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Table 2 Characteristics of studies included in the systematic review on HCV antibody 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, Country Study design Study pop, Sample size Storage conditions DBS collection method Serum and plasma antibody test DBS antibody test Suggested Cut-off Specificity Sensitivity Correlation/Agreement Effect of storage conditions
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