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
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 |
H. pylori Ag Rapid Test CE
Features:
- Clinical accuracy: 96.7% sensitivity, 93.8% specificity
- Analytical sensitivity: 100% positive detection rate at 1 ng/mL of pylori lysate antigen in fecal specimens
- Cross reactivity: no cross reactivity with the following organisms at ≥ 1 x 108 org/mL: Acinetobacter calcoaceticus, Neisseria gonorrheae, Adenovirus, Neisseria meningitides, Enterococcus faecalis, Proteus mirabilis, Escherichia coli, Proteus vulgaris Hauser, Gardnerella vaginalis, Pseudomonas aeruginosa, Geotrichum candidum, Rotavirus, Haemophilus influenza, Salmonella Paratyphi A, α-haemolytics streptococcus, Salmonella Paratyphi B, β-haemolytic streptococcus, Salmonella Paratyphi C, Klebsiella pneumonia, Salmonella typhi, Moraxella catarrhalis
- Interference: No interference was seen with 5 mg/mL Tums® Antacid, 1:20 Pepto-Bismol® Antacid, 5 mg/mL Tagamet® Antacid, 5% Barium sulfate, 5 mg/mL Prilosec® Antacid, 12.5% Hemoglobin (tarry stool), or 1:20 Mylanta® Antacid
- Shelf life: 24 month
- 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
- Package insert (instruction for use)
| CATALOG # | PRODUCT | QUANTOTY | SPECIMEN |
R0192C |
H. Pylori Ag Combo Rapid Test CE |
25/kit |
Fecal |
hCG Combo Rapid Test (strip) 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 99.5% 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
-
Kit box package:
1. Individually sealed foil pouches containing;
a. One dip strip device
b. One desiccant
2. One package insert (instruction for use)
Tube package:
1. Strip Package
2. One desiccant
3. One package insert (instruction for use)
| CATALOG # | PRODUCT | QUANTITY | SPECIMEN |
R1001S |
hCG Combo Rapid Test(strip) CE |
50/kit,100/kit |
S/Urine |
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 |
HSV-1 IgG/IgM Rapid Test CE
Features:
-
- Type-specific detection by utilizing glycoprotein G1.
- Single test that detects and differentiates IgG and IgM anti-HSV-1.
- High confidence as test is in agreement with market leading ELISA test: 90.7% IgG; 85.0% IgM.
- Flexible specimen types including serum, plasma, or whole blood which allows testing at any time without special specimen preparation.
- Small sample volume (10 µL) enables multiple testing on the same specimen without having to re-draw the patient.
- Initial treatment action can begin during the patient’s visit as test results are available in 10 minutes.
- Easily transported, and can be stored for 24 months, 2-30oC.
- Individually 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 | QUANTITY | SPECIMEN |
R0203C |
HSV-1 IgG/IgM Rapid Test CE |
30/kit |
S,P& WB |
HSV-2 IgG/IgM Rapid Test CE
Features:
- Unique test that utilizes glycoprotein G2 to differentiate between HSV-1. and HSV-2 that allows for an early start of treatment action.
- Immediate determination of either acute or chronic infection by detecting and differentiating IgG and IgM anti-HSV-2.
- High confidence as test is in agreement with market leading European ELISA: 95.3% IgG; 100% IgM.
- Flexible specimen types including serum, plasma, or whole blood which allows testing at any time without special specimen preparation.
- Small sample volume (10 µL) enables multiple testing on the same specimen without having to re-draw the patient.
- Initial treatment action can begin during patient’s visit as test results are available in 10 minutes.
- Easily transported, and can be stored for 24 months, 2-30oC.
- Individually sealed foil pouches containing:
- One cassette device
- One desiccant
- Capillary tubes (10 µL)
- Sample diluent (REF SB-R0213, 5 mL/bottle)
- Package insert (instruction for use)
| CATALOG # | PRODUCT | QUANTITY | SPECIMEN |
R0213C |
HSV-2 IgG/IgM Rapid Test CE |
30/kit |
S,P& WB |
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 |