Product Preview i-CHROMA Boditech.pdf

April 5, 2018 | Author: Anonymous | Category: Documents
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Overview One of the noticeable trends in diagnostic market is the rapid shift of technology from the conventional instruments used in major hospitals or clinical laboratories to the point of care tests (POCT), where tests are performed in doctor’s offices, patients’ bedside and even at homes. We are on the forefront in this technology and have developed an integrated POCT system in line with this trend in diagnostics. Our i-CHROMA is a POCT diagnostic system optimized for the screening of major "life- style related" diseases including, but not limited to, cardiac diseases, diabetes and cancers. i-CHROMA system delivers the result in 3~15 minutes after taking the blood sample from the patient's fingertip right at the doctor's office. It is one-of-a-kind multi-parameter POCT system in the world. We have adopted ISO 13485 system to ensure continued quality assurance for our diagnostic systems and test devices. As we strive toward higher quality and reliability, we have been approved by USFDA and certified for CE. We are pioneering a new paradigm of POCT in the diagnostic world and your interests and encouragement would be healthy stimulus for us to grow upon. Visit Us : www.umaraleksana.co.id “ We are represented in over 40 countries worldwide.” We constantly expand out network through major tradeshows and strengthen ties with existing customers through long-term commitments. I CHROMA Reader TM i-CHROMADUO HEMOCRHOMATM Mini FLOUROMETER Visit Us : www.umaraleksana.co.id Reader General Information The i-CHROMATM reader is a portable instrument dedicated to scan, detect and process the signal from the diagnostic testing devices provided by Boditech Med Inc. Once the testing device cartridge is loaded into this reader after the preprocessing procedure, the cartridge is sent to a designated location where it is irradiated with a beam of laser with 647nm wavelength. The fluorescence signal generated by fluorophores labeled onto capture molecules are optically collected and converted into clinically meaningful quantities by proprietary firmware stored in the onboard processor automatically. This result is displayed TM on the face plate of the reader. The i-CHROMA reader can forward this information to a receipt printer, to an external PC or even to the LIS via optional accessories. The i-CHROMATM reader is equipped with a set of self-diagnostic routines that continuously monitor the system integrity. The built-in interlocking errorprevention system consists of a coded ID Chip provided with the test device and the barcode on each test device. Any discrepancy among them would produce a warning message and prevents further operation until the problem is resolved. TM The firmware on i-CHROMA reader can be upgraded easily by the user. The user can use the proprietary firmware upgrade kit from Boditech Med or download the binary file from Boditech homepage and execute the upgrade process. Key Features of i-CHROMATM reader Quantitative results Closed system One-dimensional scanner geometry High throughput: up to 45 samples per hour Simple user interface Supports up to 50 parameters (customizable) Automatically identifies sample types (Whole blood or Serum/Plasma): no user input necessary Simplified firmware upgrade Supports remote technical service Flexible communications via a RS232C port (printer, PC, LIS). Optional scanner and keypad connection interface available Enhanced mobility: can be retrofitted for battery operation in a travel package Comparable performance with high end reference analyzers Power requirement:100~240VAC 50~60Hz, 12V battery pack available. Weight 1.2 kg, Dimension 185x80x 250 mm (WHL) Principle Laser energy irradiating the scan line on the test device induces the emission of characteristic fluorescence off the fluorophores immobilized on the detection biomaterials, which were captured by capture molecules previously immobilized on the test device. The amount of this fluorescent energy is closely correlated with the relative amount of the TM analyte under measurement. i-CHROMA reader is equipped with the confocal optical arrangement widely adopted and proven in most confocal fluorescence microscopes. This guarantees the best possible background rejection, which is of crucial importance when one wants to increase