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FEATURE PRODUCTS
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
- Working range: 3.0-2000.0 ng/mL
- Intra-lot precision was determined by testing of AFP reference materials using 10 test devices from the same lot. CV ≤ 15%.
- 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%.
- AFP control materials with two different concentrations were tested by every lot of test device, and the deviations were within ±15%.
- 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:
- Individually sealed foil pouches containing:
- One test device
- One desiccant
- Detection buffer tubes
- SD card
- Instructions for Use
- Clock or timer
- RaFIA Immunofluorescence Analyzer
- RaFIA Immunofluorescence Incubator
- Individually sealed foil pouches containing:
AMH FIA Test
Features:
-
- Quantitative, non-subjective results
- Increased sensitivity and broader detection range compared to rapid tests
- Range
- Precision
- Accuracy
- Linearity
- Reagents and Materials provided:
- Individually sealed foil pouches containing:
- One test device
- One desiccant
- Detection buffer tubes
- SD card
- Instructions for Use
- Clock or timer
- RaFIA Immunofluorescence Analyzer
- RaFIA Immunofluorescence Incubator
- Individually sealed foil pouches containing:
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
- Intra-lot precision was determined by testing of CEA reference materials using 10 test devices from the same lot. CV ≤ 15%.
- 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%.
- CEA control materials with three different concentrations were tested by every lot of test device, and the deviations were within ±15%.
- A serial concentration of CEA reference materials at 1-500.0 ng/mL was tested, and the correlation coefficient (R) is ≥ 0.9900.
- There is no Hook effect when the level is 100000.0 ng/mL.
- Individually sealed foil pouches containing:
- One test device
- One desiccant
- Detection buffer tubes
- SD card
- Instructions for Use
- Clock or timer
- RaFIA Immunofluorescence Analyzer
- 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 |
CATEGORIES
MORE PRODUCTS
T4 FIA Test
Features:
- Quantitative, non-subjective results
- Increased sensitivity and broader detection range compared to rapid tests
- Range
- Precision
- Accuracy
- Linearity
- Specificity
- Individually sealed foil pouches containing:
- One test device
- One desiccant
- Detection buffer tubes
- SD card
- Instructions for Use
- Clock or timer
- RaFIA Immunofluorescence Analyzer
- RaFIA Immunofluorescence Incubator
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 |
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 |
PRL FIA Test
Features:
- Quantitative, non-subjective results
- Increased sensitivity and broader detection range compared to rapid tests
- Working range: 5.0-4000.0 μIU/mL
- 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%.
- PRL control materials with three different concentrations were tested by every lot of test device, and the deviations were within ±15%.
- 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:
- Individually sealed foil pouches containing: a. One test device b. One desiccant
- Detection buffer tubes
- SD card
- Instructions for Use
- Clock or timer
- RaFIA Immunofluorescence Analyzer
- RaFIA Immunofluorescence Incubator
| CATALOG # | PRODUCT | QUANTITY | SPECIMEN |
F1080 |
PRL FIA Test |
25/kit |
Serum, Plasma |
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 |
hCG Combo Rapid Test CE
Features:
-
- Clinical accuracy: In comparison with a reference chemiluminecsence or ELISA, hCG detection is
- 100% sensitivity and 100% specificity in urine specimens
- 100% sensitivity and 99.1% 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
-
- Individually sealed foil pouches containing:
a. One cassette device
b. One plastic dropper
c. One desiccant
- One package insert (instruction for use)
- Clinical accuracy: In comparison with a reference chemiluminecsence or ELISA, hCG detection is
| CATALOG # | PRODUCT | QUANTITY | SPECIMEN |
R1001C |
hCG Combo Rapid Test CE |
30/kit |
S/Urine |
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 |
D-Dimer FIA Test
Features:
- Quantitative, non-subjective results
- Increased sensitivity and broader detection range compared to rapid tests
- Working range: 0.1–10.0 mg/L
- Intra-lot Precision Intra-lot precision was determined by testing of D-Dimer reference materials using 10 test devices from the same lot. CV ≤ 15%.
- Inter-lot Precision Inter-lot precision was determined by testing of D-Dimer reference materials using 30 test devices from 3 consecutive lots randomly (10 test devices from each lot). CV ≤ 15%.
- D-Dimer control materials with three different concentrations were tested by every lot of test device, and the deviations were within ±15%.
- A serial concentration of D-Dimer reference materials at 0.1–10.0 mg/L was tested, and the correlation coefficient (R) is ≥0.9900.
- REAGENTS AND MATERIALS PROVIDED:
- Individually sealed foil pouches containing: a. One test device b. One desiccant
- Detection buffer tubes
- SD card
- Instructions for Use
- Clock or timer
- RaFIA Immunofluorescence Analyzer
- RaFIA Immunofluorescence Incubator
| CATALOG # | PRODUCT | QUANTITY | SPECIMEN |
F3010 |
D-Dimer FIA Test |
25/kit |
Serum, Plasma |