results in 15 minutes
– Easy to read results
– Use whole blood, serum or plasma
– Room temperature storage
Basic information’s
Cardiac Troponin I Fast Test Kit (Immunofluorescence Assay) is intended for use together with CIA-1000 Immunofluorescence Quantitative Analyzer
to quantitatively determine the concentrations of cTnI in human serum, plasma, or whole blood specimens in Point-of Care and laboratory settings. The test uses the fluorescent conjugated anti-human cTnI monoclonal antibody to detect any cTnI appeared in blood samples. The fluorescence intensity of the test line increases proportionally to the amount of cTnI in a sample.
Then insert test card into CIA-1000. The concentration of cTnI in a sample will be determined and displayed on the screen. The value will be stored in CIA-1000 and available for downloading. The result can be easily transmitted to the laboratory or hospital information system.
Detection Method: fluorescent dye, a quantitative test for use with the CIA-1000 Immunofluorescence Quantitative Analyzer
Sample Type: plasma or whole blood in Heparin, serum.
Reaction Time: yields results in about 15 minutes.
Storage Temperature: 4-30°C
Storage Life: 24 months. Use the test card within 1 hour once the foil bag is opened
Clinical Application
The test is intended to detect Cardiac Troponin I (cTnI) quantitatively thus helping the detection and evaluation of myocardial injury. The test can be used for the early diagnosis of Acute Myocardial Infarction (AMI), Unstable Anagina, Acute Myocarditis and Acute Coronary Syndrome(ACS).
NT-proBNP(Immunofluorescence)
– Simple, easy to use
– Fast, results in 10 minutes
– Easy to read results
– Use whole blood, serum or plasma
– Room temperature storage
- NT-proBNP Fast Test Kit (Immunofluorescence Assay)
- is intended for use together with CIA-1000 Immunofluorescence Quantitative Analyzer
to quantitatively determine the concentrations of NT-proBNP in human serum, plasma, or whole blood specimens in Point-of Care and laboratory settings. The test uses the fluorescent conjugated anti-human NT-proBNP monoclonal antibody to detect any NT-proBNP appeared in blood samples. The fluorescence intensity of the test line increases proportionally to the amount of NT-proBNP in a sample.
- Then insert test card into CIA-1000. The concentration of NT-proBNP in a sample will be determined and displayed on the screen. The value will be stored in CIA-1000 and available for downloading. The result can be easily transmitted to the laboratory or hospital information system.
- Detection Method:fluorescent dye, a quantitative test for use with the CIA-1000 Immunofluorescence Quantitative Analyzer
- Detection Range:100–35000 pg/ml
- Cut-off Value:300 pg/ml
- Sample Type:plasma or whole blood in Heparin, serum.
- Reaction Time:yields results in about 10 minutes.
- Storage Temperature:4-30°C
- Storage Life: 24 months. Use the test card within 1 hour once the foil bag is opened.
- Package
- 1) For CIA-1000
- A box package contains 25 tests:
Foil bag, which contains one test card and one desiccant |
25
|
Disposable pipet |
25
|
Manual |
1
|
SD card |
1 |
Whole blood buffer |
1
|
Clinical Application:
- Early detection for patients with heart failure;
- Diagnosis and risk stratification of heart failure;
- Distinguishing dyspnea caused by heart failure from other diseases;
- Monitoring and prognostic assessment of heart failure treatment;
- Screening and diagnosis for non-cardiac heart failure patients;
- As an aid in the risk stratification for ACS.
CK-MB/cTnI/Myo(Immunofluorescence)
–Simple, easy to use
– Fast, results in 15 minutes
– Easy to read results
– Use whole blood, serum or plasma
– Room temperature storage
CK-MB/cTnI/Myo Fast Test Kit (Immunofluorescence Assay)
is intended for use together with CIA-1000 Immunofluorescence Quantitative Analyzer
to quantitatively determine the concentrations of CK-MB/cTnI/Myo in human serum, plasma, or whole blood specimens in Point-of Care and laboratory settings. The test uses the fluorescent conjugated anti-human MB/cTnI/Myo monoclonal antibodies to detect any CK-MB/cTnI/Myo appeared in blood samples. The fluorescence intensity of each test line increases proportionally to the amount of CK-MB/cTnI/Myo in a sample.
