CRP FIA Test
Features:
-
- Quantitative, non-subjective results
- Increased sensitivity and broader detection range compared to rapid tests
- Working range: 2.5–200 mg/L
- Intra-lot Precision Intra-lot precision was determined by testing of CRP reference materials using 10 test devices from the same lot. CV ≤ 15%.
- Inter-lot Precision Inter-lot precision was determined by testing of CRP reference materials using 30 test devices from 3 consecutive lots randomly (10 test devices from each lot). CV ≤ 20%.
- CRP control materials with three different concentrations were tested by every lot of test device, and the deviations were within ±15%.
- A serial concentration of CRP reference materials at 2.5–200 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 |
F0410 |
CRP FIA Test |
25/kit |
Serum, Plasma, Whole blood |
cTnI FIA Test
Features:
- Quantitative, non-subjective results
- Increased sensitivity and broader detection range compared to rapid tests
- Working range: 0.1–50.00 ng/mL
- Intra-lot Precision: Intra-lot precision was determined by testing of cTnI reference materials using 10 test devices from the same lot. CV ≤ 15%.
- Inter-lot Precision: Inter-lot precision was determined by testing of cTnI reference materials using 30 test devices from 3 consecutive lots randomly (10 test devices from each lot). CV ≤ 15%.
- cTnI control materials with two different concentrations were tested by every lot of test device, and the deviations were within ±15%.
- A serial concentration of cTnI reference materials at 0.1–50.00 ng/mL was tested, and the correlation coefficient (R) is ≥0.9900.
-
- 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 |
F3002 |
cTnI FIA Test |
25/kit |
Plasma, Whole blood |
Cys-C FIA Test
Features:
-
- Quantitative, non-subjective results
- Increased sensitivity and broader detection range compared to rapid tests
- Working range: 0.2-8.0 mg/L
- Intra-lot precision was determined by testing of Cys-C reference materials using 10 test devices from the same lot. CV ≤ 15%.
- Inter-lot precision was determined by testing of Cys-C reference materials using 30 test devices from three consecutive lots randomly (10 test devices from each lot). CV ≤ 20%.
- Cys-C control materials with three different concentrations were tested by every lot of test device, and the deviations were within ±15%.
- A serial concentration of Cys-C reference materials at 0.4-8.0 mg/L was tested, and the correlation coefficient (R) is ≥ 0.9900.
-
- 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:
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 |
Dengue Ag Rapid Test CE
Features:
- In-house developed fourth generation rapid test aids in the diagnosis of an early acute infection, including primary or secondary infection
- Detects NS1 antigen from all four dengue serotypes (DEN1, 2, 3, 4) in human serum, plasma or whole blood specimen
- Simple assay procedure yields results within 20-25 minutes
- Limit of Detection: detection of NS1 protein in all 4 types of dengue virus lysate I, II, III, and IV. The limit of detection is 0.25 ng/mL as determined on recombinant dengue NS1 antigen from serotype 2 (DEN2)
- Sensitivity: 100%
- Specificity: 98.8% comparing to a commercial ELISA
- Cross-Reactivity: no cross-reactivity found on 6-10 positive specimens from the 21 disease states, such as chikungunya, ZIKV, malaria, leishmania, Typhoid and others
- No interference with some common substances, such as Albumin (60 g/L), Bilirubin (20 mg/dL), Creatinine (442 µmol/L), EDTA (3.4 µmol/L), Glucose (55 mmol/L), Heparin (3,000 U/L), Salicylic acid (4.34 mmol/L), Sodium citrate (3.8%), Human IgG (1,000 mg/dL)
- Dose Hook Effect: No hook effect was detected with dengue NS1 antigen concentration up to 200 μg/mL during the study.
