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'1000 test results'

Items tagged with '1000 test results'

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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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Instruments

The new and improved RTR-1 uses an image processing method. During measurement, the lateral flow device is captured using a 5-mega pixel camera and the picture is analyzed using image processing algorithms for identification of either presence or absence of test line bands or test line band intensity levels. The reader converts the image into a grayscale and then classifies the intensity levels of the image in 0 to 255 grayscale range. The image processing algorithm undergoes various levels of filtering and segmentation to yield the correct intensity levels from the picture. Based on the preconfigured intensity levels, the reader classifies the band intensity and reads out the results as either positive or negative. ACCURACY: Less than 3% intra-run CV Eliminates subjective interpretation by operator FLEXIBILITY: Single mode for low volume test setting Batch mode allows for high volume test setting Result output as semi-quantitative line intensity and visual image EASE-OF-USE: Built in barcode reader provides faster test setup Touch screen interface for easy operation Lightweight (0.7kg) and portable DATA MANAGEMENT: Results presented on screen, on a printout or uploaded to reader database Storage capacity of 1,000 test results (including images) Laboratory Information System (LIS) and Wi-Fi compatible Human Machine Interface 4-inch resistive touch screen Camera 5 mega pixel CMOS camera Barcode Scanner Integrated 1 dimensional barcode scanner Printer 48 mm inbuilt thermal printer Mode Single mode and batch mode operations Port/USB Data export and software upgrade through 2 USB ports Storage Storage capacity of 1000 test results (including images) Result output “Positive or Negative” as well as quantitative test line intensity Power 12V 2A Processor ARM Cortex-A53 Platform Embedded Linux Dimension 220 mm X 170 mm X 110 mm (L x B x H) Weight 0.7 kg (Approx CATALOG # PRODUCT RTR-1 Rapid Test Reader OTHER PRODUCTS YOU MIGHT BE INTERESTED IN.. CATALOG # PRODUCT ADX-110 ELISA Reader ADX-120 Microplate Washer

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Clinical Chemistry

XL 1000 with the throughput of upto 1040 tests per hour is the ideal instrument for centralizing the complete biochemistry testing load on a single fully automated platform. Increased walk away productivity and less human intervention make it an ideal analyzer for large laboratories. Equipped with all necessary advanced features that one expects from a high end fully automated chemistry analyzer; sample loading through rack system, cooled calibrator and control carousel, low reading volume of 150 µL, diffraction grating with 15 wavelengths from 340 nm to 800 nm and user-friendly software, to optimize and reliably run the daily lab workload. XL 1000 is a "dream come true" workhorse for laboratories with increased workload and the perfect solution. Fully Automatic, Discrete, Patient prioritized, Random Access Clinical Chemistry Analyzer with throughput of 1040 tests/hour 3 Reagent capabilities 147 long life Hard Glass cuvettes Separate Carousel for STAT samples Onboard refrigeration for reagents Extensive database for storing patient data and Q.C. results Primary tube sampling with bar code identification 9 stage laundry for cuvettes wash 150 samples can be loaded at a time through rack system System Discrete, open, automated, random access, patient prioritized, 1/2/3 reagent system DISPENSING OF SAMPLES AND REAGENTS Sample volume: 2-60 µl (0.1 µl step), 70 µl with ISE Reagent volume: 120 µl – 550 µl 3 dispensing probes ( R1, R2/R3) equipped with liquid -level sensor and crash detector Auto-dilution of samples and calibrators Clot detection Samples Serum, urine, plasma, CSF and other Economy Minimum reaction volume: 180 µl Reusable reaction cuvettes Mixing System 2 independent stirrers 3 user selectable mixing speeds Quality Control 4 levels of control material can be used Levey-Jennigs graphs Twin Plot diagrams for monitoring of systematic and random error Reaction unit with wash station 147 reusable hard glass cuvettes Possibility of replacement of individual cuvette Wash station – cuvette rinsing and drying in nine-step procedure Automatic cuvette blank measurement before analysis Sample Autoloader 23 racks 115 sample positions on automatic autoloader Primary tubes 5, 7 and 10 ml, vacuum system tubes Barcode reader for sample identification 2 Reagent trays With 43 cooled position each Barcode reader for reagent identification 20 ml, 50 ml reagent containers, 5 ml tube with adaptor Option to use one reagent for several test simultaneously Stat Tray 45 positions Can be used for blank, controls, STAT samples Software Convenient user interface Connection to LIS Programmable auto-start from sleep mode including automatic daily maintenance Statistical methods of processing results Data export in selected format Measurement Monitoring Colour indication of sample analysis Possibility of monitoring the reaction in real time Reagent volume monitoring Informative reports on ongoing analyzer status

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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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Rapid Test

