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COVID-19 IgG/IgM Rapid Test CE

  Features:
  • The OnSite COVID-19 IgG/IgM Rapid Test is designed to detect anti-SARS-CoV-2 IgG and IgM antibodies in either human serum, plasma or whole blood within 15 minutes.
  • This test is easy-to-use, with basic equipment needs.
  • The OnSite COVID-19 IgG/IgM Rapid Test has 97.1% sensitivity and 97.8% specificity, making it one of the most effective tests for detecting previous exposure to anti-SARS-CoV-2 virus.
  • Finger prick specimen allows testing at point-of-care, saving crucial time.
  • Complementary to PCR by detecting immune response
  • Compatible with CTK Rapid Test Reader (RTR-1)
    • 200 tests per hour in batch mode
    • Capable of connecting to Laboratory Information System (LIS)
    • Built-in barcode reader provides faster test setup
    • Stores up to 1,000 results, presented on screen, via printout, or uploaded to database
    • Reagents and Materials provided:
      1. Individually sealed foil pouches containing:
        1. One cassette device
        2. One desiccant
      2. Disposable capillary tubes, marked for 10 µL and 20 µL
      3. Detection buffer (tris-based buffered solution with preservatives)
      4. Instructions for Use
      Materials Required but not provided:
      1. Clock, watch or other timing device
      2. Pipettor capable of delivering 10-20 μL of sample, that can be used instead of the disposable capillary tube for greater accuracy
      3. Sterile lancets, sterile gauze and wipes for fingerstick whole blood specimens
      4. Collection devices for venous whole blood, serum, plasma
      5. Disposable gloves, biohazard disposal container
CATALOG # PRODUCT QUANTITY SPECIMEN

R0180C

COVID-19 IgG/IgM Rapid Test CE

30/kit

S, P &WB

T4 FIA Test

Features:
  • Quantitative, non-subjective results
  • Increased sensitivity and broader detection range compared to rapid tests
  1. Range
Working range: 10.0-320.0 nmol/L
  1. Precision
Intra-lot Precision Intra-lot precision was determined by testing of T4 reference materials using 10 test devices from the same lot. CV ≤ 15%. Inter-lot Precision Inter-lot precision was determined by testing of T4 reference materials using 30 test devices from 3 consecutive lots randomly (10 test devices from each lot). CV ≤ 20%.
  1. Accuracy
T4 control materials with two different concentrations were tested by every lot of test device, and the deviations were within ± 15%.
  1. Linearity
A serial concentration of T4 reference materials at 20.0-320.0 nmol/L was tested, and the correlation coefficient (R) is ≥ 0.9900.
  1. Specificity
The concentration of T4 is not greater than 15 nmol/L when the concentration of T3 is 500.0 ng/mL. The concentration of T4 is not greater than 15 nmol/L when the concentration of rT3 is 50.0 ng/mL. Product Specifications Reagents and Materials provided:
  1. Individually sealed foil pouches containing:
    1. One test device
    2. One desiccant
  2. Detection buffer tubes
  3. SD card
  4. Instructions for Use
Materials required but not provided:
  1. Clock or timer
  2. RaFIA Immunofluorescence Analyzer
  3. RaFIA Immunofluorescence Incubator

Progesterone FIA Test

Features:
  • Quantitative, non-subjective results
  • Increased sensitivity and broader detection range compared to rapid tests
  1. Range
Working range: 0.30-80.00 ng/mL
  1. Precision
Intra-lot Precision Intra-lot precision was determined by testing of PROG reference materials using 10 test devices from the same lot. CV ≤ 15%. Inter-lot Precision Inter-lot precision was determined by testing of PROG reference materials using 30 test devices from 3 consecutive lots randomly (10 test devices from each lot). CV ≤ 20%.
  1. Accuracy
PROG control materials with two different concentrations were tested by every lot of test device, and the deviations were within ± 15%.
  1. Linearity
A serial concentration of PROG reference materials at 3.00-80.00 ng/mL was tested, and the correlation coefficient (R) is ≥ 0.9900.
  1. Specificity
Crossed Factors Concentration Test Result
Estradiol 500 ng/mL < 0.3 ng/mL
Testosterone 500 ng/mL < 0.3 ng/mL
Cortisol 500 ng/mL < 0.3 ng/mL
Aldosterone 500 ng/mL < 0.3 ng/mL
Estriol 100 ng/mL < 0.3 ng/mL
17-β Estradiol 100 ng/mL < 0.3 ng/mL
Oestrone 100 ng/mL < 0.3 ng/mL
17-α hydroxyl progesterone 100 ng/mL < 0.3 ng/mL
Reagents and Materials provided:
  1. Individually sealed foil pouches containing:
    1. One test device
    2. One desiccant
  2. Detection buffer tubes
  3. SD card
  4. Instructions for Use
Materials required but not provided:
  1. Clock or timer
  2. RaFIA Immunofluorescence Analyzer
  3. RaFIA Immunofluorescence Incubator