Then insert test card into CIA-1000. The concentration of CK-MB/cTnI/Myo in a sample will be determined and displayed on the screen. The value will be stored in CIA-1000 and available for downloading. The result can be easily transmitted to the laboratory or hospital information system.
Detection Method: fluorescent dye, a quantitative test for use with the CIA-1000 Immunofluorescence Quantitative Analyzer
Sample Type: plasma or whole blood in Heparin, serum.
Reaction Time: yields results in about 15 minutes.
Storage Temperature: 4-30°C
Storage Life: 24 months. Use the test card within 1 hour once the foil bag is opened.
Package
1) For CIA-1000
A box package contains 25 tests:
Foil bag, which contains one test card and one desiccant |
25 |
Disposable pipet |
25 |
Manual |
1 |
SD card |
1 |
Whole blood buffer |
1 |
Department |
Patient
|
Clinical Application
|
Cardiology |
Chest pain or Chest discomfort |
Differential diagnosis of chest pain; Detection of myocardial damage, Evaluating the area of myocardial ischemia; |
Emergency |
Myocarditis Myocardial trauma |
Diagnosis, risk stratification and prognosis of ACS; Monitoring the clinical curative effect of therapeutic drug; |
Clinical Laboratory |
Congestive heart failure |
The assessment of left ventricular function. |
Paediatrics |
Leukemi, Surgery, Congenital heart disease |
Monitoring the myocardial damage caused by chemotherapy or surgery |
Hematology
Oncology |
Chemotherapy |
Monitoring the cardiac toxicity damage caused by chemotherapeutic drugs |
Urology |
End-stage renal disease (ESRD) Renal transplatation |
Monitoring the myocardial damage caused by ESRD; detection before renal transplantation |
Surgery |
Cardiac surgey |
Monitoring the myocardial damage in peroperative period |
Other Departments |
Shock, Anemia, Acidosis or other Dysfunctions |
Monitoring the acute myocardial damage caused by disease or external factors |
NT-proBNP/cTnI(Immunofluorescence)
– Simple, easy to use
– Fast, results in 15 minute
– Easy to read results
– Use whole blood, serum or plasma
– Room temperature storage
NT-proBNP/cTnI Fast Test Kit (Immunofluorescence Assay):
is intended for use together with CIA-1000 Immunofluorescence Quantitative Analyzer
to quantitatively determine the concentrations of NT-proBNP/cTnI in human serum, plasma, or whole blood specimens in Point-of Care and laboratory settings. The test uses the fluorescent conjugated anti-human NT-proBNP/cTnI monoclonal antibodies to detect any NT-proBNP /cTnI appeared in blood samples. The fluorescence intensity of the test line increases proportionally to the amount of NT-proBNP/cTnI in a sample.
Then insert test card into CIA-1000. The concentration of NT-proBNP/cTnI in a sample will be determined and displayed on the screen. The value will be stored in CIA-1000 and available for downloading. The result can be easily transmitted to the laboratory or hospital information system.
Detection Method: fluorescent dye, a quantitative test for use with the CIA-1000 Immunofluorescence Quantitative Analyzer
Sample Type: plasma or whole blood in Heparin, serum.
Reaction Time: yields results in about 15 minutes.
Storage Temperature:4-30°C
Storage Life: 24 months. Use the test card within 1 hour once the foil bag is opened.
Package
1) For CIA-1000
A box package contains 25 tests:
Foil bag, which contains one test card and one desiccant |
25 |
Disposable pipet |
25 |
Manual |
1 |
SD card |
1 |
Whole blood buffer |
1 |
Clinical Applications:
Combined determination of NT-proBNP and cTnI could be used for diagnosis, prognosis and risk stratification of Heart Failure (HF) and Acute Coronary Syndrome(ACS), showing great clinical significances.
D-Dimer(Immunofluorescence)
– Simple, easy to use
– Fast, results in 10 minutes
– Easy to read results
– Use whole blood, plasma
– Room temperature storage
Basic Information’s:
D-Dimer Fast Test Kit (Immunofluorescence Assay)is intended for use together with CIA-1000 Immunofluorescence Quantitative Analyzer
to quantitatively determine the concentrations of D-Dimer in human plasma, or whole blood specimens in Point-of Care and laboratory settings. The test uses the fluorescent conjugated anti-human D-Dimer monoclonal antibodies to detect any D-Dimer appeared in blood samples. The fluorescence intensity of the test line increases proportionally to the amount of D-Dimer in a sample.
