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QuikRead go iFOBT

QuikRead go iFOBT is an immunochemical FIT test for detection and quantification of human haemoglobin in faeces in case of suspected bleeding from the lower gastrointestinal tract. The measurement is carried out with the QuikRead go instrument which can be connected to HIS/LIS systems, if needed.

Generally
Technical data
About the analyte and testing
Additionally needed materials
Documents and materials

Generally

This ready-to-use kit and its straightforward test procedure together with the instrument provide an accurate result in less than three minutes.

The results can be obtained as qualitative or as quantitative, numerical results.

When used as a qualitative test the samples containing human haemoglobin above 15 µg/g faeces (75 ng/ml) are recognized as positives.

The quantitative measurement range starts from 10 µg/g faeces (50 ng/ml) and concentrations up to 200 µg/g faeces (1000 ng/ml) are shown as numerical result. Concentrations above this are displayed as > 200 µg/g (>1000 ng/ml).

QuikRead go iFOBT provides you with

Adaptiveness

Quantitative results enable use of national recommendations
Results can be weighed against each patient's age and gender or possible risk factors
Flexible test procedure is easy to fit into the daily routines of laboratories and in point-of-care
Five (5) days sample stability in the sampling vial at 18-25°C allows convenient sampling at home and time to return the sample to the analyzing site

Objectiveness

Numerical results in range of 10-200 µg/g (50-1000 ng/ml)
Instrument settings allow choosing a qualitative result with a cut-off of 15 µg/g
Instrument read results make visual result interpretation unnecessary

Reliability

Automated test procedure includes only few manual steps
Handy and hygienic sampling vial regulates the quantity of the sample

Proven QuikRead quality

No need for manual calibration of the test
Results are automatically stored in the instrument’s memory
User and patient information can be stored with the results and sent to LIS/HIS when required
Connectivity and bi-directional data exchange allow to manage several instruments centrally

Test results should never be used alone, without a complete clinical evaluation.

QuikRead go iFOBT is not registered in the USA.

Technical data

Products available	151051 QuikRead go iFOBT, 50 tests
Use	For in vitro diagnostic use
Method	Immunoturbidimetric
Sample type	Faeces
Instrument information	QuikRead go Instrument
Time to result	Less than 3 minutes
Reading of the result	Instrument read
Storage	2 - 8 °C
Shelf life	14 months
Transportation	2 - 8 °C
Size and weight	10 x 14 x 8 cm, 452 g
Full export carton of kits	24
Additionally needed	With QuikRead go iFOBT 151051 QuikRead go Instrument 133893 QuikRead iFOB Sampling Set (50 sampling tubes) 151052 QuikRead FOB Positive Control 06027 QuikRead go iFOBT Control Quantitative 152390 With QuikRead go iFOBT 136189 QuikRead go Instrument 133893 QuikRead FOB Sampling Set 138822 QuikRead FOB Positive Control 06027 QuikRead FOB Control Quantitative 144675
Country of origin	Finland
Registration	Not registered in the USA
Registered trademark	QuikRead go is a registered trademark of Aidian Oy

About the analyte and testing

The normal physiological bleeding from the gastrointestinal tract is low in healthy persons. The faecal haemoglobin varies with gender and age, being higher for males than females and increasing by age for both genders.

Occult gastrointestinal bleeding is defined as bleeding which is unknown to the patient. Occult bleeding itself is not a disease, but it might be a symptom of various conditions.

Significant amounts of blood can be hidden in faeces. Faecal occult blood tests provide information on excessive bleeding and mandate further investigations of the gastrointestinal tract, starting typically with the colon.

Additionally needed materials

QuikRead iFOB Sampling Set and QuikRead FOB Sampling Set contains 50 sampling tubes with buffer, instructions for use, patient labels and patient instructions. These tubes are designed to collect the defined faeces amount into the buffer and to dispense the correct volume of sample solution into the test cuvette. The sampling tubes are intended for use with QuikRead go iFOBT or QuikRead FOB quantitative tests.

QuikRead FOB Positive Control is intended for high concentration quality control of QuikRead FOB quantitative and QuikRead go iFOBT assays. If the qualitative measurement is in use, the result should be “Positive” and when the test is used as quantitative, the result should be > 1000 ng/ml or > 200 µg/g

QuikRead go iFOBT Control Quantitative and QuikRead FOB Control Quantitative kits are intended for low concentration quality control of QuikRead FOB quantitative or QuikRead go iFOBT assays. The control should provide a “Positive” result when the qualitative measurement is used and when the quantitative measurement is used, the result should be within the range indicated on the control vial label.