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Table 1 Characteristics of studies included in the systematic review on HBV surface antigen detection from DBS compared to venous blood sampling

From: Diagnostic accuracy of serological diagnosis of hepatitis C and B using dried blood spot samples (DBS): two systematic reviews and meta-analyses

Author, Year, Country Study design Study pop, Sample size Storage conditions DBS collection method Serum and plasma antigen test DBS antigen test Suggested Cut-off Specificity Sensitivity Correlation/Agreement Effect of storage conditions
Alidjinou 2013 Congo-Brazzaville Cross-sectional Attending hepatology clinic, 32 Temperature: Room temperature (25C) Time: 2 months Whole blood by venipuncture, 30 μl of plasma onto filter paper Enzygnost ELISA (Siemens) Enzygnost ELISA (Siemens) NR 100 100 Spearman correlation coefficient r of 0.89 No significant change
2014 Brazil
Cross-sectional Pregnant women, 692 Temperature: Refrigerated Time: Less than 5 days Unclear amount, venipuncture, Schleicher & Schuell 903© filter paper IMUNOSCREENHBSAG–SS (Mbiolog Diag.), and Murax HB Sag (Murax BioTech Unlmtd.) IMUNOSCREENHBSAG–SS (Mbiolog Diag.), and Murax HB Sag (Murax BioTech Unlmtd.) NR 100 100 NR NR
Brown, 2012, UK Cross sectional Unclear NR NR Abbott Architect I2000 Abbott Architect I2000 NR 100 (unclear N) 98% (unclear N) NR NR
Farghaly AM 1990 Egypt Cross sectional 29 HBsAg pos sera 10 sera positive for anticore only 25 sera negative for any marker of HBV Temperature: Refrigerated (−20 °C) 5 ml by venepuncture, three drops of blood (50-100 μl) on Whatman No.3 Enzygnost HBsAg Enzygnost HBsAg NR 100 (25/25) 100 (29/29) NR NR
1978 Iran
Cross-sectional 10 carriers of HBsAg, 10 NR Capillary (>0.025 ml) Whatman 4 RIA (Austria II, Abbot), Abbot’s Auscell RIA (Austria II, Abbot), Abbot’s Auscell NR NR 100 (10/10) NR Samples stored for 1, 3, 7, 14, and 30 days at 4 °C and 37 °C. Best storage temp °4.
Forbi 2010 Nigeria Cross-sectional Broad, 300 Temperature: 4C Time: Overnight Venipuncture, 25 μl of whole blood, Whatman filter paper Shantest TM- HBsAg ELISA Shantest TM- HBsAg ELISA NR 88.6 78.6 NR NR
Grune 2015 Germany Cross-sectional Inpatients 299 Temperature: −20C, 4C or ambient temperature Time: Up to 14 days Venipuncture, 100 μl whole blood on paper card Not specified Not specified 0.15 IU/ml Derived from different sample 99.8 91.7 NR NR
Halfon 2012 Cohort Broad, 200 Temperature: -20C (within 48 h of collection) Time: Not specified Finger prick, 3 drops whole blood on paper card BV Cobas Taqman (Roche), Abbott Architect BV Cobas Taqman (Roche), Abbott Architect 2.8 IU/mL 100 98 NR NR
Kania 2013 Burkina-Faso Cross-sectional Attendees of HIV testing center, 218 Temperature: Ambient temperature Time: Not specified 5 spots whole blood (50 μl) on Whatman 903 Determine, SD Bioline, ETI-MAK-4 HBsAg EIA (DiaSorin S.p.A.), Architect HBsAg QT (Abbott) Determine, SD Bioline, ETI-MAK-4 HBsAg EIA (DiaSorin S.p.A.), Architect HBsAg QT (Abbott) Optical density: MAPC (mean absorbance of positive control)/2 + 0.3 standard deviations = 0.825. 100 96 Kappa: 0.98 NR
Cross sectional Broad, 90 Temperature: 2–8 °C
Time: overnight
Venepuncture, NR Enzygnost, HBsAg monoclonal II by Behring Enzygnost, HBsAg monoclonal II by Behring Cut off value (according to figures: 0.116 mean absorbance value) 100 (86/86) 100 (4/4) NR NR
Lukacs Germany 2005 Unclear 70 random samples from newborns (as negative controls), 8 hepatitis b patients Temperature: NR
Time: NR
Venipuncture, NR NR Luminex 100 reader, SREPE Cut-off median fluorescence intensity 233 (mean + 2 Standard deviations for healthy controls) NR 100% (8/8) NR NR
Lee 2011 Malaysia Cross-sectional Patients at a tertiary hospital, 150 Temperature: -20C
Time: NR
Venipuncture, 50 μl whole blood on filter paper Abbott, Pearson Test Abbott, Pearson Test Cut-off point of 1.72
Relative light units
98 97 Pearson value, r = 0.43 NR