Then insert test card into CIA-1000. The concentration of D-Dimer in a sample will be determined and displayed on the screen. The value will be stored in CIA-1000 and available for downloading. The result can be easily transmitted to the laboratory or hospital information system.
Detection Method: fluorescent dye, a quantitative test for use with the CIA-1000 Immunofluorescence Quantitative Analyzer
Detection Range: 0.1-10.0 mg/L
Cut-off Value: 0.5 mg/L
Sample Type: plasma or whole blood in Sodium Citrate.
Reaction Time: yields results in about 10 minutes.
Storage Temperature: 4-30°C
Storage Life: 24 months. Use the test card within 1 hour once the foil bag is opened.
Package
1) For CIA-1000
A box package contains 25 tests:
Foil bag, which contains one test card and one desiccant |
25 |
Disposable pipet |
25 |
Manual |
1 |
SD card |
1 |
Sample diluent |
25 |
Clinical Applications:
- As an aid in the exclusion of venous thromboembolism (VTE);
- As an aid in the exculsion of pulmonary embolism(PE);
- As an aid in the diagnosis of disseminated intravascular coagulation (DIC);
- As an aid in the diagnosis and prognosis of cerebral infarction;
- As an aid in the evaluation of coagulation status of pregnancy-induced hypertension;
- As an aid in the diagnosis and prognosis of patients with surgery; monitor the thrombolytic therapy.
Renal Function:
Cystatin C(Immunofluorescence)
– Simple, easy to use
– Fast, results in 3 minutes
– Easy to read results
– Use whole blood, serum or plasm
– Room temperature storage
Basic Informations:
CysC Fast Test Kit (Immunofluorescence Assay) is intended for use together with CIA-1000 Immunofluorescence Quantitative Analyzer to quantitatively determine the concentrations of CysC in human plasma, serum or whole blood specimens in Point-of Care and laboratory settings. The test uses the fluorescent conjugated anti-human CysC monoclonal antibodies to detect any CysC appeared in blood samples. The fluorescence intensity of the test line increases proportionally to the amount of CysC in a sample.
Then insert test card into CIA-1000. The concentration of CysC in a sample will be determined and displayed on the screen. The value will be stored in CIA-1000 and available for downloading. The result can be easily transmitted to the laboratory or hospital information system.
Detection Method: fluorescent dye, a quantitative test for use with the CIA-1000 Immunofluorescence Quantitative Analyzer
Detection Range: 0.5-10.0 mg/L
Expected range of value: 0.51 mg/L~1.09 mg/L
Sample Type: plasma or whole blood in Sodium Citrate/EDTA, serum.
Reaction Time: yields results in about 3 minutes.
Storage Temperature: 4-30°C
Storage Life: 24 months. Use the test card within 1 hour once the foil bag is opened.
Package
1) For CIA-1000
A box package contains 25 tests:
Foil bag, which contains one test card and one desiccant |
25 |
Disposable pipet |
25 |
Manual |
1 |
SD card |
1 |
Sample diluent |
25 |
Clinical Applications:
- Early diagnosis of kidney disease;
- Renal function monitoring of renal transplant patients and chemotherapy;
- Prevention and early diagnosis of renal damage in high risk population of AKI;
- Eveluation of renal function in liver cirrhosis
β2-MG(Immunofluorescence):
– Simple, easy to use
– Fast, results in 3 minutes
– Easy to read results
– Use whole blood, serum or plasma
– Room temperature storage
Basic Informations
β2-MG Fast Test Kit (Immunofluorescence Assay)is intended for use together with CIA-1000 Immunofluorescence Quantitative Analyzer
to quantitatively determine the concentrations of β2-MG in human serum, plasma, or whole blood specimens in Point-of Care and laboratory settings. The test uses the fluorescent conjugated anti-human
β2-MG monoclonal antibody to detect any β2-MG appeared in blood samples. The fluorescence intensity of the test line increases proportionally to the amount of β2-MG in a sample.
