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'other clinical findings'

Items tagged with 'other clinical findings'

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Rapid Test

The OnSite Leptospira IgG/IgM Combo Rapid Test is a lateral flow chromatographic immunoassay that can be performed within 15-20 minutes by minimally skilled personnel, and without the use of laboratory equipment. This test is intended to be used for the simultaneous detection and differentiation of IgG and IgM antibodies to Leptospira interrogans (L. interrogans) in human serum, plasma or whole blood. It is intended to be used as a screening test by professionals, and provides a preliminary test result to aid in the diagnosis of infection with L. interrogans. Any interpretation or use of this test result must also rely on other clinical findings as well as on the professional judgment of health care providers. Recommended for use: Any person presenting with clinical signs or symptoms consistent with acute infection with interrogans including: high fever, headache, chills, muscle aches, vomiting, jaundice, red eyes, abdominal pain, diarrhea, skin rash After exposure to a known contaminated source Accuracy: 100% specificity and 100% sensitivity in comparison with a reference rapid test on the market Cross Reactivity: No false positive results were observed on specimens from TP, HIV, Dengue, TB, Typhoid Ab , HBsAg, HCV Ab, HEV Ab, H.P Ab, HAV, HCG, RF, ANA, HAMA Interference: No interference were seen with substances: Salicylic acid: 4.34 mmol/L; Glucose: 55 mmol/L; Sodium citrate: 3.8 %; Heparin: 3,000 U/L; Creatinine: 442 μmol/L; Bilirubin: 20 mg/dL; EDTA: 3.4 μmol/L; Hemoglobin: 2g/L; Human IgG: 1000 mg/dL; AlbuminL 60 g/L Shelf life: 24 month Individually sealed foil pouches containing: One cassette device One desiccant 5 μL capillary tubes Sample diluent (REF SB-R0101, 5 mL/bottle) One package insert (instruction for use) CTK Products at a Glance Inserts U.S. CDC Leptospira Homepage: About Leptospira WHO: Leptospirosis Fact Sheets

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Rapid Test

The OnSite HBV-5 Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection of hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (HBsAb), hepatitis B e-antigen (HBeAg), hepatitis B e-antibody (HBeAb), and hepatitis B core antibody (HBcAb) in human serum or plasma. It is intended to be used by healthcare professionals to aid in the diagnosis of infection with hepatitis B virus (HBV). Any use or interpretation of this preliminary test result must also rely on other clinical findings and the professional judgment of healthcare providers. Alternative test method(s) should be considered to confirm the test results obtained by this device. Panel format cassette to conveniently test for five targets at once Utilize all markers to help distinguish between acute and chronic infections Result in 15 minutes Individually sealed foil pouches containing: One cassette device One desiccant Plastic droppers Package insert (instruction for use) CTK Products at a Glance Inserts Poster U.S. CDC: hepatitis B Virus FAQs for Health Professionals WHO: Health Topic for Hepatitis

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Rapid Test

The OnSite Duo HSV-1/2 IgG/IgM Rapid Test is a lateral flow chromatographic immunoassay for qualitative detection and differentiation of antibodies (IgG and IgM) to herpes simplex virus 1 (HSV-1) and herpes simplex virus 2 (HSV-2) in human serum, plasma or whole blood. This test can be performed in 10 minutes by minimally skilled personnel without the use of laboratory equipment. This test is intended to be used by professionals as a screening test and provides a preliminary test result to aid in the diagnosis of infection with HSV-1 and/or HSV-2. The OnSite Duo HSV-1/2 IgG/IgM Rapid Test uses HSV-1 glycoprotein G1 and HSV-2 glycoprotein G2 for the specific detection and differentiation of IgG and IgM antibodies to HSV-1 and HSV-2 in serum, plasma and whole blood. An HSV-1 and/or HSV-2 IgM positive result indicates an active infection, which may be primary or recurrent. An HSV-1 and/or HSV-2 IgG positive result indicates a recent or past infection. However, a negative test result does not preclude the possibility of infection with HSV-1 and/or HSV-2. Any interpretation or use of this preliminary test result must also rely on other clinical findings as well as on the professional judgment of health care providers. Alternative test method(s) should be considered to confirm the test result obtained by this device. Clinical accuracy: 90.6% sensitivity and 91.4% specificity for anti-HSV-1 IgG detection 93.8% sensitivity and 96.0% specificity for anti-HSV-2 IgG detection 85.0% overall agreement for anti-HSV-1 IgM detection comparing to commercial ELISA 100% overall agreement for anti-HSV-2 IgM detection comparing to BBI Panel (PTH202) Positive rate on random clinical specimens:8% for IgG anti-HSV-1 and 4.9% for IgM anti-HSV-1 (n=10,000); 4.6% for anti-HSV-2 IgG and 1.7% for anti-HSV-2 IgM Cross reactivity: no cross reactivity with the following disease states or special conditions, respectively: palladium, H. pylori, Dengue, Malaria, Typhoid, Toxoplasma, Rubella, CMV, hCG, TB, HAV, HBV, HCV, HEV, HIV, ANA, HAMA, RF (up to 1,000 IU/mL) Interference: No interference was seen with Albumin 60 g/L , Hemoglobin 2 g/L, Bilirubin 20 mg/dL, Heparin 3,000 U/L, Creatinine 442 µmol/L, Salicylic acid 4.24 mmol/L, EDTA 3.4 µmol/L, Sodium citrate 8%, Glucose 55 mmol/L Shelf life: 24 months Individually sealed foil pouches containing: One cassette device One desiccant Capillary tubes (10 µL) Sample diluent (REF SB-R0203, 5 mL/bottle) Package insert (instruction for use) Individually sealed foil pouches containing: One cassette device One desiccant Capillary tubes (10 µL) Sample diluent (REF SB-R0203, 5 mL/bottle) Package insert (instruction for use)