the detection sensitivity. The firmware takes care of the whole operation after accepting the test device into the carriage. The user inputs via keys located on the faceplate or via external commands from externally connected control computer. Visit Us : www.umaraleksana.co.id Cardiac Markers Connectivity The i-CHROMATM reader can be networked indirectly through its communication port (RS232c). One may use off-the-shelf serial receipt printers for immediate printout. An external computer will be handy in controlling and managing the accumulated data from the reader and in establishing and maintaining the connection to other networks, most likely a LIS server. An interface module is also available that enables the entry of the patient ID via a keyboard and/or a hand-held barcode scanner. Visit Us : www.umaraleksana.co.id Cardiac Markers General Information Cardiac troponins are currently the most sensitive and specific biochemical markers of myocardial necrosis. There are three troponin proteins in heart muscle fibers,Troponin C, I, and T. Together they cooperate to make muscle fibres contract. The clinical measurement of serum cardiac troponin I(Tn-I) has become an important tool in the diagnosis of acute myocardial infarction. Cardiac troponin I has been observed in people with renal failure, sepsis, stroke and other conditions. The average concentration of Tn- I in healthy adults is below 1ng/ml but it shows a great increase in patients with damaged heart muscle as in acute coronary syndrome, cardiomyopathy, and myocardial infarction for example. Serum troponin I is a more powerful prognostic marker in people with ischemic chest pain than CK-MB and shows significant increases in serum. National and international scientific organizations have suggested the use of these markers when implementing new diagnostic strategies in patients with acute coronary syndrome. Since Tn I is well known to be an important prognostic indicator of heart diseases, its most definitive role is in monitoring post-treatment clinical status and the post therapeutic evaluation of patients. Key Features of i-CHROMATM Tn-I Test Quantitative Test Result Sample Type : Serum, Plasma. Sample volume : 75 ìl Detection Limit : 0.01 ng/ml Working range : 0.01 ~ 50 ng/ml Cut Off : 0.6 ng/ml Precision : CV % 2~15 in working range Log Shelf Life : 20 months Fast Test Result : 12 minutes Comparable Test Result with Full Automatic AnalyzerNo Calibration Needed Principle The i-CHROMATM Tn-I Test is based on fluorescence immunoassay technology. The i-CHROMATM Tn-I Test uses a sandwich immunodetection method, such that the fluorescence-labeled detector antibody or antigen binds to the target protein in serum or plasma specimen. Signal intensity of fluorescence reflects amount of the Tn-I captured and is microprocessed from i-CHROMATM Reader to show the Tn-I concentration in the specimen. Test Procedure Visit Us : www.umaraleksana.co.id Cardiac Markers General Information TM i-CHROMA hsCRP test kit is used to measure total CRP concentration in human serum, plasma or whole blood along with i-CHROMATM reader. The test kit consists of a test strip in a disposable plastic cartridge and detector buffer. The components of test strip are antibody-immobilized nitrocellulose membrane, a sample pad, an absorption pad, and a backing card. After the sample and detector are mixed well, the sample mixture is loaded onto a test TM device and waited 3 minutes for immune reaction. The device is then inserted into the holder of i-CHROMA reader for quantification of CRP TM concentration in blood. The i-CHROMA reader is a small fluorescence instrument for quantification of analyte concentration of immunoassays manufactured by Boditech Med Inc. The assays and instrument are for in vitro diagnostic use only. The i-CHROMATM reader can be used in point-of-care TM testing settings and central laboratories. The i-CHROMA reader uses a laser as the excitation light source. The emitted light from the fluorescence dye is detected and converted into an electrical signal. The signal is directly proportional to the amount of fluorescence present. The concentration of an analyte is calculated based on pre-programmed calibration. The specificity of each test is programmed into the test cartridges accepted by i-CHROMATM reader. Key Features of i-CHROMATM HsCRP Test Quantitative Test Result Sample Type: Whole blood, Serum, and Plasma Sample