Background
Methods
Search strategy and selection criteria
Screening and data extraction
Risk of bias and quality assessment
Statistical data analysis
Results
Included studies
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 |
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 |
Assessment of study quality and risk of bias (Tables 3 & 4)
Author | Patient selection | Bias | Index test | Bias | Reference standard | Bias | Flow and timing | Bias |
---|---|---|---|---|---|---|---|---|
Was a case control design avoided? Consecutive or random sample of patients? Inappropriate exclusions? | Blinded to reference standard Could the conduct or interpretation of the index test have introduced bias? | Blinded to index? Could the reference standard have introduced bias? | There is an appropriate interval between the index test and reference standard? All patients receive the same reference standard and are included in the analysis? | |||||
Alidjinou | NR, but no case control design | UR | Not blinded, interpretation unbiased | LR | Not blinded, interpretation unbiased | LR | NR | UR |
Boa-Sorte | No case control design, consecutive recruitment | LR | blinded | LR | blinded | LR | Same reference standard, all patients included in analysis | LR |
Brown | Not reported | UR | Not reported | UR | Not reported | UR | Not reported | UR |
Farzadegan | Only cases, no consecutive sampling | HR | Not blinded, interpretation unbiased | LR | Not blinded, interpretation unbiased | LR | NR | UR |
Farghaly | Case control design | HR | Not blinded, interpretation unbiased | LR | Not blinded, interpretation unbiased | LR | NR | UR |
Forbi | No case control design | LR | Not blinded, interpretation unbiased | UR | Not blinded, interpretation unbiased | UR | Sampling not reported, same reference standard | UR |
Gruner | NR | UR | Not blinded, NR | UR | NR | UR | NR | UR |
Halfon | NR, probably case control design | UR | Not blinded, NR | UR | Not blinded, NR | UR | NR | UR |
Kania | Consecutive recruitment | LR | Not blinded, interpretation unbiased | UR | Not blinded, interpretation unbiased | UR | Sampling reported | LR |
Khan | No case control design | LR | Not reported, unclear whether blinded | UR | Not reported, unclear whether blinded | UR | Sampling not reported | UR |
Lee | Consecutive recruitment | LR | Not blinded, interpretation unbiased | LR | Not blinded, interpretation unbiased | LR | Sampling reported, same reference standard | LR |
Lukacs | Case control design | HR | Not blinded, interpretation unbiased | LR | Not blinded, interpretation unbiased | LR | Sampling not reported, same reference standard | UR |
Mayer | NR, probably case control | UR | Not reported, interpretation unbiased | LR | Not reported, interpretation unbiased | LR | Sampling not reported | UR |
Mendy | Case control design | HR | Not blinded, interpretation unbiased | LR | Not blinded, interpretation unbiased | LR | Sampling reported | LR |
Mohamed | Case control design | HR | Not blinded, interpretation unbiased | LR | Not blinded, interpretation unbiased | LR | NR | UR |
Mossner | Sampling from high-risk and low risk groups | HR | Not blinded, interpretation unbiased | UR | Not blinded, interpretation unbiased | UR | Sampling reported, same reference standard, all patients included in analysis | LR |
Nielsen | Only cases | HR | Not reported | UR | Not reported | UR | Sampling not reported | UR |
Parkinson | Only cases | HR | Not blinded, interpretation unbiased | LR | Not blinded, interpretation unbiased | LR | Sampling not reported, same reference standard | UR |
Ross | Sampling not reported, probable case control design | HR | Not blinded, interpretation unbiased | LR | Not blinded, interpretation unbiased | LR | Flow reported | LR |
Villa | Case control design | HR | NR | UR | NR | UR | NR | UR |
Villar | Case control design | HR | Bias possible, as selective samples by OD values | HR | Not blinded, interpretation unbiased | LR | Sampling reported | LR |
Zhuang | No case control design | LR | Not blinded, interpretation unbiased | LR | Not blinded, interpretation unbiased | LR | Sampling not reported | UR |
Zoulek | Unclear, but no case control design, probably random or successive | LR | Not blinded, interpretation unbiased | LR | Not blinded, interpretation unbiased | LR | Sampling not reported, same reference standard | LR |