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Clinical Chemistry

Best Fully Automated Clinical Chemistry Analyzer – Sphera M from Accurex. This chemistry analyzer is made in Italy & provides Accurate, Precise and Rapid Testing Solution. Sphera M is a Compact, fully automated, open random-access analyzer. The Minimum reaction volume is 210 µl, Minimal < 1L/h water consumption, 80 reusable UV transmitting Bionex® plastic cuvettes, 8-step wash station. It has Removable refrigerated tray with 30 open reagent positions for 50 ml or 20 ml bottles. Multiple virtual reagent disks can be programmed. The Chemistry analyser also does Auto-wash of inner & exterior probe surface. QUALITY CONTROL & CALIBRATION QUALITY CONTROL: • Levey-Jennings plots and Westgard multi rules • Upto 3 QC levels per test • QC monitor and reports • Method statistics: Test counter, CV%, mean, graphical trend analysis CALIBRATION: • Method and reagent monitor (volumes, available tests, calibration, QC status) • Automatic pre-dilution for calibrators • Upto 8 calibrators per method • Auto recalculation of result using last calibration. UNIQUE SOFTWARE DESIGN AND ARCHITECTURE: • Software designed for touch screen use • Intuitive user interface • Continuous loading of samples and reagents • Random-access and STAT • Free choice of execution order • Extended walk-away capability • Results archive with cumulative charts • Programmable automatic start up routine • Multiple work lists INTERFACE: • Bi-directional LIS, ASTM, over ethernet port of the external PC • Positive identification of samples with internal barcode reader (optional) • Printing on any Windows 7®/8® compatible printer • Method defined washing programs SYSTEM PACKS FOR SPHERA™ Accurex has developed dedicated system packs for Sphera™. Our biochemistry reagents have been intensively evaluated and validated to achieve the highest performance in Sphera™. Accurex recommends the use of these system packs according to instructions and applications validated by Accurex. Safety Information 8-step wash station for thorough cleaning of each cuvette (Needles: 6 dispensing, 6 aspiration, 1 cleaning) • Two types of systemic and special washing solutions for removing obstinate probe residues Direction for Use QUALITY CONTROL • Levey-Jennings plots and Westgard multi rules • Upto 3 QC levels per test • QC monitor and reports • Method statistics: Test counter, CV%, mean, graphical trend analysis CALIBRATION • Method and reagent monitor (volumes, available tests, calibration, QC status) • Automatic pre-dilution for calibrators • Upto 8 calibrators per method • Auto recalculation of result using last calibration Other Info Accurex has developed dedicated system packs for Sphera™. Our biochemistry reagents have been intensively evaluated and validated to achieve the highest performance in Sphera™. Accurex recommends the use of these system packs according to instructions and applications validated by Accurex.

