Influenza A/B Ag Rapid Test CE
Features:
- Simple test procedure
- Detection and differentiation of Influenza A and B virus, including H5N1 and H1N1
- Efficient, easy-to-interpret results
- No equipment required
- Results in only 10 minutes
- Multiple specimen collection options
- Compatibility with CTK’s Rapid Test Reader
- External Positivia controls available separately
- Individually sealed foil pouches containing:
- One cassette device
- One desiccant
- Sample extraction tubes
- Sample extraction tube rack
- Sample extraction buffer
- Nozzles with Filter
- Sterile swabs, each sealed in a plastic-paper pouch
- Instructions for Use
| CATALOG # | PRODUCT | QUANTITY | SPECIMEN |
R0187C |
Influenza A/B Ag Rapid Test CE |
20/kit |
Swab |
Influenza A/B Rapid Test (strip) CE
Features:
- Single test that reliably detects the most common types of influenza – type A and B virus, including H1N1 (swine flu) and H5N1 (bird flu)
- High quality CE marked and approved for sale in Europe
- Comfortable and durable with a small, soft swab tip that is ideal for use with children
- Initial patient care action can begin during patient’s visit as results are available within 10 minutes
- Individually sealed foil pouches containing:
- One strip device
- One desiccant
- Sample extraction tubes, each containing 0.3 mL of extraction buffer (REF SB-R0187)
- Sterile swabs, each sealed in a plastic-paper pouch
- One package insert (instruction for use)
| CATALOG # | PRODUCT | QUANTITY | SPECIMEN |
R0187S |
Influenza A/B Rapid Test (strip) CE |
25/kit |
Swab |
Influenza A/B Rapid Test with Positivia External Control CE
Features:
OnSite Influenza A/B Rapid Test
- Single test that reliably detects the most common types of Influenza – type A and B virus, including H1N1 (swine flu) and H5N1 (bird flu)
- High quality, approved for sale in Europe through CE marking
- Comfortable and durable, with a small, soft swab tip that is ideal for use with children
- Initial patient care action can begin during patient’s visit as results are available within 10 minutes
- Robust performance, approved for sale in Europe through CE marking
- Enough materials to perform 3 sets of control tests (Influenza A, Influenza B and Negative)
- Uses the same test procedure as clinical specimens for quality control consistency and user convenience
- Room temperature shipping and storage
- Includes 3 additional individually packed strip tests (for controls)
- Individually sealed foil pouches containing:
- One strip device
- One desiccant
- 3 additional individually packed strip tests (for controls)
- Sample extraction tubes
- Sample extraction tube rack
- Sample extraction buffer (REF SB-R0187)
- Sterile swabs, each sealed in a plastic-paper pouch
- Positivia External Control Kit containing:
- One Influenza A Positive Control
- One Influenza B Positive Control
- One Influenza A/B Negative Control
- Three Extraction Tubes
- Instructions for Use
| CATALOG # | PRODUCT | QUANTITY | SPECIMEN |
R0181S |
Influenza A/B Rapid Test with Positivia External Control CE |
25/kit |
Swab |
Leishmania Ab Rapid Test CE
Features:
- No equipment required
- Simple procedure
- Detects both IgG and IgM to L. donovani
- Utilizes rK39 antigen to achieve high sensitivity and specificity
- Individually sealed foil pouches containing:
- One strip device
- One desiccant
- 5 µL capillary tubes
- Sample diluent (REF SB-R0122, 5 mL/bottle)
- One package insert (instruction for use)
| CATALOG # | PRODUCT | QUANTITY | SPECIMEN |
R0122S |
Leishmania Ab Rapid Test CE |
30/kit |
S, P |
Leptospira IgG/IgM Combo Rapid Test
Features:
- Accuracy: 100% specificity and 100% sensitivity in comparison with a reference rapid test on the market
- Cross Reactivity: No false positive results were observed on specimens from TP, HIV, Dengue, TB, Typhoid Ab , HBsAg, HCV Ab, HEV Ab, H.P Ab, HAV, HCG, RF, ANA, HAMA
- Interference: No interference were seen with substances: Salicylic acid: 4.34 mmol/L; Glucose: 55 mmol/L; Sodium citrate: 3.8 %; Heparin: 3,000 U/L; Creatinine: 442 μmol/L; Bilirubin: 20 mg/dL; EDTA: 3.4 μmol/L; Hemoglobin: 2g/L; Human IgG: 1000 mg/dL; AlbuminL 60 g/L
- Shelf life: 24 month
- Individually sealed foil pouches containing:
- One cassette device
- One desiccant
- 5 μL capillary tubes
- Sample diluent (REF SB-R0101, 5 mL/bottle)
- One package insert (instruction for use)
| CATALOG # | PRODUCT | QUANTITY | SPECIMEN |
R0101C |
Leptospira IgG/IgM Combo Rapid Test |
30/kit |
S, P & WB |
LH FIA Test
Features:
- Quantitative, non-subjective results
- Increased sensitivity and broader detection range compared to rapid tests
- Working range: 1.0-200.0 mIU/mL
- Intra-lot Precision Intra-lot precision was determined by testing of LH reference materials using 10 test devices from the same lot. CV ≤ 15%.