Then insert test card into CIA-1000. The concentration of β2-MG in a sample will be determined and displayed on the screen. The value will be stored in CIA-1000 and available for downloading. The result can be easily transmitted to the laboratory or hospital information system.
Detection Method: fluorescent dye, a quantitative test for use with the CIA-1000 Immunofluorescence Quantitative Analyzer
Detection Range: 0.5–20.0 mg/L
Expected range of value: 0.8 mg/L~3.0 mg/L
Sample Type: plasma or whole blood in Sodium Citrate/EDTA, serum.
Reaction Time: yields results in about 3 minutes.
Storage Temperature:4-30°C
Storage Life: 24 months. Use the test card within 1 hour once the foil bag is opened
Package
1) For CIA-1000
A box package contains 25 tests:
Foil bag, which contains one test card and one desiccant |
25 |
Disposable pipet |
25 |
Manual |
1 |
SD card |
1 |
Sample diluent |
25 |
Clinical Applications:
1.Evaluation of the kidney disease
2.Assessing the hypertension and kidney injury casued by diabetic nephropathy (DN)
3.The evaluation for prognosis and therapeutic effect of malignancies
4.Posttransplantation lymphoproliferative disease(PTLD)
5.Glomerular filtration function;
6.Dynamic observation and diagnosis of the kidney transplant rejection;
7.Multiple myeloma.
NGAL (Immunofluorescence)
– Simple, easy to use
– Fast, results in 10 minutes
– Easy to read results
– Use whole blood, serum, plasma or urine;
– Room temperature storage
NGAL Fast Test Kit (Immunofluorescence Assay)is intended for use together with CIA-1000 Immunofluorescence Quantitative Analyzer
to quantitatively determine the concentrations of NGAL in human urine specimen in Point-of Care and laboratory settings. The test uses the fluorescent conjugated anti-human NGAL polyclonal antibodies to detect any NGAL appeared in urine samples. The fluorescence intensity of the test line increases proportionally to the amount of NGAL in a sample.
Then insert test card into CIA-1000. The concentration of NGAL in a sample will be determined and displayed on the screen. The value will be stored in CIA-1000 and available for downloading. The result can be easily transmitted to the laboratory or hospital information system.
Package
1) For CIA-1000
A box package contains 25 tests:
Foil bag, which contains one test card and one desiccant |
25 |
Disposable pipet |
25 |
Manual |
1 |
SD card |
1 |
Sample diluent |
25 |
Clinical Applications:
1.An early diagnostic marker for Acute Kidney Injury (AKI)
2.Diagnosis and warning for chronic kidney disease (CKI)
3.Monitoring the treatment effect and assessment of Lesion extent
4.Tissue specificity in neoplastic diseases
5.Associate with the development and occurance of CVD.
mAlb(Immunofluorescence)
– Simple, easy to use
– Fast, results in 3 minutes
– Easy to read results
– Use urine
– Room temperature storage
- Basic Informations:
- mAlbFast Test Kit (Immunofluorescence Assay)is intended for use together with CIA-1000 Immunofluorescence Quantitative Analyzer
to quantitatively determine the concentrations of mAlb in human urine specimen in Point-of Care and laboratory settings. The test uses the fluorescent conjugated anti-human mAlb polyclonal antibodies to detect any mAlb appeared in urine samples. The fluorescence intensity of the test line increases proportionally to the amount of mAlb in a sample.
- Then insert test card into CIA-1000. The concentration of mAlb in a sample will be determined and displayed on the screen. The value will be stored in CIA-1000 and available for downloading. The result can be easily transmitted to the laboratory or hospital information system.
- Detection Method:fluorescent dye, a quantitative test for use with the CIA-1000 Immunofluorescence Quantitative Analyzer
- Detection Range:0-200.0 mg/L
- Cut-off Value:0 mg/L
- Sample Type:
- Reaction Time:yields results in about 3 minutes.
- Storage Temperature: 4-30°C
- Storage Life: 24 months. Use the test card within 1 hour once the foil bag is opened
Package
A box package contains 25 tests
Foil bag, which contains one test card and one desiccant |
25 |
Disposable pipet |
25 |
Manual |
1 |
SD card |
1 |
Clinical Applications:
- Indicator of Diabetic nephropathy, hypertensive nephropathy and early renal damage;
- An early indicator of changes in renal and cardiovascular system;
- Detection of Pregnancy-induced renal disease;
- An important indicator in diagnosing glomerular injury.
