clinical validation of 5 novel poc d ... - star-shl innovatie · % false negative 1.4 1.9 1.4 2.3...
TRANSCRIPT
Methods • Patients with a suspicion upon DVT or PE were included by the primary care
physician. • All patients underwent venous puncture before imaging or initiation of
anticoagulants.
• Citrated plasma was collected to measure D-dimer, both with our laboratory reference assay (STA-R Max) and with 5 POC assays (see Table 1).
• Passing-Bablok regression was used to assess the analytical relationship between
D-dimer POC test and reference assays.
• Sensitivity and specificity were calculated using all information from diagnostic VTE imaging.
JS Heerink [email protected] March 21-22 2019
Conclusion
“In our study, next-generation POC D-dimer assays appear to be safe and efficient comparable with the reference STA-R Max routine lab assay”
• In our opinion, other factors should be decisive in selecting a POCT assay, such as: usability; availability of co-tests (i.e., CRP, procalcitonin); pricing (device, reagents). Future studies are necessary to confirm these findings in capillary (whole) blood samples, and a higher number of subjects is needed to determine the cut-off values of the assays.
STA-R Max D-dimer (ng/mL)
PO
CT
assa
y (S
tan
dar
d F
20
0)
D-d
ime
r (n
g/m
L)
STA-R Max
Nano- checker 710 AFIAS-1 i-Chroma II
Standard F200
HIPRO AFS/1
Sensitivity 0.9 0.9 0.9 0.9 1.0 0.9
Specificity 0.6 0.8 0.8 0.8 0.6 0,6
% False negative 1.4 1.9 1.4 2.3 0.9 1.8
Efficiency % Correct
% Non-referrals 67 51
78 63
78 62
79 65
67 50
62 47
Introduction • Symptoms for suspicion of VTE such as dyspnoe or calf
tenderness are very common and not specific for VTE. • It is undesirable to refer the majority of patients to a
hospital, but on the other hand, VTE should not be overlooked. With a Clinical Decision Rule and a D-dimer test, VTE can be ruled out safely in primary care in half of the patients (see figure 1)1,2,3.
• Since no gold Standard for D-dimer testing is available, we assessed how D-dimer results of 5 novel POC assays and a routine laboratory assay related to the diagnosis DVT or PE.
Figure 2: Passing-Bablok
Figure 1: NHG guideline DVT and PE
Key references 1. Baaten et al. NHG Guideline DVT and pulmonary embolism (first revision) Huisarts Wet
2015;58:26-35. 2. Buller HR et al. Safely ruling out deep venous thrombosis in primary care. Ann Int Med.
2009; 150:229-235. 3. Geersing GJ et al. Safe exclusion of pulmonary embolism using the Wells rule and qualitative
D-dimer testing in primary care. BMJ. 2012; 345:e6564.
Results
Table 1: Sensitivity and specificity of D-dimer assays succeeding a low CDR score Abbreviation CDR DVT PE POC VTE
Periphrasis Clinical decision rule Deep Venous Thrombosis Pulmonary Embolism Point of care Venous Trombo-Embolism
Sensitivity Specificity % Correct % Non-Referrals
TP/TP+FN TN/TN+FP TP+TN/total TN+FN/total
TN FN TP FP
# of true negatives # of false negatives # of true positives # of false positives
Graph represents correlation between a POC assay and our routine assay STA-R Max. Identity Passing & Bablok fit (84.97 + 0.93x)
Nanochecker 710 AFIAS-1 i-Chroma II Standard F200 HIPRO AFS/1
Clinical validation of 5 novel POC D-dimer assays for ruling-out Venous Thrombo-Embolism in primary care: “Are they safe and comparable with routine laboratory tests?”
JS Heerink1, R Oudega2, EFA Gemen1, RM Hopstaken3, G-J Geersing2, R Kusters1,4
1Laboratory of Clinical Chemistry and Hematology, Jeroen Bosch Hospital, ’s-Hertogenbosch, 2Julius Centre, University Medical Centre Utrecht, The Netherlands, 3Star-SHL diagnostic centers, Etten-Leur, The Netherlands, 4Department of Health Technology and Service Research, Med Tech Centre, University of Twente, The Netherlands