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QuikRead FOB quantitative

QuikRead FOB quantitative is an immunological quantitative test for detecting occult blood in human stool samples in cases of suspected bleeding from the lower gastrointestinal tract. The kit is used together with a small instrument, the QuikRead 101. The instrument can be connected to HIS/LIS systems if needed.

Generally

The presence of faecal occult blood (FOB) is a sign of many gastrointestinal disorders1. The QuikRead FOB quantitative test helps to identify which patients should undergo additional testing and enables early detection of a potentially fatal disease. This ready-to-use kit with a straightforward test procedure provides an accurate result in less than two minutes.

The QuikRead FOB quantitative test provides you with

Reliability

  • Reproducible quantitative FOB results within a range of 100 - 1000 ng/ml
  • The instrument provides objective reading

Fast results

  • Results are available within minutes

Ease of use

  • Simple test procedure requires no special training
  • Built-in calibration
  • Convenient sampling at home. Sample tubes may also be returned by mail

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

QuikRead FOB quantitative is not registered in the USA. 

Technical data

Products available
Use For in vitro diagnostic use
Method

Immunoturbidimetric

Sample type Faeces
Instrument information

QuikRead 101

Time to result Less than 2 minutes
Reading of the result Instrument read
Storage 2 - 8 °C
Additionally needed
  • QuikRead 101 Instrument 06078
  • QuikRead FOB Sampling set 138822
  • QuikRead FOB Positive Control 06027
Registration Not registered in the USA
Registered trademark QuikRead is a registered trademark of Orion Diagnostica Oy.

About faecal occult blood (FOB)

Intestinal physiological bleeding is considered to be within 0.5 - 1.0 ml per day and, in such cases, the FOB test shows a negative result.

If the bleeding is higher and the FOB test shows a positive result, a more thorough investigation - usually a colonoscopy - is required in order to clarify the origin of the bleeding. To compare the quantitative FOB results, the sample dilution must be standardised. The QuikRead FOB sampling tube regulates the amount of stool sample (10 mg) in 2 ml of buffer resulting in a 1:200 dilution.

The immunological, latex-enhanced method reacts only with human globin, thus eliminating the need for dietary restrictions prior to sampling.

The European Group on Tumor Markers (EGTM) recommends the use of quantitative, immunological FOB testing which enables the cut-off value to be set by the clinician.

The American Gastroenterological Association recommends that persons at average risk (asymptomatic, age > 50 years, no other risk factors) should be tested for FOB annually.1 Pharmaceuticals causing gastrointestinal irritation, such as nonsteroidal anti-inflammatory drugs, should be avoided during the test period since they may cause bleeding.1 This may lead to unnecessary further tests.

Immunological FOB tests (iFOBT) have enabled a significant improvement in analytical specificity.2

References

1.  Winawer SJ, Fletcher RH, Miller L, Godlee F, Stolar MH, Mulrow CD, Woolf SH, Glick SN, Ganiats TG, Bond JH, Rosen L, Zapka JG, Olsen SJ, Gardello FM, Sisk JE, van Antwerp R, Brown-Davies C, Marciniak DA, Mayer RJ: Colorectal cancer screening: Guidelines and rationale; Gastroenterology 1997; 112: 594 - 642.

2. European Guidelines for Quality Assurance in Colorectal Cancer Screening and Diagnosis, European Union 2010.

Documents and materials

QuikRead FOB quantitative Prefilled Cuvettes Data Sheet (GB)

QuikRead FOB quantitative Prefilled Cuvettes Brief Instructions (GB)

QuikRead 101 eLearning (GB)

QuikRead FOB Sampling Set Instruction (GB)

Instructions for use

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

QuikRead FOB quantitative Prefilled Cuvettes IFU (GB, DE, FR, IT), 138820

QuikRead FOB quantitative Prefilled Cuvettes IFU (FI, SE, NO, DK), 138820

QuikRead FOB quantitative Prefilled Cuvettes IFU (NL, ES, SI, GB), 138820

QuikRead FOB quantitative Prefilled Cuvettes IFU (CZ, SK, PL, HU), 138820

QuikRead FOB Sampling Set IFU (GB, DE, FR, RU, 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, RU, 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

Safety Data Sheet

QuikRead FOB quantitative SDS (GB)

QuikRead FOB Sampling Set SDS (GB)

QuikRead FOB Positive Control SDS (GB)

QuikRead FOB Control Quantitative SDS (GB)

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