Background
Methods
Search strategy and identification of studies
Selection criteria
Data extraction and quality assessment
Data analysis and synthesis
Results
Study selection and characteristics
Study [author, year] | Location [country, city] | Sample size | Study design | Setting | Sample type | Assay under evaluation [type, brand] | Reference standard [type, brand] |
---|---|---|---|---|---|---|---|
Liu, 2014 [14] | China | 250 | CC | Hospital patients; outpatients (Preselected based on CMIA quantitative results) | Serum | ECLIA, Cobas ELISA, Wantai | CMIA, Architect HBsAg |
Peng, 2011 [49] | China | 498 | CC | Hospital patients (Preselected based on S/CO from KHB screen) | Serum | ELISA, KHB | CMIA, Architect HBsAg |
Geretti, 2010 [47] | Ghana, Kumasi | 838 | CS – CSQ | HIV clinic (1/3 on lamivudine) | Serum | CMIA, Architect HBsAg CMIA, Liaison Ultra EIA, Murex v3 | CMIA, Architect/ Liaison EIA, Murex v3a
|
Ol, 2009 [48] | Cambodia | 120 | CS – CSQ | Blood donors (rural community) | Serum | ELISA, Monolisa | CMIA, Architect HBsAg |
Viet, 2012 [50] | Vietnam | 119 | CS – CSQ | Blood donors (rural community) | Serum | EIA, Monolisa Ultra | CMIA, Architect HBsAg |
Study [author, year] | Total participants, n (substudy size, n) | Location [country, city] | Study design | Setting | Sample | RDT under evaluation [type, brand] | Reference test [type, brand] | |
---|---|---|---|---|---|---|---|---|
Mvere, 1996 [36] | 206 | Zimbabwe | CS | Blood Bank | S | Dipstick (PATH) SimpliRed | EIA, Auszyme | |
Sato, 1996 [42] | 462 | Japan | CC | Hospital | S | Dainascreen Serodia | EIA, Auszyme | |
Abraham, 1998 [20] | 450 | (50) | India, Vellore | CC– Panel | Hospital patients (Multiply transfused; chronic liver disease; preop and antenatal patients) | S | QuickChaser Virucheck | EIA, Auszyme or Hepanostika |
(400) | CS– Screen | |||||||
Oh, 1999 [38] | 250 | Korea | CC - Panel | Blood donor panel | S | Genedia Serodia | EIA, Cobas Core | |
Kaur, 2000 [30] | 2754 | India | CS - CSQ | Hospital Surgery patients; blood donors; patients ruling out HBV | S | Hepacard | EIA, Ortho 3rd generation | |
Lien, 2000 [33] | 328 | (328) | Vietnam | CC | High risk volunteers High-risk volunteers; pregnant women; patients with other infectious diseases (including 10 with HIV); preselected HBsAg pos (101), HBsAg neg (99) | SP | Dainascreen Determine Serodia | EIA, Monolisa MEIA for discordant |
(128) | CS | S P WB | Determine | |||||
Raj, 2001 [40] | 999 | India, Vellore | CS | Hospital laboratory samples (emergency preop screening; antenatal women in labour; haemodialysis; urgent donor screening) | S | Hepacard | EIA, Auszyme MEIA, AxSYM v2 | |
Clement, 2002 [27] | 942 | Belgium | CC | Hospital - Patients with biopsy proven HBV; healthy volunteers from a vaccine evaluation trial; blood donors | WB, S | BinaxNOW | MEIA, AxSYM v2 | |
Lau, 2003 [32] | 2463 | (1011) | USA | CS - CSQ | Hepatology clinics | S fresh | BinaxNOW | EIA, ETI-MAK2 |
(827) | CS | Incarcerated offenders | S frozen | |||||
(625) | CS - CSQ | Chinese Community Health Fair (random patients); known HBV-positive patients (liver clinic) | WB | |||||
Akanmu, 2006 [21] | 137 | (101) | Nigeria, Lagos | CS - CSQ | Blood donors (male) | WB | BinaxNOW | ELISA, Monolisa |
