Showing 1–12 of 69 results

Adenovirus Ag Rapid Test CE

Features:
  • No cross-reactivity with 30+ common bacteria and viruses.
  • CE mark approved for sale in Europe
  • Ergonomic, user-friendly extraction tube that minimizes contamination
  • Initial patient care action can begin during the patient’s visit as positive results are visible in as soon as 3 minutes
CATALOG # PRODUCT QUANTITY SPECIMEN

R0189C

Adenovirus Ag Rapid Test CE

20/kit

Swab
 

AFP FIA Test

Features:
  • Quantitative, non-subjective results
  • Increased sensitivity and broader detection range compared to rapid tests
Range
  • Working range: 3.0-2000.0 ng/mL
Precision Intra-lot Precision
  •  Intra-lot precision was determined by testing of AFP reference materials using 10 test devices from the same lot. CV ≤ 15%.
Inter-lot Precision
  • Inter-lot precision was determined by testing of AFP reference materials using 30 test devices from three consecutive lots randomly (10 test devices from each lot). CV ≤ 15%.
Accuracy
  • AFP 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 AFP controls at 3.0-2000.0 ng/mL was tested, and the correlation coefficient (R) is ≥ 0.9900.
  • 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
 

AMH FIA Test

Features:
    • Quantitative, non-subjective results
    • Increased sensitivity and broader detection range compared to rapid tests
    1. Range
    Working range: 0.1-25.0 ng/mL
    1. Precision
    Intra-lot Precision Intra-lot precision was determined by testing of AMH reference materials using 10 test devices from the same lot. CV ≤ 10%. Inter-lot Precision Inter-lot precision was determined by testing of AMH reference materials using 30 test devices from 3 consecutive lots randomly (10 test devices from each lot). CV ≤ 15%.
    1. Accuracy
    AMH 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 AMH reference materials at 0.1-25.0 ng/mL was tested, and the correlation coefficient (R) is ≥ 0.9900.
  • 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

CEA FIA Test

Features:
      • Quantitative, non-subjective results
      • Increased sensitivity and broader detection range compared to rapid tests
      • Range
        •  Working range: 0.5-500.0 ng/mL
        Precision  Intra-lot Precision
        •  Intra-lot precision was determined by testing of CEA reference materials using 10 test devices from the same lot.  CV ≤ 15%.
        Inter-lot Precision
        •  Inter-lot precision was determined by testing of CEA reference materials using 30 test devices from three consecutive lots randomly (10 test devices from each lot). CV ≤ 20%.
        Accuracy
        • CEA 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 CEA reference materials at 1-500.0 ng/mL was tested, and the correlation coefficient (R) is ≥ 0.9900.
        Hook Effect
        •  There is no Hook effect when the level is 100000.0 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

Chagas Ab Combo Rapid Test CE

Features:
  • First lateral flow rapid test on the market for Chagas, suitable for use at the point of care
  • No equipment required
  • Simple procedure
  • Detects antibodies including IgG to T. cruzi
  • Utilizes recombinant antigens to achieve high sensitivity and specificity
  • Relative Sensitivity: 92.9%, Relative Specificity: 100% in comparison to a commercial EIA
  • Individually sealed foil pouches containing:
    • One cassette device
    • One desiccant
  • Plastic droppers
  • Sample diluent (REF SB-R0171, 5 mL/bottle)
  • One package insert (instruction for use)
CATALOG # PRODUCT QUANTITY SPECIMEN

R0171C

Chagas Ab Combo Rapid Test CE

30/kit

S, P &WB

Chikungunya IgM Combo Rapid Test CE

Features:
  • 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)
CATALOG # PRODUCT QUANTITY SPECIMEN