H. pylori Ab Combo Rapid Test CE

Features:
  • Uses serum, plasma or whole blood specimen
  • No need to avoid certain medications
  • Non-invasive, easy to perform procedure
  • Time to result is 15 minutes
  • Individually sealed foil pouches containing:
    • One cassette device
    • One desiccant
  • Plastic droppers
  • Sample diluent (REF SB-R0191, 5 mL)
  • Package insert (instruction for use)
CATALOG # PRODUCT QUANTOTY SPECIMEN

R0191C

 H. Pylori AB Combo Rapid Test CE

30/kit

S,P&WB

 

NT-proBNP FIA Test

Features:
  • Quantitative, non-subjective results
  • Increased sensitivity and broader detection range compared to rapid tests
RANGES:
  • Working range: 15–35000 pg/mL
PRECISION:
  • Intra-lot Precision: Intra-lot precision was determined by testing of NT-proBNP reference materials using 10 test devices from the same lot. CV ≤ 15%.
  • Inter-lot Precision: Inter-lot precision was determined by testing of NT-proBNP reference materials using 30 test devices from 3 consecutive lots randomly (10 test devices from each lot). CV ≤ 15%.
ACCURACY:
  • NT-proBNP control materials with two different concentrations were tested by every lot of test device, and the deviations were within ±15%.
LINEARITY:
  • A serial concentration of NT-proBNP reference materials at 15–35000 pg/mL was tested, and the correlation coefficient (R) is ≥0.9900.
REAGENTS AND MATERIALS PROVIDED:
  1. Individually sealed foil pouches containing: a. One test device b. One desiccant
  2. Detection buffer tubes
  3. SD card
  4. Instructions for Use
MATERIALS REQUIRED BUT NOT PROVIDED:
  1. Clock or timer
  2. RaFIA Immunofluorescence Analyzer
  3. RaFIA Immunofluorescence Incubator

FOB-Hi Rapid Test CE

  • Features:
    • Designed to specifically detect low levels of fecal occult blood, hHB ≥ 25 ng/mL
    • Higher accuracy, sensitivity and specificity than the Guaiac Test
    • No dietary restrictions
    • Clear, easy-to-interpret result
    • Individually sealed foil pouches containing:
      • One cassette test device
      • One desiccant
    • Stool collection devices, each containing 2 mL of extraction buffer (REF SB-R2011)
    • Patient ID stickers
    • One package insert (instruction for use)
    CATALOG # PRODUCT QUANTOTY SPECIMEN

    R2011C

    FOB-Hi Rapid Test

    25/kit

    Fecal

PRL FIA Test

Features:
  • Quantitative, non-subjective results
  • Increased sensitivity and broader detection range compared to rapid tests
RANGES
  • Working range: 5.0-4000.0 μIU/mL
PRECISION
  • Intra-lot Precision Intra-lot precision was determined by testing of PRL reference materials using 10 test devices from the same lot. CV ≤ 15%
  • Inter-lot Precision Inter-lot precision was determined by testing of PRL reference materials using 30 test devices from 3 consecutive lots randomly (10 test devices from each lot). CV ≤ 20%.
ACCURACY
  • PRL control materials with three different concentrations were tested by every lot of test device, and the deviations were within ±15%.
LINEARITY
  • A serial concentration of PRL reference materials at 5.0-4000.0 μIU/mL was tested, and the correlation coefficient (R) is ≥0.9900.
  • REAGENTS AND MATERIALS PROVIDED:
    1. Individually sealed foil pouches containing: a. One test device b. One desiccant
    2. Detection buffer tubes
    3. SD card
    4. Instructions for Use
    MATERIALS REQUIRED BUT NOT PROVIDED:
    1. Clock or timer
    2. RaFIA Immunofluorescence Analyzer
    3. RaFIA Immunofluorescence Incubator
CATALOG # PRODUCT QUANTITY SPECIMEN

F1080

PRL FIA Test

25/kit

Serum, Plasma
 

RIELE Photometer 5010

Features:
  • Type: Semi-automatic, single-beam filter photometer
  • Light Source: LED with long lifetime
  • Wavelength: 340 to 730nm; 6 standard filters + 3 optional filter of choice
  • Cuvette System: Micro flow cell; 32μl, 10 mm light path interchangeable with normal standard cuvettes (macro or semi-micro, disposable or special optical glass)
  • Aspiration System: Built-in peristaltic pump driven by stepper motor
  • Memory: Capacity for up to 231 programmable methods
  • Data Logging: up to 1000 test results can be saved
  • Quality Control: up to 50 methods, Levey-Jennings plot
  • Integrated Printer: Thermal printer, 24 characters per line