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 |
Boa-Sorte 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 |
Farzadegan 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 48Â 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 | 2.8Â 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 |
Khan 1996 Pakistan | 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 US | Cross-sectional |  | Temprature: ambient temperatures Time: Not specified | 50 μl on Whatman (8 mm) | ADVIA Centaur 5634 W | ADVIA Centaur 5634 W |  | 100 19/19 | 100 44/44 | r = 0.99 | Samples stored at ambient temperature and assayed for month four months every week with HBsAg concentration stable |
Mendy 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 |
Mohamed 2013 France | Cohort | Broad, 200 | Temperature: Room temperature Time: 1, 3, 7 and 14 days | Venipuncture 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 |
Mossner Denmark 2016 | 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% 84/85 | 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 11/11 | NR | NR |
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 |
Ross 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 |
Villa Italy 1981 | Cross-sectional | Patients attending liver clinic, 24 | Temperature: -20C 4C and room temperature. Time: 1,7, 15, 30, 60, and 180Â 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 15Â days negatively affected sensitivity. |
Villar Brazil 2011 | 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 |
Zhuang Australia 1982 | 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 90/90 | NR | Storage at 4 °C, ambient temperatures and 37 °C up to 1 month did not lower sensitivity |
Zoulek Sao Tome and Principe 1983 | 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 |