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TORCH Panel Rapid Test

Features:
    • Distinguishes between IgG and IgM in all five TORCH infections
    • Compatible with serum, plasma, and whole blood
    • Results available in 15 minutes
    • Provides semi-quantitative results for Rubella IgG antibodies
    • Distinguishes between HSV-1 and HSV-2
    • Shelf life: 18 months
    • Analytical Sensitivity of IgG Detection: Twenty negative specimens were spiked with appropriate reference standards at various concentrations. Specimens were run on the OnSite TORCH Panel Rapid Test panel member. Defined as the 95% detection level, the limits of detection, or sensitivity, were determined to be as follows:
    1. Toxo: 5 IU/mL LOD; WHO International Standard Anti-Toxoplasma Serum Ig (TOXM)
    2. Rubella: 15 IU/mL (G1); 250 IU/mL (G2); WHO 1st International Standard (RUBI-1-94)
    • Accuracy of IgG Detection in comparison with commercial ELISA: Clinical IgG positive specimens were collected and tested on each OnSite TORCH Panel Rapid Test panel member as well as by commercial ELISA. Comparison for all subjects showed the following overall agreements:
    1. Toxo (237 specimens): 94.9%
    2. Rubella (214 specimens): 97.7%
    3. CMV (258 specimens): 93.4%
    4. HSV-1 (227 specimens): 90.7%
    5. HSV-2 (214 specimens): 95.3%
    • Accuracy of IgM Detection in comparison with commercial ELISA: Clinical IgM positive specimens  were collected and tested on each OnSite TORCH Panel Rapid Test  panel  member  as  well  as  by  commercial    Comparison  for  all  subjects  showed  the following overall agreements:
    1. Toxo (231 specimens): 98.8%
    2. Rubella (25 specimens): 96.0%
    3. CMV (212 specimens): 93.9%
    4. HSV-1 (107 specimens): 85.0%
    5. HSV-2 (26 specimens): 95.2%
    • Cross Reactivity: No false positive IgG and IgM results were observed on 3-14 specimens from the following disease states or special conditions, respectively: Toxo, Rubella, CMV, HSV-1, HSV-2, hCG, HAV, HBV, HCV, HEV, HIV, TB, palladium, Dengue, Malaria, H. pylori, Typhoid, ANA, HAMA, and RF (>1,000 IU/mL).
    During cross-reactivity testing for each TORCH infection, self-reactivity was not considered (i.e. rubella positive samples were not tested on the Rubella IgG/IgM Rapid Test). Specimens tested vary for each panel member of the OnSite TORCH Panel Rapid Test.
    • Interference: No interference was seen from the following substances: Albumin 60 g/L; Bilirubin 20 mg/dL; Heparin 3,000 U/L; Hemoglobin 2 g/L; Creatinine 442 µmol/L; EDTA 3.4 µmol/L; Salicylic acid 4.34 mmol/L; Glucose 55 mmol/L; and Sodium citrate 3.8%.
  • Individually sealed foil pouches containing:
    • One cassette device
    • Two desiccants
  • Plastic droppers
  • Sample diluent (REF SB-R0253, 5 mL/bottle)
  • One package insert (instruction for use)
CATALOG # PRODUCT QUANTITY SPECIMEN

R0253C

TORCH Panel Rapid Test

10/kit

 S,P& WB
 
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Total IgE FIA Test

Features: Quantitative, non-subjective results • Increased sensitivity and broader detection range compared to rapid tests
  1. Range
Working range: 1.0-1000.0 IU/mL
  1. Precision
Intra-lot Precision Intra-lot precision was determined by testing of IgE reference materials using 10 test devices from the same lot. CV ≤ 15%. Inter-lot Precision Inter-lot precision was determined by testing of IgE reference materials using 30 test devices from 3 consecutive lots randomly (10 test devices from each lot). CV ≤ 15%.
  1. Accuracy
IgE 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 IgE reference materials at 1.0-1000 IU/mL was tested, and the correlation coefficient (R) is ≥ 0.9900.
  1. Specificity
No cross reactivities were observed while testing following immunoglobulins with indicated concentrations:
Immunoglobulins Concentrations Test Results
IgG 200 mg/mL ≤ 1.0 IU/mL
IgA 20 mg/mL ≤ 1.0 IU/mL
IgM 20 mg/mL ≤ 1.0 IU 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
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Total Vitamin D FIA Test

Features:
  • Quantitative, non-subjective results
  • Increased sensitivity and broader detection range compared to rapid tests
  1. Range
Working range: 5.0-120.0 ng/mL
  1. Precision
Intra-lot Precision Intra-lot precision was determined by testing of Vitamin D reference materials using 10 test devices from the same lot. CV ≤ 15%. Inter-lot Precision Inter-lot precision was determined by testing of Vitamin D reference materials using 30 test devices from 3 consecutive lots randomly (10 test devices from each lot). CV ≤ 20%.
  1. Accuracy
Vitamin D 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 Vitamin D reference materials at 5.0-120.0ng/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. Solution A tube
  4. Solution B tube
  5. SD card
  6. Instructions for Use
  Materials required but not provided:
  1. Clock or timer
  2. RaFIA Immunofluorescence Analyzer
  3. RaFIA Immunofluorescence Incubator
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Toxo IgG/IgM Combo Rapid Test