R0066C

Chikungunya IgM Combo Rapid Test CE

30/kit

S, P &WB
 

CK-MB FIA Test

Features:
        • Quantitative, non-subjective results
        • Increased sensitivity and broader detection range compared to rapid tests
        RANGES
        • Working range: 1.0-80.0 ng/mL
        PRECISION
        • Intra-lot Precision Intra-lot precision was determined by testing of CK-MB reference materials using 10 test devices from the same lot. CV ≤ 15%.
        • Inter-lot Precision Inter-lot precision was determined by testing of CK-MB reference materials using 30 test devices from 3 consecutive lots randomly (10 test devices from each lot). CV ≤ 15%.
        ACCURACY
        • CK-MB 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 CK-MB reference materials at 2.5-80.0 ng/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

CMV IgG/IgM Rapid Test

Features:
  • A lateral flow immunoassay for the simultaneous detection and differentiation of IgM and IgG antibodies to cytomegalovirus (CMV) in human serum, plasma or whole blood.
    • Individually sealed foil pouches containing:
    a. One cassette device b. One desiccant
    • 10 µL capillary tubes
    • Sample diluent (REF SB-R0224, 5 mL/bottle)
    • One package insert (instructions for use)
CATALOG # PRODUCT QUANTITY SPECIMEN

R0224C

CMV IgG/IgM Rapid Test

30/kit

S,P& WB
 

COVID-19 + Influenza A/B Ag Rapid Test CE

Features:
  • Aids in identifying SARS-CoV-2, Influenza A, and Influenza B infection, within the first seven days of symptom onset.
  • Differentiates 3 infections in 1 test.
  • Efficiently tests for 3 infections with only 1 patient sample.
  • Easy to use, minimal training required, no lab equipment needed.
  • All-in-one package for point-of-care use and resource-limited settings.
  • Results in 15 minutes.
  • Reagents and Materials Provided:
    1. Individually sealed foil pouches containing:
      1. Two cassettes assembled into one panel
      2. One desiccant
    2. Sample extraction tubes
    3. Sample extraction tube rack
    4. Sample extraction buffer (REF SB-R0188, 5 mL/bottle)
    5. Nozzles with filter
    6. Individually sealed pouches containing a sterile swab
    7. Instructions for Use
    Materials Required but Not Provided:
    • Clock or timer
    Materials May be Required but Not Provided:
    • Positive control
    • Negative Control
    • Nasal Swabs
CATALOG # PRODUCT QUANTITY SPECIMEN

R0188C

COVID-19 + Influenza A/B Ag Rapid Test CE

15/kit

Swab

COVID-19 Ab Rapid Test

Features:
  • The OnSite COVID-19 Ab Rapid Test is designed to detect anti-SARS-CoV-2 total antibodies in either serum, plasma or whole blood within 15 minutes. It is presumed that the OnSite COVID-19 Ab Rapid Test may detect SARS-CoV-2 in other species of mammals including mink.
  • This test is easy to use and does not require the use of laboratory equipment.
  • 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

R0185C

COVID-19 Ab Rapid Test

30/kit

S, P &WB
 

COVID-19 Ag Rapid Test CE

  Features:
  • The OnSite COVID-19 Ag Rapid Test has 92.3% sensitivity and 100% specificity, aiding in early diagnosis by detecting viral components.
  • The OnSite COVID-19 Ag Rapid Test is a qualitative antigen detection test that provides results in 15 minutes.
  • This test is easy to use and does not require the use of laboratory equipment.
  • 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 a database
    • Reagents and Materials Provided:
      1. Individually sealed foil pouches containing:
        1. One cassette device
        2. One desiccant
      2. Sample extraction tubes
      3. Sample extraction tube rack
      4. Sample extraction buffer
      5. Nozzles
      6. Sterile swabs, each sealed in a plastic-paper pouch
      7. Instructions for Use
      Materials Required but Not Provided:
      • Clock or timer
      Materials May be Required but Not Provided:
      • Positive control
      • Negative control
      • Nasal swab
CATALOG # PRODUCT QUANTITY SPECIMEN

R0182C

COVID-19 Ag Rapid Test CE

20/kit

Swab

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