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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
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PSA Semi-quantitative Rapid Test

Features:
  • Non-invasive screening method for prostate cancer
  • Three-line test result to facilitate determination of patient’s PSA level
  • A cut-off value of 4 ng/mL and a reference value of 10 ng/mL for easy interpretation of the semi-quantitative test result
  • Individually sealed foil pouches containing:
    • One cassette device
    • One desiccant
  • Plastic droppers
  • Sample diluent (REF SB-R2002, 5 mL/bottle)
  • One package insert (instruction for use)
CATALOG # PRODUCT QUANTOTY SPECIMEN

R2002C

PSA Semi-Quantitative Rapid Test

30/kit

S, P & WB
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Rota/Adeno Ag Rapid Test CE

Features:
  • Stool collection device minimizes sample handling
  • Time saving differentiation between rotavrus and adenovirus in a single test
  • Result is available in 15 minutes
  • No cross-reactivity with other gastrointestinal infectious diseases
  • Individually sealed foil pouches containing:
    • One cassette device
    • One desiccant
  • Stool collection devices, each containing 2 mL extraction buffer
  • Plastic droppers (for transferring watery stool)
  • Patient ID stickers
  • Package insert (instruction for use)
CATALOG # PRODUCT QUANTOTY SPECIMEN

R0196C

 Rota/Adeno Ag Rapid Test CE

25/kit

Fecal
 
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Rotavirus Ag Rapid Test CE

Features:
  • Stool collection device minimizes sample handling
  • Utilizes a pair of specific antibodies to detect rotavirus antigen
  • Detects Group A rotavirus
  • Result is available in 15 minutes
  • No cross-reactivity with other gastrointestinal infectious diseases
  • Individually sealed foil pouches containing:
    • One cassette device
    • One desiccant
  • Stool collection devices, each containing 2 mL extraction buffer
  • Plastic droppers (for transferring watery stool)
  • Patient ID stickers
  • Package insert (instruction for use)
CATALOG # PRODUCT QUANTOTY SPECIMEN

R0194C

 Rotavirus Ag Rapid Test CE

25/kit

Fecal
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RSV Ag Rapid Test CE

  Features:
  • No cross-reactivity with 30+ common pathogens
  • 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
  • Individually sealed foil pouches containing:
    • One cassette device
    • One desiccant
  • Sample extraction tubes
  • Sample extraction buffer
  • Nozzle with Filter
  • Sterile swabs, each sealed in a plastic-paper pouch
  • Instructions for Use
CATALOG # PRODUCT QUANTITY SPECIMEN

R0186C

RSV Ag Rapid Test CE

20/kit

 Swab
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Rubella IgG/IgM Rapid Test

Features:
  • For obstetric and symptomatic patient screening, an easy to use, fast, cost-effective test for determining specific antibody levels for Rubella
  • The first rapid test to discriminate between patients at risk for, protected from or currently experiencing rubella infection
  • Four line format allows simultaneous detection of IgM and IgG anti-rubella virus saving time and cost
  • Single test differentiates high (≥250 IU/mL) and low (15-250 IU/mL) IgG anti-rubella virus levels, no need for ELISA test
  • Ten minute test time reduces result turn around time
  • Standardized with the WHO 1st International Standard for anti-rubella immunoglobulin (RUBI-1-94)
  • High correlation with ELISA results on the BBI Mixed Titer Performance Panel PTR-201
  • Individually sealed foil pouches containing:
    • One cassette device
    • One desiccant
  • Capillary tubes (10 µL)
  • Sample diluent (REF SB-R0243, 5 mL/bottle)
  • Package insert (instruction for use)
CATALOG # PRODUCT QUANTITY SPECIMEN

R0243C

Rubella IgG/IgM Rapid Test

30/kit

 S,P& WB
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S. Typhi/Paratyphi Ag Rapid Test

Features:
  • Detects the specific antigens from either S. typhi or S. paratyphi
  • Earlier detection results in faster treatment for disease eradication
  • Works with a variety of specimen types including: fecal, blood culture
  • Simple 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 at room temperature
  • Individually sealed foil pouches containing:
    • One cassette device
    • One desiccant
  • Stool collection devices, each containing 1 mL Fecal Sample Extraction Buffer (REF SB-R0162)
  • Sample diluent (REF SB-R0162-2, 5 mL/bottle)
  • Plastic droppers
  • Patient ID stickers
  • One package insert (instruction for use)
CATALOG # PRODUCT QUANTOTY SPECIMEN