Features:
  • A lateral flow chromatographic immunoassay for the simultaneous detection and differentiation of IgG and IgM anti-Toxoplasma gondii (T. gondii) 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-R0234, 5 mL/bottle)
    • One package insert (instruction for use)
CATALOG # PRODUCT QUANTITY SPECIMEN

R0234C

Toxo IgG/IgM Combo Rapid Test

30/kit

 S, P &WB
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tPSA FIA Test

Features:
  • Quantitative, non-subjective results
  • Increased sensitivity and broader detection range compared to rapid tests
  1. Range
Working range: 0.5-200.0 ng/mL
  1. Precision
Intra-lot Precision Intra-lot precision was determined by testing of tPSA reference materials using 10 test devices from the same lot. CV ≤ 15%. Inter-lot Precision Inter-lot precision was determined by testing of tPSA reference materials using 30 test devices from 3 consecutive lots randomly (10 test devices from each lot). CV ≤ 20%.
  1. Accuracy
tPSA 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 tPSA reference materials at 0.5-200.0 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
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Troponin I Combo Rapid Test CE

Features:
  • Clinical performance:
    • Relative Sensitivity: 95.8% (95% CI: 91.5-97.9%) compared to a reference CLIA
    • Relative Specificity: 99.7% (95% CI: 98.8-99.9%)
  • Analytical sensitivity: The detection limit of cTnI is 1.0 ng/mL or greater in serum, plasma or whole blood specimen
  • Cross-reactivity: No cross reactivity with 10 µg/mL skeletal muscle TnI, 2,000 ng/mL cardiac muscle TnT, 20 µg/mL cardiac muscle Myosin
  • Dose hook effect: No hook effect was observed for cTnI at concentrations up to 3,521 µg/mL
  • Interference: No interference was seen with 20 mg/dl Acetaminophen, 20 mg/dl Acetylsalicylic acid, 10.5 g/dl Albumin, 20 mg/dl Ascorbic acid, 1,000 mg/dl Bilirubin, 20 mg/dl Caffeine, 800 mg/dl Cholesterol, 200 mg/dl Creatinine, 20 mg/dl Gentistic acid, 1,000 mg/dl Hemoglobin, 600 mg/dl Oxilic acid, 1,600 mg/dl Triglycerides
  • Shelf life: 24 months
  • Individually sealed foil pouches containing:
    • One cassette device
    • One desiccant
  • Plastic droppers
  • Sample diluent (REF SB-R3002, 5 mL/bottle)
  • One package insert (instruction for use)
CATALOG # PRODUCT QUANTOTY SPECIMEN

R3002C

Troponin I Combo Rapid Test CE

30/kit

S, P & WB
 
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TSH FIA Test

Features:
  • Quantitative, non-subjective results
  • Increased sensitivity and broader detection range compared to rapid tests
RANGES
  • Working range: 0.4–100.0 μIU/mL
PRECISION
  • Intra-lot Precision: Intra-lot precision was determined by testing of TSH reference materials using 10 test devices from the same lot. CV ≤ 15%.
  • Inter-lot Precision: Inter-lot precision was determined by testing of TSH reference materials using 30 test devices from 3 consecutive lots randomly (10 test devices from each lot). CV ≤20%.
ACCURACY 
  • TSH 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 TSH reference materials at 0.4-100.0 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

F1030

TSH FIA Test

25/kit

 Serum, Plasma
 
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Typhoid IgG/IgM Combo Rapid Test CE

Features:
  • Utilizes O antigen and H antigen from both typhi and paratyphi serovars to maximize sensitivity
  • Differentiates between IgG and IgM to determine stage of infection
  • One step procedure minimizes operator error due to sample preparation
  • Test result within 15 minutes allows medical professionals to take immediate action
  • High level of reproducibility
  • Test kits can be used and stored in a wide range of temperatures
  • Individually sealed foil pouches containing:
    • One cassette device
    • One desiccant
  • Plastic droppers
  • Sample Diluent (REF SB-R0161, 5 mL/bottle)
  • Package insert (instruction for use)
CATALOG # PRODUCT QUANTOTY SPECIMEN

R0161C

Typhoid IgG/IgM Combo Rapid Test

30/kit

S,P &WB
 
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β-hCG FIA Test

Features:
  • Quantitative, non-subjective results
  • Increased sensitivity and broader detection range compared to rapid tests
RANGES:
  • Working range: 5.0-200000.0 mIU/mL
PRECISION:
  • Intra-lot Precision: Intra-lot precision was determined by testing of β-hCG reference materials using 10 test devices from the same lot. CV ≤ 15%.
  • Inter-lot Precision: Inter-lot precision was determined by testing of β-hCG reference materials using 30 test devices from 3 consecutive lots randomly (10 test devices from each lot). CV ≤ 20%.
ACCURACY:
  •  β-hCG 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 β-hCG reference materials at 5.0-200000.0 mIU/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
    4. 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

F1000

β-hCG FIA Test

25/kit

 Serum, Plasma
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