Table 2 Characteristics of studies included in the systematic review on HCV antibody detection from DBS compared to venous blood sampling

Brandao

Brazil 2013

Cross sectional

386 persons, 40 anti-HCV pos, 346 blood donoers HCV non-reactive,

DBS samples air dried at room temperature for 4 h, stored at −20 °C.

Temperature: −20 °C

Time: Not specified

capillary blood by finger prick 75 μl onto Whatman filter paper

MonolisaTM HCV AgAb ULTRA, Bio-Rad (Marnes-la-Coquette, France), and Murex HCV AgAb, Abbott (Kyalami, Republic of South Africa).

MonolisaTM HCV

AgAb ULTRA, Bio-Rad (Marnes-la-Coquette, France), and Murex

HCV AgAb, Abbott (Kyalami, Republic of South Africa).

ROC cutoff: 0.287 nm for Monolisa assay

ROC cut-off for Murex assay 0.238 nm

Derived from the same sample

99.7 (98.4–99.9)

95.9 (93.3–97.8)

97.5 (86.8–99.9)

97.5 (86.8–99.9)

PPV and NPV calculated

Kappa = 0.99 (with ROC cut-off),

stability up to 60 days of storage at room temperature, but less variation at −20 °C

Croom Australia 2006

Cross sectional

103 samples from high risk groups, negative samples from 94 indivdiuals tested at Haematology Lab

Air dried at room temperature, storage at −20 °C, plasma at −20 °C, time of storage 1 week −11 months

Temperature: −20 °C

Time: 1 week −11 months

Venipuncture, 80 μl of each whole blood sample spotted onto Schleicher and Schuell cards (Grade 903)

Monolisa EIA, confirmation test: Murex anti HCV (version 4.0), EIA

Monolisa EIA, confirmation test: Murex anti HCV (version 4.0), EIA

NR

100% (96–100)

108/108

100% (94–100)

75/75

NR

NR

Chevaliez

France 2014

Unclear

529 patients, 183 HCV seronegative, 346 seropositive

NR

NR

EIA HCV assay

EIA HCV assay

0.2

98.9 (96.1–99.7)

99.1 (97.4–99.7)

R = 0.56

NR

Dokubo

US 2014

Cross sectional within a prospective cohort study of those HCV positive being followed

148 participants in a prospective study of HCV

DBS air-dried for 2 h, then sent to another insitute, then stored at −70 °C

Fingerstick on Whatman 903 cards 0.5 ml blood

Standard diagnostics HCV TMA (Norvatis®)

ELISA v3.0(Ortho®).

Standard diagnostics HCV TMA (Norvatis®)

ELISA v3.0(Ortho®).

100%

(71/71)

70%

(54/77)

Kappa 0.69

NR

Flores

2016

Brazil

Cross sectional

Participants recruited from ambulatory and general hospital, known HCV/HIV serological status

DBS airdried 4 h, then frozen at -20C

Venipuncture, Whatman filter paper, 3–5 drops (~75 μl)

HCV Murex AB, Diasorin

HCV Murex AB, Diasorin

NR

100%

(99/99)

94%

(213/230)

Spearman correlation r = 0.520

NR

Gruner

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

Derived from different sample

NR

99%

339/343

NR

NR

Kania Burkina-Faso 2013

Cross sectional

218 HIV screening participants, 5 anti-HCV pos, 213 anti-HCV neg

NR

Venipuncture, 5 spots whole blood (50 μl) on Whatman 903

Monolisa HCV-Ab-Ag ULTRA assay (Bio-Rad), further assessment with Inno-Lia HCV Score assay (Innogenetics)

Monolisa HCV-Ab-Ag ULTRA assay (Bio-Rad), further assessment with Inno-Lia HCV Score assay (Innogenetics)

0.439

100% (97,8–100%)

100% (46,3–100%)

kappa: 1,00 (0,93–1,00)