R0162C

S.Typhi Paratyphi Ag Rapid Test

25/kit

Fecal Blood Culture
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Strep A Rapid Test (strip) CE

Features:
  • High confidence as test has no cross-reactivity with 22 common organisms
  • Convenient all-in-one package designed for use at point of care that requires minimal training
  • Safe for patients as it includes a CE marked high-quality reliable swab
  • Comfortable to handle with an ergonomic, user-friendly extraction tube that minimizes contamination
  • Initial patient care action can begin during the patient’s visit as results are available within 5 minutes
  • Individually sealed foil pouches containing:
    • One strip device
    • One desiccant
  • Sample extraction tubes
  • Sterile swabs, each sealed in a plastic-paper pouch
  • Extraction Reagent A (REF SB-R0184A,10 mL/bottle)
  • Extraction Reagent B (REF SB-R0184B,10 mL/bottle)
  • Strep A Positive Control (200 µL/vial)
  • Strep A Negative Control (200 µL/vial)
  • One package insert (instruction for use)
CATALOG # PRODUCT QUANTITY SPECIMEN

R0184S

Strep A Rapid Test (strip) CE

25/kit

 Swab
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T3 FIA Test

Features:
  • Quantitative, non-subjective results
  • Increased sensitivity and broader detection range compared to rapid tests
  1. Range
Working range: 0.5–10.0 nmol/L
  1. Precision
Intra-lot Precision Intra-lot precision was determined by testing of T3 reference materials using 10 test devices from the same lot. CV ≤ 15%. Inter-lot Precision Inter-lot precision was determined by testing of T3 reference materials using 30 test devices from 3 consecutive lots randomly (10 test devices from each lot). CV ≤ 20%.
  1. Accuracy
T3 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 T3 reference materials at 0.8-10.0 nmol/L was tested, and the correlation coefficient (R) is ≥ 0.9900.
  1. Specificity
The concentration of T3 is not greater than 1.0 nmol/L when the concentration of T4 is 500.0 ng/mL. The concentration of T3 is not greater than 1.0 nmol/L when the concentration of rT3 is 50.0 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
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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
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TB IgG/IgM Combo Rapid Test CE

  Features: A lateral flow chromatographic immunoassay for the simultaneous detection and differentiation of IgM and IgG anti-Mycobacterium tuberculosis (anti-M. TB)  in human serum, plasma or whole blood.
  • Individually sealed foil pouches containing:
    • One cassette device
    • One desiccant
  • Plastic droppers
  • Sample diluent (REF SB-R0053, 5 mL/bottle)
  • One package insert (instruction for use)
CATALOG # PRODUCT QUANTITY SPECIMEN

R0053C

TB IgG/IgM Combo Rapid Test CE

30/kit

 S, P &WB
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Testosterone FIA Test

Features:
  • Quantitative, non-subjective results
  • Increased sensitivity and broader detection range compared to rapid tests
  1. Range
Working range: 0.2-20.0 ng/mL
  1. Precision
Intra-lot Precision Intra-lot precision was determined by testing of TES reference materials using 10 test devices from the same lot. CV ≤ 15%. Inter-lot Precision Inter-lot precision was determined by testing of TES reference materials using 30 test devices from 3 consecutive lots randomly (10 test devices from each lot). CV ≤ 20%.
  1. Accuracy
TES 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 TES reference materials at 0.2-20.0 ng/mL was tested, and the correlation coefficient (R) is ≥ 0.9900.
  1. Specificity
Crossed Factors Concentration Test Result
Progesterone 500 ng/mL < 0.2 ng/mL
Estradiol 100 ng/mL < 0.2 ng/mL
Cortisol 500 ng/mL < 0.2 ng/mL
Aldosterone 500 ng/mL < 0.2 ng/mL
Estriol 100 ng/mL < 0.2 ng/mL
17α-Estradiol 500 ng/mL < 0.2 ng/mL
Oestrone 50 ng/mL < 0.2 ng/mL
Reagents and Materials provided:
  1. Individually sealed foil pouches containing:
    • One test device
    • 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
Add to wishlist
Read more