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:
- Individually sealed foil pouches containing:
- One cassette device
- One desiccant
- Disposable capillary tubes, marked for 10 µL and 20 µL
- Detection buffer (tris-based buffered solution with preservatives)
- Instructions for Use
- Clock, watch or other timing device
- Pipettor capable of delivering 10-20 μL of sample, that can be used instead of the disposable capillary tube for greater accuracy
- Sterile lancets, sterile gauze and wipes for fingerstick whole blood specimens
- Collection devices for venous whole blood, serum, plasma
- Disposable gloves, biohazard disposal container
- Individually sealed foil pouches containing:
| CATALOG # | PRODUCT | QUANTITY | SPECIMEN |
R0180C |
COVID-19 IgG/IgM Rapid Test CE |
30/kit |
S, P &WB |
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 |
DiaSys Respons 920
Features:
- System Type: Automated bench top random access clinical chemistry analyzer
- Throughput: 200 test per hour with a cycle time of 18 seconds for mono and two component tests
- Sample tray: 30 sample positions including STAT positions, 9 positions for blank, controls and calibrators
- Reagent on-board capacity: 30 different methods in bar coded mono or twin containers, refrigerated
- Reaction Unit: temperature controlled heated rotor with 45 reusable quartz glass cuvettes (37 ± 0.2°C)
- Photometry: 8 wavelengths (340, 405, 450,505, 546, 578, 660 and 700nm (mono and bichromatic))
DiaSys Respons 940
Features:
- System Type: Automated random access clinical chemistry analyzer
- Throughput: 400 test per tests, independently for mono and two component reagents
- Sample disk: 80 positions for samples, blanks, standards, calibrators, controls, STAT samples
- Reagent on-board capacity: 72 reagent positions (R1+R2), refrigerated
- Reaction Unit: 72 permanent hard glass cuvettes (37 ± 0.2°C)
- Photometry: 12 wavelengths (340, 376, 415, 450, 480, 505, 546, 570, 600, 660, 700 and 705 nm)
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 |
Edan i15 Blood Gas and Chemistry Analyzer
Features:
- Innovative microchip liquid control technology and micro-sensor multifunction membrane technology
- Multi-parameter cartridge, including ABG, electrolytes and metabolites
- Throughput: result in 1 minute after sample aspiration
- Display: 7-inch color LCD Touch Screen Display
- Data Storage: up to 10,000 patient results