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Clinical Chemistry

EM 360 is a Fully Automated Clinical Chemistry Analyser which is time tested and proven technology. It is designed to provide the most demanding productivity, speed and operational ease. EM 360 with a throughput of 360 tests/hour offers flexibility in operation and rugged performance to win against high workload, tight deadlines, multiple tasks and complexity of testing. It yields high quality results for virtually any biochemistry test to deliver quick, efficient and consistent performance. Product Features: Automated, Discrete, Patient prioritized, Floor model Based on proven technology, Diffraction Grating Separate probes for Reagent R1 & R2 and dedicated probe for sample Low reading volume of 200 µl only Onboard cooling for reagents to enhance the reagent stability Barcode for reagents & samples (Optional) Wide test menu Product Applications: End Point Reactions: Glucose, Cholesterol, Triglycerides, Albumin, Total Protein, Uric Acid, Calcium, Magnesium, Bilirubin Total, Bilirubin Direct Kinetic Reactions: SGOT, SGPT, GGT, LDH, CK, CK MB, ALP, ACP, Amylase, Lipase Two Point Rate Reactions: Urea, Creatinine Immunoturbidimetric Chemistries: RA, CRP, ASO, Direct HDL, Direct LDL, Apo A, ApoB, Lp (a) Special Chemistries: HbA1c, Iron, Ferritin, Phosphorus, Microprotein, Ammonia, Bicarbonates System Type: Discrete, automated, random access, patient prioritized clinical chemistry analyzer Throughput: 360 tests / hour photometric and 600 tests / hour with ISE* (*optional ISE with Na+, K+, Cl-, Li+) Analytical Methods: 1-Point, 2-Point, Rate-A, Rate-B, Direct Potentiometry (optional) Barcode Reader: For reagents and samples (optional) Reaction Tray: 60 hard glass cuvettes Reaction Mixing: Stirrer with variable speed Minimum reaction Volume: 150 μl with maximum 200 μl reading volume On-board Laundry: 5 stage cleaning, 2 stage drying Photometer: Multi-wavelength diffraction grating with 12 wavelengths (340, 376, 415, 450, 480, 505, 546, 570, 600, 660, 700, 750 nm) OD Range: 0.0 - 3.0 Light Source: Halogen lamp Detector: Silicon photo-diode Water Consumption: < 10 litres Programmable Parameters: Default system pack parameters + upto 99 user defined parameters, Unlimited profile and unlimited calculation items Quality Control: QC plot data with QC rules. Provision for lab mean. Twin plot Calibration: K-Factor, Linear (1, 2 point & multipoint), 4P and 5P Logit-log, cubic spline, exponential, polynomial, On-board serial dilution for calibrator Power Requirement: AC 220 V ± 10 %, 50 Hz or AC 110 V ± 10 %, 60 Hz Power Consumption: 800 VA Dimension (mm): Approx. 675 (W) x 840 (D) x 1120 (H) Weight: Approx. 150 kgs. SAMPLE HANDLING Sample: Serum, Plasma, Urine, CSF, Whole blood, other Sample Unit: 82 positions for samples, blank , controls, calibrators, STAT sample Sample Pipetting: 2 - 70 µl (adjustable in 0.1 µl step) for Biochemistry, 70 µl fixed for ISE Capacitance probe with liquid level sensing & vertical obstruction detection, serum indices Auto Rerun: Repeat with same, increased or decreased volume ( upto 1:150) Sample Tubes /Cups: Primary tubes of 5 ml, 7 ml, 10 ml and sample cups REAGENT HANDLING Reagent Tray: 50 positions for reagents with onboard cooling Reagent Pipetting: R1: 50 - 300 µl (adjustable in 1 µl step) R2: 10 - 200 µl (adjustable in 1 µl step) Capacitance probe with level sensing & vertical obstruction detection SYSTEM INTERFACE: Analyzer-PC: USB PC - Host Computer: Bidirectional TCP / IP & RS - 232 PC - Printer: USB Operating System: Windows Based Database: Unlimited Results