(36) | Chronic liver disease | |||||||
Nyirendra, 2008 [37] | 194 | Malawi | CS - CSQ | Hospital Hospital patients including 152 HIV+ | P | Determine | EIA, Bioelisa Neutralisation (positives) | |
Lin, 2008 [34] | 1250 | (671) | China | CC | Blood donors (500); Clinical specimens HBsAg + (171) | S | Determine DRW | EIA, Hepanostika Ultra |
(579) | Guinea | CC | Blood donors (491); Stored positives (88) | SP | ||||
Randrianirina, 2008 [41] | 200 | Madagascar | CC | Not specified | S | Cypress Determine Hexagon Virucheck | EIA, AxSYM | |
Ola, 2009 [39] | 80 | (25) | Nigeria | CS - CSQ | Medical clinic | WB | AMRAD GWHB | ELISA, Wellcozyme Kit |
(55) | Blood donors | S | Biotec Latex | |||||
Khan, 2010 [31] | 57 | Pakistan | CC | NS | S | Accurate Onecheck | ELISA, 2nd generation | |
Davies, 2010 [26] | 75 | Malawi | CS - CSQ | HIV-positive adults (ART naïve) | S | Determine | EIA, Biokit Neutralisation (positives) | |
Bjoerkvoll, 2010 [22] | 2400 | (1200) | Cambodia | CS - CSQ | General screen - Blood donors (rural) | S | ACON | EIA, Monolisa Ultraa
|
(1200) | Vietnam | |||||||
Geretti, 2010 [47] | 838 | Ghana, Kumasi | CS - CSQ | HIV-clinic (1/3 lamivudine) | S | Determine VIKIA | CMIA, Architect/ Liason EIA, Murex v3 | |
Hoffman, 2012 [45] | 973 | South Africa | CS - CSQ | HIV-positive adults (ART naïve) - Antenatal or primary care | WB (cap) | Determine | ELISA, AxSYM | |
Bottero, 2013 [23] | 3956 | (2472) | France, Paris | CS - CSQ | General Screening (healthcare centres) [General population prevention, screening, vaccination] | WB(ven) | Determine | ELISA, Monolisa Ultra Neutralisation (positives) |
(3922) | QUICK PROFILE | |||||||
(3928) | VIKIA | |||||||
Chameera, 2013 [24] | 50 | Sri Lanka | CS | Hospital (surgical, orther) | S | Cortez Onsite | EIA, Surase B-96 (TMB) | |
Franzeck, 2013 [44] | 272 | Tanzania, Ifakara | CS - CSQ | HIV-clinic (ART naïve) | WB(ven) P | Determine | EIA, Murex v3 Neutralisation (positives) | |
Chevaliez, 2014 [25] | 1768 | (558) | Various | CC | Chronic Hep B (known mutants, blood donors); HBsAg negative (mix, including HIV, 34; HCV, 48) | SP | DRW v2.0 | CMIA, Architect |
(408) | CS | Acute hepatitis | ||||||
(802) | CS | Pregnant - women at delivery | ||||||
Erhabor, 2014 [28] | 130 | Nigeria, Sokoto | CC | Blood donors | SP | ACON | ELISA, HBsAg Ultra | |
Gish, 2014 [29] | 297 | Australia, Melbourne | CS - CSQ | At risk Health fairs, outreach; Vietnamese (72%) | S | Nanosign | EIA, Quest Diagnostics | |
Honge, 2014 [46] | 438 | Guinea-Bissau | CS - CSQ | HIV clinic - mixed ART/ naïve | S | VEDA LAB | CMIA, Architect | |
Liu, 2014 [14] | 250 | China | CC | Hospital patients; outpatients (Preselected based on CMIA quantitative results) | S | Intec One Step | CMIA, Architect | |
Mutocheluh, 2014 [35] | 150 | Ghana | CS - CSQ | Blood donors | P | Abon Acull-Tell Core TM Rapid care Wondfo | ELISA, Human Gesellschaft | |
Upretti, 2014 [43] | 347 | Nepal | CS - CSQ | Children - pre and post vaccination; mothers (8) | S | SD Bioline | EIA, Surase B-96 (TMB) | |
Njai, 2015 [18] | 1000 | (178) | Gambia | CS | Hepatitis patients CHB carriers (study 3), incl 3 co-infected HIV (treatment naïve) | S | Determine | CMIA (quantitative), Architect |