Diabetes Care
HbA1c(Immunofluorescence)
– Simple, easy to use
– Fast, results in 5 minutes
– Easy to read results
– Use whole blood
– Room temperature storage
Basic Informations:
HbA1c Fast Test Kit (Immunofluorescence Assay)is intended for use together with CIA-1000 Immunofluorescence Quantitative Analyzer
to quantitatively determine the concentrations of HbA1c in human whole blood specimens in Point-of Care and laboratory settings. The test uses the fluorescent conjugated anti-human HbA1c monoclonal antibody to detect any HbA1c appeared in blood samples. The fluorescence intensity of the test line increases proportionally to the amount of HbA1c in a sample.
Then insert test card into CIA-1000. The concentration of HbA1c in a sample will be determined and displayed on the screen. The value will be stored in CIA-1000 and available for downloading. The result can be easily transmitted to the laboratory or hospital information system.
Detection Method: fluorescent dye, a quantitative test for use with the CIA-1000 Immunofluorescence Quantitative Analyzer
Detection Range: 2~14%
Expected Range of Value: 3.8~5.8%
Sample Type: whole blood in Heparin/Sodium Cireate/EDTA.
Reaction Time: yields results in about 5 minutes.
Storage Temperature: 4-30°C
Storage Life: 24 months. Use the test card within 1 hour once the foil bag is opened.
Package
1) For CIA-1000
A box package contains 25 tests:
Foil bag, which contains one test card and one desiccant |
25 |
Disposable pipet |
25 |
Manual |
1 |
SD card |
1 |
Sample diluent |
25 |
Clinical Applications:
This test is used as an aid for monitoring glycemic control in diabetics, In addition, it can identify people at risk of developing the disease and ongoing monitoring.
Inflammatory Markers:
PCT (Immunofluorescence )
– Simple, easy to use
– Fast, results in 15 minutes
– Easy to read results
– Use whole blood, serum or plasma
– Room temperature storage
Basic Informations:
PCT Fast Test Kit (Immunofluorescence Assay)is intended for use together with CIA-1000 Immunofluorescence Quantitative Analyzer
to quantitatively determine the concentrations of PCT in human serum, plasma, or whole blood specimens in Point-of Care and laboratory settings. The test uses the fluorescent conjugated anti-human PCT monoclonal antibody to detect any PCT appeared in blood samples. The fluorescence intensity of the test line increases proportionally to the amount of PCT in a sample.
Then insert test card into CIA-1000. The concentration of PCT in a sample will be determined and displayed on the screen. The value will be stored in CIA-1000 and available for downloading. The result can be easily transmitted to the laboratory or hospital information system.
Detection Method: fluorescent dye, a quantitative test for use with the CIA-1000 Immunofluorescence Quantitative Analyzer
Cut-off Value: 0.1 ng/ml
Sample Type: plasma or whole blood in Heparin, serum.
Reaction Time: yields results in about 15 minutes.
Storage Temperature:4-30°C
Storage Life: 24 months. Use the test card within 1 hour once the foil bag is opened
Package
1) For CIA-1000
A box package contains 25 tests:
Foil bag, which contains one test card and one desiccant |
25 |
Disposable pipet |
25 |
Manual |
1 |
SD card |
1 |
Whole blood buffer |
1 |
Clinical Applications:
PCT can be used to judge the severity of bacterial infection and to predict the risks of systemic inflammation and sepsis. PCT is the best indicator for bacterial infection and sepsis diagnosis. It was shown that PCT may help guide therapy and reduce antibiotic use, which can save on cost of antibiotic prescriptions and drug resistance.
hs-CRP+CRP (Immunofluorescence)
– Simple, easy to use
– Fast, results in 20 minutes
– Easy to read result
– Use whole blood, serum, plasma or fingertip blood
– Room temperature storage
Basic Informations:
hs-CRP+CRP Fast Test Kit (Immunofluorescence Assay)is intended for use together with CIA-1000 Immunofluorescence Quantitative Analyzer
to quantitatively determine the concentrations of hs-CRP+CRP in human serum, plasma, whole blood or fingertip blood specimens in Point-of Care and laboratory settings. The test uses the fluorescent conjugated anti-human hs-CRP+CRP monoclonal antibody to detect any hs-CRP+CRP appeared in blood samples. The fluorescence intensity of the test line increases proportionally to the amount of hs-CRP+CRP in a sample.