Patient selection | Bias | Index test | Bias | Reference standard | Bias | Flow | Bias | |
---|---|---|---|---|---|---|---|---|
Was a case control design avoided? Consecutive or random sample of patients? Inappropriate exclusions? | Blinded to reference standard Could the conduct or interpretation of the index test have introduced bias? | Blinded to index? Could the reference standard have introduced bias? | There is an appropriate interval between the index test and reference standard? All patients receive the same reference standard? All patients recruited into the study are included in the analysis? | |||||
Brandao | No case control design, consecutive sample, no exclusions | LR | Not blinded, interpretation unbiased | LR | Not blinded, interpretation unbiased | LR | Sampling reported, same reference standard | LR |
Croom | Sampling from high-risk and low risk groups | UR | Not blinded, interpretation unbiased | LR | Not blinded, interpretation unbiased | LR | All patients included, same reference standard | LR |
Chevaliez | NR | UR | NR | UR | NR | UR | NR | UR |
Dokubo | No case control, concurrent sampling from a prospective cohort | LR | Not blinded, interpretation unbiased | LR | Not blinded, interpretation unbiased | LR | Sampling reported, same reference standard, all patients recruited included in analysis | LR |
Flores | Case control design | HR | Not blinded, interpretation unbiased | LR | Not blinded, interpretation unbiased | LR | Sampling reported, same reference standard, all patients recruited included in analysis | LR |
Gruner | NR | UR | Not blinded, NR | UR | NR | UR | NR | UR |
Kania | Consecutive recruitment | LR | Not blinded, interpretation unbiased | LR | Not blinded, interpretation unbiased | LR | Sampling reported | LR |
Larrat | Consecutive recruitment, but of known cases and known negative controls | HR | blinded | LR | Blinded | LR | Sampling reported, same reference standard | LR |
Lee | Consecutive recruitment | LR | Not blinded, interpretation unbiased | LR | Not blinded, interpretation unbiased | LR | Sampling reported, same reference standard | LR |
Lukacs | NR | UR | NR | UR | NR | UR | Sampling reported, same reference standard | LR |
McCarron | Case control, known positive and negative cases from prevalence survey | HR | NR | UR | NR | UR | NR | UR |
Marques 2012 | No case control design | LR | Not blinded, interpretation unbiased | LR | Not blinded, interpretation unbiased | LR | Sampling reported, same reference standard | LR |
Marques 2016 | NR | UR | Not blinded, interpretation unbiased | UR | Not blinded, interpretation unbiased | UR | NR, same reference standard, NR | UR |
Mossner | Sampling from high-risk and low risk groups | UR | Not blinded, interpretation unbiased | UR | Not blinded, interpretation unbiased | UR | Sampling reported, same reference standard, all patients included in analysis | LR |
Nandagopal | NR | UR | NR | UR | NR | UR | NR | UR |
O Brien | No case control design, | LR | Blinded | LR | Blinded | LR | Sampling partly reported, same reference standard | LR |
Parker | Case control design | HR | Not blinded, interpretation unbiased | LR | Not blinded, interpretation unbiased | LR | Sampling partly reported, same reference standard | LR |
Ross | Possible case control design, sampling NR | HR | Not blinded, interpretation unbiased | LR | Not blinded, interpretation unbiased | LR | Flow reported | LR |
Sheperd | No case control design, but partly sampling from patients with known disease | LR | Not blinded, interpretation unbiased | LR | Not blinded, interpretation unbiased | LR | NR | UR |
Soulier | Sampling from high-risk and low risk-groups | HR | Not blinded, interpretation unbiased | LR | Not blinded, interpretation unbiased | LR | NR, same reference standard, NR | LR |
Tejada-Strop | Case control | HR | Not blinded, interpretation unbiased | LR | Not blinded, interpretation unbiased | LR | NR | UR |
Tuaillon, E | Case control | HR | Blinded | LR | Blinded | LR | Sampling reported, same reference standard | LR |
Waterboer, T | No case control | LR | Not blinded, interpretation unbiased | LR | Not blinded, interpretation unbiased | LR | NR | UR |