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Clinical Chemistry

Product Description: XL-640 with CRS is a random access, discrete, patient prioritized, fully automated clinical chemistry analyzer with autoloader designed to meet the needs of today’s modern clinical laboratories with high workload. Once samples are loaded, it is a complete walk-away system. XL 640 CRS is designed to operate smoothly over the long haul and to deliver consistent quality report. Product Features: Throughput of 400 tests/ hour (Photometric) and 640 tests/hour with ISE 56 Reagent Positions with On-board cooling for reagents 162 Sample positions with /Autoloader Separate probes for reagent R1 & R2 and dedicated probe for sample Clot detection for sample probe, Reflex testing and Serum Indices identification 72 permanent hard glass cuvettes with On-board Laundry Automatic dilution for high abnormal samples & Auto Rerun facility Extensive QC Programmes with Levy –Jennings Curve & QC rules. Automatic calculation for Mean SD & CV% Direct loading for primary tubes Touch screen User Friendly GUI with Bi-directional connectivity. System General System Type: Automated, Discrete, Random Access, Patient Prioritized Clinical Chemistry Analyzer with Autoloader Throughput: 400 photometric tests/hour & 640 tests/hour with ISE (*optional ISE with Na, K, Cl, Li) Analytical Methods: 1-Point, 2-Point, Rate-A, Rate-B, Direct Potentiometry(optional) Barcode Reader: Both for Samples & Reagents (Optional) Reactions Tray: 72 hard glass cuvettes Reaction Mixing: Dual Stirrer with variable speed Reading Volume: 180 µl On-Board Laundry: 6 stage cleaning, 2 stage drying Photometer: Multi-wavelength diffraction grating with 12 wavelengths (340, 376, 415, 450, 480, 505, 546, 570, 600, 660, 700 & 750 nm) O.D. Range: 0 - 3.0 Light Source: Halogen Lamp Detector: Silicon Photodiodes Water Consumption: < 14 liters/hour Programmable Parameters: Default system pack parameters + upto 99 user defined parameters, Unlimited profiles and unlimited calculation items Quality Control: Q.C. plot data with Q.C. Rules. Provision for lab mean. Twin plot. Caliberation: K- factor, Linear (1,2 point and multipoint) 4P and 5P Logit-log, Cubic spline,exponential, polynomial. On-board serial dilution for calibrator Power Requirement: AC 220 V ± 10 %, 50 Hz or AC 110 V ± 10 %, 60 Hz Power Consumption: 800 VA Dimensions: Approximately 897 mm (w) x 655 mm (D) x 1170 mm (H) Weight: Approximately 200 Kg Sample Handling Sample: Serum, Plasma, Urine, CSF, Whole blood, other Sample Unit: upto 162 positions for samples/STAT/calibrator/controls with Autoloader Sample Pipetting: 2-70 µl (adjustable in 0.1 µl steps) for biochemistry,70 µl fixed for ISE capacitance probe with liquid level sensing and vertical obstruction detection , clot detection and serum indices and Reflex Testing Auto Rerun: Repeat with same, increade and decresaed volume (upto 1:150) Sample Tubes/Cups: Primary tubes of 5 ml, 7ml and 10 ml and sample cups Reagent Handling Reagent Tray: 56 positions for reagents with on-board cooling Reagent Pipetting: R1: 60 - 300 µl (Adjustable in 1 µl step) R2: 0 or 10 - 300 l (Adjustable in 1 µl step) Capacitance probe with level sensing and vertical obstruction detection System Interface Analyzer-PC: USB PC- HOST Computer: Bidirectional TCP/IP and RS - 232 PC- Printer: USB Operating System: Windows based with Touch Screen User Friendly GUI Database: Unlimited Results

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Biochemistry Analyzer

Yumizen CA40 Semi-automated Clinical Chemistry Analyzer: Yumizen CA40 is a semi-automated Clinical Chemistry analyzer with facility to perform Chemistry, Immunoturbidimetry and Coagulation Tests (PT & APTT). It is an ideal solution for small laboratories with the facility to perform a wide range of biochemical tests. Specification:- Semi-automated Clinical Chemistry analyzer with coagulation tests capacity (PT & APTT) 8 incubation positions for chemistry tests and 5 positions for coagulation tests 8-inch colored touch screen display Tri-level Quality Control with Levey-Jennings chart 6 filters with additional 2 open positions Show less

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immunoassayReagents

INTENDED USE The Finecare™ Vitamin D Rapid Quantitative Test along with Finecare™ FIA Meter is a fluorescence immunoassay quantitative determination of total 25(OH) D2/D3 level in human serum or plasma. Results are to be used in conjunction with other clinical and laboratory data to assist the clinician in the assessment of vitamin D sufficiency. STORAGE AND STABILITY 1. Store at 4°C~30°C up to the expiration date. 2. The solid marker bottle can be stored at 2°C~8°C for 28 days after being reconstituted. 3. Do not remove the device from the pouch until ready to use. The Test Cartridges should be used within 1 hour once opened.

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Immunoassay Reagents

INTENDED USE The Finecare™ 2019-nCoV lgM/lgG Test is a fluorescence immunoassay used along with Finecare™ FIA Meters for qualitative detection of IgG and IgM antibodies of novel coronaviruses (2019-nCoV) in human whole blood, serum and plasma specimen. Clinically, the test is to be used as an aid in the diagnosis of coronavirus infection disease (COVID-19), which is caused by 2019-nCoV. The test provides preliminary test results. Negative results cannot exclude the possibility of 2019-nCoV infection and they cannot be used as the sole basis for treatment or other management decision. STORAGE AND STABILITY 1. Store at 4-30°C in the sealed pouch up to the expiration date printed on the package. Do not freeze. 2. The test device should be used within 1 hour after taking out from the foil envelope. 3. Keep away from sunlight, moisture and heat. 4. Kit contents are stable until the expiration date printed on the outer box.

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