NR

Larrat

France 2012

Cross sectional

One hundred thirteen HCV-positive cases consecutively

recruited 17 HIV/HCV co-infected patients (15%)

DSB dried 24 h at room temperature

Finger prick blood on Whatman card

Monolisa® HCV-Ag-Ab-ULTRA,

Bio-Rad)

Oraquick HCV

CEIA Biorad

0.1

0.2 cEIA

100 (95.8–100) 88/88

100 (95.8–100)

88/88

97.4(92.5–99.1) 110/113

98.2 (93.8–99.5)

111/113

ROC AUC OMT cEIA Biorad: 0.99

ROC AUC FSB cEIA Biorad: 0.918

At 3 days room temperature 3/3 HCV negative samples NR,

ODs lower in HIV co-infected patients

Lee Malaysia 2011

Cross sectional

150 paired samples

Left to dry overnight at room temperature, then stored −20 °C

Venipuncture, 50 μl whole blood on filter paper

Abbott

Abbott

ROC cut off 0.10 RLU

100%

97.3%

ROC curve AUC: 0.99

R = 0.631

NR

Lukacs Germany 2005

Unclear

7 samples from known HCV patients

NR

NR

NR

Luminex

NR

NR

100% 7/7

NR

NR

McCarron

UK 1999

Case control

NR

NR

NR

NR

NR

0.99

1.99

87.5%

100%

100%

97.2%

NR

NR

Marques

Brazil 2012

Cross sectional

21 and 24 HCV reactive patients,

234 individual

and 132 HCV negative

serum stored at −20 °C

Venipuncture, 75 μl whole blood on Whatman paper

Two methods: HCV-Ab Radim, Pomezzia, Italy and ETI-AB-HCVK-4 DiaSorin, Vercelli, Italy

Two methods: HCV-Ab Radim, Pomezzia, Italy and ETI-AB-HCVK-4 DiaSorin, Vercelli, Italy

Radim: manu-facturer’s cut off

ROC curve for DiaSorin EIA using the same sample population

99.5% (98–99.9)

98.9% (96.80–99.55)

97.5%

(86.84–99.94)

88.9% (75.95–96.29)

NR

2–8 degrees C, 20–25 degrees C, and −20 degrees were evaluated, −20 resulted in lowest variation Methods of cut off determination: the receiver operating characteristic curve(AUROC)

Marques

Brazil 2016

Recruited at Viral Hepatitis Lab

99 (59 anti HCV/HCV RNA pos, 40 neg samples)

NR

Venipuncture, 3–5 drops on Whatman filter paper

HCV Ab Radim, Pomezia, Italy

HCV Ab Radim, Pomezia, Italy

100%

40/40

94.9%

56/59

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 HCV

Ab, using the Architect system (Abbott Diagnostics, Delkenheim, Germany)

Architect HCV

Ab, using the Architect system (Abbott Diagnostics, Delkenheim, Germany)

NR

100%

288/288

97%

112/116

NR

Variation of 24 h to up to 7 d found no difference in stability of samples

Nandagopal India 2014

Unclear

Murex

60 samples

Venipuncture,50 μl of whole blood 903 Whatman card

NR

NR

NR

100 (29/29)

100 (31/31)

Pearson correlation coefficient 0.98

NR

O Brien

US 2001

Multicenter prospective trial (one-arm only)

1286 subjects enrolled in multi-centre study,

Air dry for 30 min, sent in FedEx envelope

Self collected capillary blood with at home kit

NR

HCV Check, Home Access Corp. self use DBS home kit

NR

Several inconclusive and indeterminate results not included in diagnostic accuracy calculations

100%

686/686

99.5% 402/404

NR

NR

Parker

UK 1997

Case control design

80 anti HCV positive samples, 52 negative

569 dB sample fields from South African neonates

Air dry at room temperature before storage at 4 °C

NR, Dried blood field samples

In house IgG ELISA, immunoblot RIBA 3.0

In house IgG ELISA, immunoblot RIBA 3.0

T/N 5.0

T/N10.0

541/569 95.1%

78/80 98%

69/80

86.2%

NR

Ross

Germany 2013

Unclear

339 samples

Dried overnight at room temperature

Venipuncture

100 μl of whole blood applied to Whatman 903 filter paper

ARCHITECT

system (Abbott Diagnostics, Delkenheim, Germany).