- Individually sealed foil pouches containing:
- One cassette device
- One desiccant
- Plastic droppers
- Sample diluent (REF SB-R0063, 5 mL/bottle)
- One package insert (instruction for use)
| CATALOG # | PRODUCT | QUANTITY | SPECIMEN |
R0063C |
Dengue Ag Rapid Test CE |
30/kit |
S, P &WB |
Dengue IgG/IgM Combo Rapid Test CE
Features:
- Utilizes recombinant chimeric dengue virus licensed from the US CDC
- Detects all four dengue serotypes
- IgM detection indicates recent infection
- IgG detection indicates recent or previous infections
- Individually sealed foil pouches containing:
- One cassette device
- One desiccant
- 5 µL capillary tubes
- Sample diluent (REF SB-R0061, 5 mL/bottle)
- One package insert (instruction for use)
| CATALOG # | PRODUCT | QUANTITY | SPECIMEN |
R0061C |
Dengue IgG/IgM Combo Rapid Test CE |
30/kit |
S, P &WB |
Duo Dengue Ag-IgG/IgM Rapid Test CE
Features:
- Utilizes recombinant chimeric dengue virus licensed from the US CDC
- Detects all four dengue serotypes
- Duo test format minimizes processing time
- IgM detection indicates recent infection
- IgG detection indicates recent or previous infections
- Ag detection indicates a current infection
- Individually sealed foil pouches containing:
- One cassette device
- One desiccant
- 5 µL Capillary tubes (for Dengue IgG/IgM test)
- Plastic droppers (for Dengue Ag test)
- Sample diluent (REF SB-R0062, 5 mL/bottle)
- One package insert (instruction for use)
| CATALOG # | PRODUCT | QUANTITY | SPECIMEN |
R0062C |
Duo Dengue Ag-IgG/IgM Rapid Test CE |
30/kit |
S, P &WB |
Duo HSV-1/2 IgG/IgM Rapid Test CE
Features:
- Clinical accuracy:
- 90.6% sensitivity and 91.4% specificity for anti-HSV-1 IgG detection
- 93.8% sensitivity and 96.0% specificity for anti-HSV-2 IgG detection
- 85.0% overall agreement for anti-HSV-1 IgM detection comparing to commercial ELISA
- 100% overall agreement for anti-HSV-2 IgM detection comparing to BBI Panel (PTH202)
- Positive rate on random clinical specimens:8% for IgG anti-HSV-1 and 4.9% for IgM anti-HSV-1 (n=10,000); 4.6% for anti-HSV-2 IgG and 1.7% for anti-HSV-2 IgM
- Cross reactivity: no cross reactivity with the following disease states or special conditions, respectively: palladium, H. pylori, Dengue, Malaria, Typhoid, Toxoplasma, Rubella, CMV, hCG, TB, HAV, HBV, HCV, HEV, HIV, ANA, HAMA, RF (up to 1,000 IU/mL)
- Interference: No interference was seen with Albumin 60 g/L , Hemoglobin 2 g/L, Bilirubin 20 mg/dL, Heparin 3,000 U/L, Creatinine 442 µmol/L, Salicylic acid 4.24 mmol/L, EDTA 3.4 µmol/L, Sodium citrate 8%, Glucose 55 mmol/L
- Shelf life: 24 months
- ndividually sealed foil pouches containing:
- One cassette device
- One desiccant
- Capillary tubes (10 µL)
- Sample diluent (REF SB-R0203, 5 mL/bottle)
- Package insert (instruction for use)
| CATALOG # | PRODUCT | QUANTOTY | SPECIMEN |
R0218C |
Duo HSV-1-2IgG/IgM Rapid Test CE |
20/kit |
S,P& WB |
Ferritin FIA Test
Features:
- Quantitative, non-subjective results
- Increased sensitivity and broader detection range compared to rapid tests
- Working range: 1.0-1000.0 ng/mL
- Intra-lot Precision Intra-lot precision was determined by testing of Ferritin reference materials using 10 test devices from the same lot. CV ≤ 15%.
- Inter-lot Precision Inter-lot precision was determined by testing of Ferritin reference materials using 30 test devices from 3 consecutive lots randomly (10 test devices from each lot). CV ≤ 20%.
- Ferritin control materials with three different concentrations were tested by every lot of test device, and the deviations were within ±15%.
- A serial concentration of Ferritin reference materials at 2.0-1000.0 ng/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 |
F5010 |
Ferritin FIA Test |
25/kit |
Serum, Plasma |
FOB Rapid Test CE
Features:
- Designed to specifically detect low levels of fecal occult blood, hHB ≥ 50 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-R2010)
- Patient ID stickers
- One package insert (instruction for use)
-
CATALOG # PRODUCT QUANTOTY SPECIMEN R2010C
FOB Rapid Test
25/kit
Fecal
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
fPSA FIA Test
Features:
- Quantitative, non-subjective results
- Increased sensitivity and broader detection range compared to rapid tests
- Working range: 0.1-30.0 ng/mL
- Intra-lot precision was determined by testing of fPSA reference materials using 10 test devices from the same lot. CV ≤ 15%.
- Inter-lot precision was determined by testing of fPSA reference materials using 30 test devices from three consecutive lots randomly (10 test devices from each lot). CV ≤ 20%.
- fPSA control materials with three different concentrations were tested by every lot of test device, and the deviations were within ±15%.
- A serial concentration of fPSA reference materials at 0.1-30.0 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: