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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

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 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

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 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.

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