ARCHITECT

system (Abbott Diagnostics, Delkenheim, Germany).

NR

100% (97.7–100)

160/160

97.8%

(96–100)

175/179

NR

NR

Soulier

France

2017

Cross-sectional

511 patients recruited, with known serostatus for HCV

Temperature:-80

Time: NR

Venipuncture, 50 μl on Whatman filter paper

EIA; aHCV Vitros ECi; Diagnostics, Raritan, New Jersey).

EIA; aHCV Vitros ECi; Ortho-Clinical Diagnostics, Raritan, New Jersey).

NR

312/315

98%

183/186

99%

NR

25 dB samples stored at ambient temperatures (24 °C) for a mean duration (±SD) of 19 ± 1 months

Sensitivity for genotype detection in DBS 84.5%

Sheperd

UK 2013

Cross sectional

19 recently infected

300 chronic carrier

82 resolved infection

DBS stored at 4 °C until use

NR, 50 μl on 903 Whatman Protein Saver cards

ORTHO HCV 3.0 ELISA Test System with Enhanced SAVekit (Ortho Clinical Diagnostics) was used to detect anti-HCV in DBS

NR

Avidity cut-off AI < 30

NR

NR

NR

NR

Tejada-Strop

US 2015

Case control

103 patients with known HCV result, 33 adult patients with chronic HepC with stored samples

-20 °C until 5 years later

NR, 75 μl of whole blood on 12 mm DBS

Two immunoassays, the VITROS anti-HCV IgG chemi-luminescence assay (CIA) and the HCV 3.0 enzyme immunoassay(EIA), both from Ortho Clinical Diagnostics (Rochester, NY),

Two immunoassays, the VITROS anti-HCV IgG chemi-luminescence assay (CIA) and the HCV 3.0 enzyme immunoassay(EIA), both from Ortho Clinical Diagnostics (Rochester, NY),

3.26 CIA

1.5 EIA

Derived in the same sample

Not calculated

CIA 48/52 92%

EIA 90% 47/52

For stored samples CIA: 100% (33/33)

EIA: 32/33 97%

100% (CIA and EIA)

NR

Tuaillon

France 2010

Case control

100 anti HCV pos serum samples and 100 anti HCV neg samples

18 h dried at room temperature, stored at −20°c for 1–8 weeks

NR, 50 μl of whole blood on Whatman 12 mm paper discs

Ortho HCV 3.0 ELISA, immunoblot assay INNO-LIA HCV Score as confirmatory test

Ortho HCV 3.0 ELISA, immunoblot assay INNO-LIA HCV Score as confirmatory test

Threshold value 0.380

98% (97–100)

99% 97–99)

NR

Stability of anti HCV and HCV RNA investigated by varying room temperature exposure 2–12 days until freezing, after 6 days at room temperature ODs > than cut off values

Waterboer

Mongolia 2011

Cross sectional

1022 sexually active women from cross sectional study (response rate 69%)

Room temperature up to 8 h, then −20 °C up to 1 month (serum + DBS)

Venipuncture, Whole blood applied to 5 spots on DBS filter paper cards (Whatman 903)

In house, the

HCV (strain H77, subtype 1a) Core and NS3 proteins

In house, the HCV (strain H77, subtype 1a) Core and NS3 proteins

Sera 1492 (Core)

371 (NS3)

DBS

967 (Core)

310 (NS3)

Not calculable from the data

Not calculable from the data

98% Agreement (kappa 0.94) for Core

96.1% Agreement (kappa 0.90) for NS3

NR