Mayer 2012
Cross-sectional   Temprature: ambient temperatures
Time: Not specified
50 μl on Whatman (8 mm) ADVIA Centaur 5634 W ADVIA Centaur 5634 W   100
r = 0.99 Samples stored at ambient temperature and assayed for month four months every week with HBsAg concentration stable
2005 The Gambia
Cohort Broad, 166 Temperature: 30-33C (humid conditions)
Time: Up to 4 weeks
Three to five drops of blood (20 μl) on filter paper Determine HBsAg (Abbott Laboratories) Determine HBsAg (Abbott Laboratories)   100 96 NR NR
2013 France
Cohort Broad, 200 Temperature: Room temperature
Time: 1, 3, 7 and 14 days
50 μl on 12 mm discs (Whatman)
Chemiluminescent microparticle immunoassay (Abbott) Chemiluminescent microparticle immunoassay (Abbott) 0.30 +/−0.81 IU/mL. 100 98 r = 0.85 No significant change
Cohort 404 Prospective patients from hepatitis clinic and blood donors Temperature: Room temperature
Time 1–5 days
Finger prick, 75 μ on Whatman filter paper Architect HBs Ab and Architect
HBc Ab assays using the Architect system (Abbott Diagnostics, Delkenheim, Germany)
Architect HBs Ab and Architect
HBc Ab assays using the Architect system (Abbott Diagnostics, Delkenheim, Germany)
The DBS negative patient had serum quantitative level of HbsAg 175 IU/mL. 100% 318/318 98%
NR Variation of 24 h to up to 7 d found no difference in stability of samples
Nielsen, 1980, Germany Cross sectional 110 patients of both sexes older than 6 years attending outpatient department of the General Hospital Barmenda, Cameroon Temperature Venipuncture, 50 μl on 16 mm diameter filter paper, Schleicher-Schüll RIA (Ausria II-test) RIA (Ausria II-test) NR NR 100
Parkinson, 1996, Alaska Cross sectional Alaska Native carriers of HBsAg, volunteer and pregnant females, 10 Temperature and Time NR Venipuncture, 100 μl applied to 1,5 cm diameter filter paper (No 903, Schleicher &Schuell) RIA (Ausria II-test) RIA (Ausria II-test) Limit of detection approximately 1.25 ng/ml in blood spots NR 100 (10/10) NR Detectable after 8 weeks of storage at ambient temperatures
2013 Germany
Cross-sectional Broad, 299 Time and temperature not specified Venipuncture, 100 μl applied to filter paper (Whatman) Abbott ARCHITECT HBsAg Abbott ARCHITECT HBsAg 15 IU/ml (HBsAg) 100 99 r = 0.86, good agreement in Bland-Altmann plot NR
Cross-sectional Patients attending liver clinic, 24 Temperature: -20C 4C and room temperature.
Time: 1,7, 15, 30, 60, and 180 days
Capillary blood on Whatman filter paper Ausria II, Ausab, Corab, e-anti e RIA kit (Abbott) Ausria II, Ausab, Corab, e-anti e RIA kit (Abbott) Unknown 100 100 NR Temperature: Storage at room temperature resulted in no significant change compared to samples stored at 4C or -20C.
Time: Storage greater than 15 days negatively affected sensitivity.
Cross sectional Patients attending HCVlinic, 133 Temperature:-20C, 4–8C, 22–25C, and 22–25C.
Time:1, 7, 14, 21, 42, 63, 112, and 183 days.
either a finger prick or from 70 μl of a whole blood sample onto the 903 Specimen Collection Paper, Whatman Protein Saver Card ETI-MAK-4 (Diasorin) ETI-MAK-4 (Diasorin) Absorbance value 0.115 97 98 NR Accuracy of DBS samples was stable over 63 days at all temperatures evaluated but after 63 days, accuracy diminished when stored at 22–25C
Cross-sectional 90 sera selected from serum collection at Fairfield Hospital, Australia Temperature: incubated at room temperature
Time: 1 night
200 μl on filter-paper (glass-fibre paper, cut into 3x3cm squares) Ausria II-125 RIA NR NR 100
NR Storage at 4 °C, ambient temperatures and 37 °C up to 1 month did not lower sensitivity
Sao Tome and Principe
Cross sectional 86 children (48 boys, 38 girls, mean age: 8,3 + − 8,5) Temperature: stored at 4 °C for 2 weeks, −20 °C for weeks
Time: 2 weeks, then unspecified
Venepuncture 2–4 drops (50-100 μl) on 1 cm filter paper discs RIA Abbot (unspecified) RIA Abbot (unspecified) Lowest concentration analysed 0,1 mg/l NR 100 24/24 NR NR