- Inter-lot Precision Inter-lot precision was determined by testing of LH reference materials using 30 test devices from 3 consecutive lots randomly (10 test devices from each lot). CV ≤ 20%.
- LH control materials with three different concentrations were tested by every lot of test device, and the deviations were within ±15%.
- A serial concentration of LH reference materials at 1.0-200.0 mIU/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 |
F1090 |
LH FIA Test |
25/kit |
Serum, Plasma |
Malaria Pf/Pan Ag Rapid Test CE
Features:
- Meets WHO acceptance criteria
- Ease of use, requires minimal training of personnel
- Expanded testing facility options including areas where quality microscopy is not available
- Quick turnaround time to results
- Increased cost effectiveness, no high cost equipment monitoring
- Availability of Positivia external controls
- Individually sealed foil pouches containing:
- One cassette device
- One desiccant
- 5 µL Blood transfer devices (sample loops, mini plastic droppers or capillary tubes)
- Blood Lysis buffer (REF SB-R0113, 10 mL/bottle)
- One package insert (instruction for use)
| CATALOG # | PRODUCT | QUANTITY | SPECIMEN |
R0113C |
Malaria Pf/Pan Ag Rapid Test CE |
30/kit |
WB |
Malaria Pf/Pv Ab Combo Rapid Test CE
Features:
- Uses serum, plasma or whole blood specimens
- Utilizes highly purified antigen to ensure test sensitivity and specificity
- Detects total antibodies to Pf and Pv
- Ease of use, requires minimal training of personnel
- Quick turnaround time to results
- Individually sealed foil pouches containing:
- One cassette device
- One desiccant
- Two-mark capillary tubes (10/20 µL)
- Sample diluent (REF SB-R0111, 5 mL/bottle)
- One package insert (instruction for use)
| CATALOG # | PRODUCT | QUANTITY | SPECIMEN |
R0111C |
Malaria Pf/Pv Ab Combo Rapid Test CE |
30/kit |
S, P &WB |
Malaria Pf/Pv Ag Rapid Test CE
Features:
- Meets WHO acceptance criteria
- Ease of use, requires minimal training of personnel
- Expanded testing facility options including areas where quality microscopy is not available
- Quick turnaround time to results
- Increased cost effectiveness, no high cost equipment monitoring
- Availability of Positivia external controls
- Individually sealed foil pouches containing:
- One cassette device
- One desiccant
- 5 µL Blood transfer devices (sample loops, mini plastic droppers or capillary tubes)
- Blood Lysis buffer (REF SB-R0112, 10 mL/bottle )
- One package insert (instruction for use)
| CATALOG # | PRODUCT | QUANTITY | SPECIMEN |
R0112C |
Malaria Pf/Pv Ag Rapid Test CE |
30/kit |
WB |
MAU FIA Test
Features:
- Quantitative, non-subjective results
- Increased sensitivity and broader detection range compared to rapid tests
- Working range: 2.0-300.0 mg/L
- Intra-lot Precision: Intra-lot precision was determined by testing of MAU reference materials using 10 test devices from the same lot. CV ≤ 15%.
- Inter-lot Precision: Inter-lot precision was determined by testing of MAU reference materials using 30 test devices from 3 consecutive lots randomly (10 test devices from each lot). CV ≤ 20%.
- MAU control materials with three different concentrations were tested by every lot of test device, and the deviations were within ±15%.
- A serial concentration of MAU reference materials at 2.0-300.0 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 |
F2020 |
MAU FIA Test |
25/kit |
Urine |
Medica EasyLyte PLUS (Na+/K+/Cl-) Medica EasyLyte Calcium (Na+/K+/Ca++/pH) Medica EasyLyte Expand (Na+/K+/Cl-/Ca++)
MYO FIA Test
Features:
- Quantitative, non-subjective results
- Increased sensitivity and broader detection range compared to rapid tests
- Working range: 2.5-400.0 ng/mL
- Intra-lot Precision Intra-lot precision was determined by testing of MYO reference materials using 10 test devices from the same lot. CV ≤ 15%
- Inter-lot Precision Inter-lot precision was determined by testing of MYO reference materials using 30 test devices from 3 consecutive lots randomly (10 test devices from each lot). CV ≤ 15%.
- MYO control materials with three different concentrations were tested by every lot of test device, and the deviations were within ±15%.
- A serial concentration of MYO reference materials at 20.0-400.0 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 |
F3030 |
MYO FIA Test |
25/kit |
Serum, Plasma |