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Two minutes to result.
No expensive lab equipment required
Highly specific 3B6 antibody
Over 200 publications worldwide
Can be performed in front of the patient
Helps to screen patients prior to imaging
For sales and technical enquiries relating to SimpliRED D-dimer, please contact us for details of your local distributor:
Tel: +44 (0) 29 2074 7232
Fax: +44 (0) 29 2074 7242
E-mail: simplired@britishbiocell.co.uk
Question 1: What sample types are suitable?
Answer: SimpliRED D-dimer is suitable only for whole blood, this can be from a Sodium Citrate or Lithium Heparin tube, or a finger prick sample. Outside of the USA EDTA samples have also been validated.
Question 2: Can plasma or serum be used?
Answer: No, SimpliRED relies on the agglutination of red blood cells to visualise the reaction.
Question 3. Can samples be remixed and tested after they have been centrifuged?
Answer: As long as no plasma has been removed this is acceptable.
Question 4. What if 100-200 µL (or more) of plasma / serum has been removed?
Answer: The concentration of red blood cells in the sample is important for the correct functioning of the assay, removing plasma from the sample may well cause the agglutination to be more difficult to see, increasing the risk of a false negative result.
Question 5: Can the product be serially diluted for semi-quantitative use?
Answer: No, SimpliRED D-dimer is a qualitative positive/ negative assay with a set cut off.
Question 6: Why does my SimpliRED result differ from results obtained on another manufacturer’s test?
Answer: Different antibodies have different specificities to D-dimer and other fibrin degradation products. This means that at different times in the clot breakdown, different assays will therefore depending on their cut off’s, sensitivities and specificities give different results. SimpliRED has been extensively validated against clinical outcome, the only current way of confirming diagnostic accuracy. It has also been found that the position and size of the clot can cause reduced D-dimer levels although this may also correlate with clinical outcomes.
Question 7: What are the possible reasons for agglutination in the negative control well?
Answer: Firstly check that the negative control has not been contaminated with D-dimer antigen (this could occur if the caps from the positive and negative control have been switched). Either test the negative control against a known D-dimer negative patient or alternatively test the negative control from a fresh kit with the same patient’s blood. If the negative control is still positive then this may be due to the action of an autoantibody in the patient’s blood which is causing auto-agglutination of the patient’s own blood cells, this is generally due to cold agglutinins, and the sample may need to be warmed to 37°C to get a valid result.
Question 8: Does HCT affect the test?
Answer: The whole blood method (35 µL) is specified to give equivalent results within the haematocrit range (0.35 and 0.60).
If HCT falls below 0.35 then more plasma will be delivered within the 35uL whole blood sample applied to the assay. Therefore this will increase the sensitivity and decrease the specificity of the assay.
HCT values above 0.60 result in less plasma delivered in a whole blood sample as compared to a normal HCT (i.e. 0.45) therefore this may slightly decrease the sensitivity of the assay and increase the specificity.
Question 9: What is the CLIA categorisation of this test?
Answer: SimpliRED D-dimer is a CLIA moderate assay.
Question 10: Can I obtain more slides and stirrers?
Answer: Extra slides and stirrers are available from you local distributor.
Please feel free to ask further questions so we can add to this FAQ’s through the ‘contact us’ section.