The OnSite HSV-2 IgG/IgM Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection and differentiation of antibodies (IgG and IgM) to herpes simplex virus 2 (HSV-2) in human serum, plasma or whole blood. Unique test that utilizes glycoprotein G2 to differentiate between HSV-1. and HSV-2 that allows for an early start of treatment action. Immediate determination of either acute or chronic infection by detecting and differentiating IgG and IgM anti-HSV-2. High confidence as test is in agreement with market leading European ELISA: 95.3% IgG; 100% IgM. Flexible specimen types including serum, plasma, or whole blood which allows testing at any time without special specimen preparation. Small sample volume (10 µL) enables multiple testing on the same specimen without having to re-draw the patient. Initial treatment action can begin during patient’s visit as test results are available in 10 minutes. Easily transported, and can be stored for 24 months, 2-30oC. Individually sealed foil pouches containing: One cassette device One desiccant Capillary tubes (10 µL) Sample diluent (REF SB-R0213, 5 mL/bottle) Package insert (instruction for use) CTK Products at a Glance HSV-1 & HSV-2 Flyer Insert U.S. CDC HSV Homepage: Genital Herpes Fact Sheets WHO: Herpes Simplex Virus Fact Sheets

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Rapid Test

The OnSite HSV-1 IgG/IgM Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection and differentiation of antibodies (IgG and IgM) to herpes simplex virus 1 (HSV-1) in human serum, plasma or whole blood. Type-specific detection by utilizing glycoprotein G1. Single test that detects and differentiates IgG and IgM anti-HSV-1. High confidence as test is in agreement with market leading ELISA test: 90.7% IgG; 85.0% IgM. Flexible specimen types including serum, plasma, or whole blood which allows testing at any time without special specimen preparation. Small sample volume (10 µL) enables multiple testing on the same specimen without having to re-draw the patient. Initial treatment action can begin during the patient’s visit as test results are available in 10 minutes. Easily transported, and can be stored for 24 months, 2-30oC. 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) CTK Products at a Glance HSV-1 & HSV-2 Flyer Insert U.S. CDC HSV Homepage: Genital Herpes Fact Sheets WHO: Herpes Simplex Virus Fact Sheets

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Rapid Test

The OnSite Chikungunya IgM Combo Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection of IgM anti-chikungunya (CHIK) virus in human serum, plasma or whole blood. Uses serum, plasma or whole blood specimen Utilizes recombinant antigen derived from the CHIK structure protein IgM immunoassay is the most practical lab method Distinguish from dengue infection which presents with similar symptoms Clinical performance: Sensitivity: 90.4% Specificity: 98.0% comparing to a commercial ELISA Cross-Reactivity: no cross-reactivity found on 10-40 specimens from the 14 disease states and special conditions, such as dengue, Zika, malaria, HIV, TB, HAV, pregnant woman and others No interference with some common substances, such as Acetominophen (20 mg/dL), Heparin (3000 U/L), Ascorbic acid (20 mg/dL), Human IgG (1000 mg/dL), Bilirubin (20 mg/dL), Glucose (55 mmol/L), Creatinine (442 μmol/L), Salicylic acid (4.34 mmol/L), EDTA (3.4 μmol/L), Sodium citrate (3.8%) Individually sealed foil pouches containing: One cassette device One desiccant Capillary tubes (5 μL) Sample diluent (REF SB-R0066, 5 mL/bottle) One package insert (instruction for use) CTK Products at a Glance Inserts U.S. CDC Chikungunya Virus Homepage: (Transmission, Prevention, etc.) WHO: Chikungunya Virus Fact Sheets

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Rapid Test

The OnSite hCG Combo Rapid Test is a lateral flow chromatographic immunoassay for the early detection of pregnancy, by providing a quick direct visual test for the placental hormone, hCG in human serum, plasma and urine. It can be performed within 5-10 minutes by minimally skilled personnel, and without the use of laboratory equipment. The OnSite hCG Combo Rapid Test is not intended for quantitative results, nor for over the counter (OTC) sales. It is intended to meet all requirements for yielding rapid, easily read, qualitative results for the purpose of early pregnancy detection via assay of hCG, a placental hormone that may be present in human serum, plasma or urine. The hCG detection limit the OnSite hCG Combo Rapid Test is 12.5 mIU/mL in serum or plasma specimen, and 25 mIU/mL in urine specimen. It is designed for professional use only, and provides only preliminary analytical data. For a final diagnosis of pregnancy, a more specific alternative clinical method must be used to obtain a confirmed analytical result. Clinical accuracy: In comparison with a reference chemiluminecsence or ELISA, hCG detection is 100% sensitivity and 100% specificity in urine specimens 100% sensitivity and 99.5% specificity in serum specimens Analytical sensitivity: 100% positive detection rate at 12.5 mIU/mL in serum/plasma specimens and 100% positive detection rate at 25 mIU/mL in urine specimens Analytical specificity: no cross reactivity with 1,000 mIU/mL human luteinizing hormone (hLH), 1,000 mIU/mL human follicle stimulating hormone (hFSH), and 1,000 mIU/mL human thyroid stimulating hormone (hTSH) Dose hook effect: no dose hook effect was observed for hCG at concentrations up to 500,000 mIU/mL in urine specimens Interference: No interference was seen with 35 biological and chemical analytes commonly found in OTC, prescriptions or abuse drugs in urine or serum/plasma specimens, as well as pH 4-9 (see detail in the package insert) Shelf life: 24 month Kit box package: 1. Individually sealed foil pouches containing; a. One dip strip device b. One desiccant 2. One package insert (instruction for use) Tube package: 1. Strip Package 2. One desiccant 3. One package insert (instruction for use) CTK Products at a Glance Drugs.com: Overview of Human Chorionic Gonadotropin Inserts

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