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QuikRead go iFOBT

QuikRead go iFOBT is an immunochemical 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

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 15 µg/g faeces (75 ng/ml)  and concentrations up to 200 µg/g faeces (75 - 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 15-200 µg/g (75-1000 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
Use For in vitro diagnostic use
Method

immunoturbidimetric

Sample type Faeces
Instrument information

QuikRead go Instrument 133893

Time to result Less than 3 minutes
Reading of the result Instrument read
Storage 2 - 8 °C
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
Registration Not registered in the USA
Registered trademark QuikRead go is a registered trademark of Orion Diagnostica Oy.

About the analyte

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.

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.

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 and patient instructions. These tubes are designed to dispense the correct amount of faeces into the test buffer and 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. The control should provide a positive result when qualitative measurement is used and for quantitative measurement a result of  > 1000 ng/ml or > 200 µg/g.

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

Documents and materials

Marketing and sales materials

QuikRead go iFOBT Sales Sheet (EN)

QuikRead go iFOBT Brief Instruction (EN)

QuikRead go Products Sales Sheet (EN)

QuikRead go Family Brochure (EN)

QuikRead FOB Sampling Set Instruction (EN)

QuikRead go iFOB & FOB Sampler Guide (EN)

Immunochemical Faecal Occult Blood tests (EN)

QuikRead go iFOB Sampling set ePoster Labquality Days 2018 (EN)

Stories

Immunochemical Faecal Occult Blood tests

Videos

QuikRead go iFOBT Test Procedure Video (EN)

 

Video on YouTube: QuikRead go iFOBT Test Procedure

Instructions for use

(For informative use only. Kindly always refer to the latest package insert in the kit.)

QuikRead go iFOBT IFU (GB, DE, FR, NL) 136189

QuikRead go iFOBT IFU (FI, SE, NO, DK) 136189

QuikRead go iFOBT IFU (CZ, SK, ES, EE) 136189

QuikRead go iFOBT IFU (GB, DE, FR, EE) 151051

QuikRead go iFOBT IFU (FI, SE, NO, DK) 151051

QuikRead go iFOBT IFU (CZ, SK, ES, NL) 151051

QuikRead iFOB Sampling Set IFU (GB, DE, FR, NL, ES, EE, CZ, PL, SI, SE, NO, FI, DK) 151052

QuikRead iFOB Sampling Set Patient IFU, 151052

QuikRead FOB Sampling Set IFU (GB, DE, FR, NL, ES, IT, CZ, SK, HU, PL, SI, SE, NO, DK, FI), 138822

QuikRead FOB Sampling Set Patient IFU, 138822

QuikRead FOB Positive Control IFU (GB, DE, FR, NL, ES, IT, CZ, SK, HU, PL, SI, SE, NO, DK, FI), 06027

QuikRead FOB Control Quantitative (GB, DE, FR, NL, ES, IT, CZ, SK, SI, HU, PL, SE, NO, DK, FI), 144675

QuikRead go iFOBT Control Quantitative (GB, FR, DE, NL, ES, IT, SK, CZ, EE, SI, PL, SE, DK, NO, FI), 152390

Safety Data Sheet

QuikRead go iFOBT 136189, 151051 SDS (EN)

QuikRead iFOB Sampling Set 151052 SDS (EN)

QuikRead FOB Sampling Set 138822 SDS (EN)

 

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