Then insert test card into CIA-1000. The concentration of hs-CRP+CRP in a sample will be determined and displayed on the screen. The value will be stored in CIA-1000 and available for downloading. The result can be easily transmitted to the laboratory or hospital information system.
Package
(1) For CIA-1000
A box package contains 25 tests:
Foil bag, which contains one test card and one desiccant |
25 |
Disposable pipet |
25 |
Manual |
1 |
SD card |
1 |
Sample diluent |
25 |
Clinical Applications:
Department |
Clinical Application
|
Respiration |
Respiratory tract infection ,pulmonary infection (bacterial),lung neoplasm,tuberculosis, pulmonary infarction, lung abscess, empyema |
Pediatrics |
Diagnosis and identification of various inflammatory or infection diseases of children and infants |
Gastroenterology |
Cholecystitis, liver abscess, peritonitis, malignant tumor |
Urology |
Pyelonephritis, endonephritis, cystitis, perinephretic
Abscess, cancer etc |
Gynecology |
Clinical detection of normal gynecological inflammation, therapy monitoring of gynecologic surgery |
Stomatology |
Periodontitis, maxillofacial infection , maxillofacial injuries, implant surgery, ICU, monitoring the nosocomial infections, detection before and after tooth extraction operation |
Oncology |
Accessory diagnosis of malignant neoplasm, detection after chemotherapy, clinical detection before or after tumor operation |
Cardiology |
Detection of cardiovascular inflammatory lesion, monitoring the prognostic implications of cardiac diseases |
Other departments |
Collagenosis, allergic and autoimmune disease activity period (rheumatism, SLE, rheumatoid), infectious disease, sepsis and other malignancies |
Fertility
HCG+β(Immunofluorescence)
– Simple, easy to us
– Fast, results in 10 minutes
– Easy to read results
– Use serum or plasma
– Room temperature storage
Basic Informations:
HCG+β Fast Test Kit (Immunofluorescence Assay) is intended for use together with CIA-1000 Immunofluorescence Quantitative Analyzer
to quantitatively determine the concentrations of human chorionic gonadotropin (HCG+β) in human serum or plasma specimens in Point-of Care and laboratory settings. The test uses the fluorescent conjugated anti-human ?-HCG+β monoclonal antibody to detect any HCG+β appeared in blood samples. The fluorescence intensity of the test line increases proportionally to the amount of HCG+β in a sample.
Then insert test card into CIA-1000. The concentration of HCG+β in a sample will be determined and displayed on the screen. The value will be stored in CIA-1000 and available for downloading. The result can be easily transmitted to the laboratory or hospital information system.
Package
1) For CIA-1000
A box package contains 25 tests:
Foil bag, which contains one test card and one desiccant |
25 |
Disposable pipet |
25 |
Manual |
1 |
SD card |
1 |
Clinical Applications:
Diagnosis of early pregnancy
Diagnose and monitor the status of the embryonic development
Diagnosis if ectopic pregnancy
Observation of threatened abortion and incomplete abortion
Assistance in the diagnosis of Down’s syndrome(DS) with AFP and FE3
Diagnosis and prognosis of trophoblastic disease, therapeutic effect.
Hormone
TSH(Immunofluorescence)
– Simple, easy to use
– Fast, results in 20 minute
– Easy to read results
– Use whole blood, serum or plasma
– Room temperature storage
Basic Informations:
TSH Fast Test Kit (Immunofluorescence) is intended for in vitro quantitative determination of thyroid-stimulating hormone (TSH) in serum, plasma or whole blood. This test is used in the screening, clinical diagnosis, prognosis and therapeutic effect evaluation of thyroid diseases.
Clinical Applications:
1.As an aid in the diagnosis of primary hyperthyroidism
2.As an aid in the diagnosis of primary hypothyroidism
3.First strategy for abnormal thyroid function diagnosis
4.Screening newborns for hypothyroidism
5.Screening of TSH levels during pregnancy
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