volume: 10 ìl Detection Limit: 0.1 mg/L Working range: 0.1~10 mg/L Cut Off: < 1 mg/L Precision: CV% 2-10 in working range Long Shelf Life: 20 months Fast Test Result: 3 minutes User Friendliness: No Pipette Used Comparable Test Result with Full Automatic Analyzer No Calibration Needed Principle TM The i-CHROMATM hsCRP Test is based on fluorescence immunoassay technology. The i-CHROMA hsCRP Test uses a sandwich immunodetection method, such that the fluorescence-labeled detector antibody or antigen binds to the target protein in blood specimen. Signal intensity of TM fluorescence reflects amount of the CRP captured and is microprocessed from i-CHROMA Reader to show the CRP concentration in blood specimen. Test Procedure Visit Us : www.umaraleksana.co.id Cardiac Markers General Information D-dimer, a degradation product of cross-linked fibrin formed during activation of the coagulation system, is commonly used to exclude thromboembolic disease in outpatients suspected of having deep venous thrombosis (DVT) and pulmonary-embolism(PE). By providing a quick, noninvasive alternative to costly imaging, D-dimer has demonstrated to aid in the exclusion of venous thromboembolism(VTE) in outpatients. Deep vein thrombosis(DVT) and Pulmonary Embolism(PE) are relatively common and can cause sudden, fatal embolic events in the pulmonary arteries and other regions. Although prompt detection and treatment of DVT are necessary, DVT is usually subclinical and often underdiagnosed. Measurement of plasma D-dimer level has been used as a screening strategy for subclinical DVT. A systematic review reported that a normal range of a highly sensitive D-dimer level accurately ruled out DVT in patients classified as having a low or moderate clinical probability of DVT. Stroke is a highrisk factor for DVT because of advanced age, hemiplegia, and coagulation disorders; DVT can cause paradoxical embolic stroke via a right-to left shunt. Thus, it is important to understand the incidence and characteristics of DVT in acute stroke patients. Plasma D-dimer level has proven to be useful for DVT screening in chronic stroke patients undergoing rehabilitation. National and international scientific organizations have suggested the use of these markers when implementing new diagnostic strategies in patients with coronary syndrome. Since D-Dimer is well known to be an important prognostic indicator of heart diseases, its most definitive role is in monitoring post-treatment clinical status and the post therapeutic evaluation of patients. Key Features of i-CHROMATM D-Dimer Test Quantitative Test Result Sample Type: Plasma Sample volume: 75 ìl Detection Limit: 50 ng/ml Working range: 50 ~ 10,000 ng/ml Cut Off: 300 ng/ml (DDU:D-Dimner Unit) Precision: CV% 2-10 in working range Long Shelf Life: 20 months Fast Test Result: 5 minutes Comparable Test Result with Full Automatic Analyzer No Calibration Needed Principle TM The i-CHROMA D-Dimer Test is based on fluorescence immunoassay technology. The i-CHROMATM D-Dimer Test uses a sandwich immunodetection method, such that the fluorescence-labeled detector antibody or antigen binds to the target protein in serum or plasma specimen. Signal intensity of fluorescence reflects amount of the D-Dimer captured and is microprocessed from i-CHROMATM Reader to show the D-Dimer concentration in serum or plasma specimen. Test Procedure Visit Us : www.umaraleksana.co.id Cancer Markers General Information Prostate specific antigen (PSA) is a neutral serine protease with chymotrypsin-like activity. It is composed of a single polypeptide chain of 237 amino acids. It is an intracellular glycoprotein containing 7-8% carbohydrate as a single N-linked oligosaccharide side chain, and has a molecular weight of approximately 33 KDa. PSA is synthesized by the glandular epithelium of the prostate and present in benign hyperplastic and malignant prostatic tissue, in metastatic prostatic carcinoma, in prostatic fluid, and seminal plasma. Low levels of PSA are found in the blood of normal male as a result of leakage of antigen from the prostate gland into circulation. The elevated levels of PSA in the blood are associated with prostatic pathology, including prostatitis, benign prostatic hyperplasia(BPH), and prostate cancer. The i-CHROMATM PSA Test measures quantitative PSA concentration in human serum, plasma, or whole blood. Key Features of i-CHROMATM PSA Test Quantitative Test Result Sample Type : Whole blood, Serum, and Plasma. Sample volume :Whole blood - 30 ìl, Serum, Plasma - 75 ìl Detection Limit : Whole blood - 0.5 ng/ml, Serum, Plasma - 0.1 ng/ml Working range : Whole blood - 0.5 ng/ml ~ 100 ng/ml Serum, Plasma - 0.1 ng/ml ~ 100 ng/ml Cut Off : 4ng/ml Precision : CV% 2-10 in working range. Long Shelf Life : 20 months Fast Test Result : 15 minutes User Friendliness : Pipette Used Comparable Test Result with Full Automatic Analyzer No Calibration Needed Principle The i-CHROMATM PSA Test is based on fluorescence immunoassay technology. The i-CHROMATM PSA Test uses a sandwich immunodetection method, such that the fluorescence-labeled detector antibody or antigen binds to the target protein in blood specimen. Signal intensity of fluorescence TM reflects amount of the PSA captured and is microprocessed from i-CHROMA Reader to show the PSA concentration in blood specimen. Test Procedure Visit Us : www.umaraleksana.co.id Cancer Markers General Information Alpha-fetoprotein (AFP) is a member of a1-globulin family of human plasma proteins and a glycoprotein with a molecular weight approximately 70 kDa. AFP is produced primarily in the liver of developing fetus; therefore can be found in maternal blood and in amniotic fluid. The concentration of AFP in healthy adult is below 20 ng/ml but it shows a great increase in several malignant diseases, mostly primary hepatocelluar carcinoma and nonseminomatous testicular cancer. Some 70-90% of patients with primary hepatocelluar carcinoma and non-seminomatous testicular cancer have been observed to have high levels of serum AFP. High levels of serum AFP also have been found in a limited number of patients diagnosed with various diseases such as gastrointestinal tract cancer, viral hepatitis, chronic active hepatitis, alcoholic cirrhosis, and adenocarcinomas of lung, pancreas, and gall bladder. Since AFP is well known to be an important prognostic indicator of non-seminomatous testicular cancer, its most definitive role is in monitoring post-treatment clinical status and the post therapeutic evaluation of patients. Key Features of i-CHROMATM AFP Test Quantitative Test Result Sample Type: Whole blood, Serum, and Plasma. Sample volume:Whole blood - 30 ìl, Serum, Plasma - 15 ìl Detection Limit: 5ng/ml Working range: 5 ng/ml ~ 350 ng/ml Cut Off: 20ng/ml Precision: CV% 2-10 in working range. Long Shelf Life: 20 months Fast Test Result: 15 minutes User Friendliness: Pipette Used Comparable Test Result with Full Automatic Analyzer No Calibration Needed Principle TM The i-CHROMATM AFP Test is based on fluorescence immunoassay technology. The i-CHROMA AFP Test uses a sandwich immunodetection method, such that the fluorescence-labeled detector antibody or antigen binds to the target protein in blood specimen. Signal intensity of fluorescence reflects amount of the AFP captured and is microprocessed from i-CHROMATM Reader to show the AFP concentration in blood specimen. Test Procedure Visit Us : www.umaraleksana.co.id Cancer Markers General Information CEA is an oncofetal glycoprotein, which is found at high levels in the fetal colon and at lower levels in the normal adult colonic epithelium. CEA occurs at abnormally high levels in several benign disorders and in some malignant tumors, including those of the stomach, small intestine, colon, rectum, pancreas, liver, breast, ovary, cervix and lung. CEA is a 180-kD glycoprotein that occurs at high levels in colon epithelial cells during embryonic development. Levels of CEA are significantly lower in colon tissue of adults, but can become elevated when inflammation or development of tumor occurs in any endodermal tissue, including in the gastrointestinal tract, respiratory tract, pancreas and breast. CEA is also expressed by epithelial cells in several non-malignant disorders, including diverticulitis, pancreatitis, inflammatory bowel disease, cirrhosis, hepatitis, bronchitis and renal failure and also in individuals who smoke. This fact has made it difficult to use serum CEA determination as a sensitive method for cancer screening. However, serum CEA levels have been useful in monitoring individuals for the recurrence of cancer. Key Features of i-CHROMATM CEA Test Quantitative Test Result Sample Type: Serum / Plasma. Sample volume:150 ìl Detection Limit: 3ng/ml Working range: 3 ng/ml ~ 500 ng/ml Cut off : 4 ng/ml Precision: CV(%)


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