(203) | Espline | |||||||
(773) | CS - CSQ | General Community Screen | WB | Determine | EIA (DBS), AxSym + Neutralisation | |||
(476) | VIKIA |
Study [author, year] | Location [country, city] | Sample size, n | Study design | Setting | Sample | Test under evaluation [type, brand] | Reference test [type, brand] |
---|---|---|---|---|---|---|---|
Ansari, 2007 [51] | Iran, Urumieh | 240 | CC | Hospital patients | S | RDT, ACON RDT, Atlas RDT, Blue Cross RDT, Cortez RDT, DIMA RDT, Intec | qPCR |
Nna, 2014 [52] | Nigeria | 113 | CS | Blood donors (repeat) – all were HIV negative | P | RDT, ACON | Nested PCR; qPCR for positive |
Seremba, 2010 [53] | Uganda | 157 | CS - CSQ | Hospital patients (emergency medical ward), including HIV+ (83) and HIV- (74). | S | RDT, Cortez EIA, ADVIA | PCR |
Khadem-Ansari, 2014 [54] | Iran, Urumieh | 350 | CS – CSQ? | Hospital patients - referred as? HBV | S | ChLIA, Liaison | Rt-PCR |
Lukhwareni, 2009 [56] | South Africa | 192 | CC | HIV cohort - pre ART | S | ChLIA, Elecsys | qPCR |
Mphahlele, 2006 [57] | South Africa | 295 | CC | Hospital patients, HIV+ (167) and HIV- (128) | S | EIA, AxSYM | Nested PCR |
Olinger, 2007 [55] | Nigeria, Ibadan | 200 | CS | Hospital patients - Liver disease, HIV | S | MEIA, AxSYM v2 ChLIA, Elecsys ELFA, VIDAS Ultra | rtPCR and nested PCR |
Assessment of the quality of the studies
Diagnostic accuracy of rapid tests for HBsAg detection
Index test | HIV status | Studies, n | Sample size (range), n | Data points, n | Pooled clinical accuracy (95% CI) | Likelihood ratios (95% CI) | ||
---|---|---|---|---|---|---|---|---|
Sensitivity | Specificity | Positive | Negative | |||||
RDT | NA | 30 | 23,716 (25–3928) | 63 | 90.0 (89.1–90.8) | 99.5 (99.4–99.5) | 117.5 (67.7–204.1) | 0.10 (0.07–0.14) |
HIV-positive | 5 | 2596 (75–973) | 6 | 72.3 (67.9–76.4) | 99.8 (99.5–99.9) | 192.6 (77.4–497.2) | 0.29 (0.22–0.38) | |
EIA | NA | 5 | 1825 (119–838) | 8 | 88.9 (87.0–90.6) | 98.4 (97.8–98.8) | 46.8 (12.9–170.0) | 0.04 (0.01–0.13) |
HIV-positive | 1 | 838 | 3 | 97.9 (96.0–99.0) | 99.4 (99.0–99.7) | 167.3 (95.1–294.1) | 0.02 (0.01–0.04) |
Subgroup | Studies, n | Sample size, n | Points, n | Pooled clinical accuracy (95% CI) | Likelihood ratios (95% CI) | |||
---|---|---|---|---|---|---|---|---|
Sensitivity | Specificity | Positive | Negative | |||||
Study | Pre 2005 | 9 | 8854 (206–2754) | 19 | 96.9 (96.0–97.7) | 99.7 (99.6–99.8) | 265.5 (106.1–664.5) | 0.06 (0.03–0.10) |
Post 2005 | 21 | 14,862 (25–3956) | 44 | 86.4 (85.2–87.5) | 99.4 (99.2–99.5) | 84.6 (43.6–164.6) | 0.13 (0.09–0.18) | |
HIV-positive | 5 | 2596 (75–973) | 6 | 72.3 (67.9–76.4) | 99.8 (99.5–99.9) | 192.6 (77.4–497.2) | 0.29 (0.22–0.38) | |
Specimen type | Whole blood | 8 | 6889 (25–3956) | 11 | 91.7 (89.1–93.9) | 99.9 (99.8–99.9) | 346.6 (157.6–762.4) | 0.09 (0.06–0.14) |
Index test | Determine | 10 | 7730 (75–2472) | 12 | 90.8 (88.9–92.4) | 99.1 (98.9–99.4) | 239 (17.1–33,300) | 0.077 (0.035–0.168) |
VIKIA | 3 | 5242 (476–3928) | 3 | 82.5 (77.5–86.7) | 99.9 (99.8–100) | 1070 (376–3060) | 0.108 (0.026–0.458) | |
BinaxNOW | 3 | 3542 (137–2463) | 6 | 97.6 (96.2–98.6) | 100 (99.7–100) | 221 (36.1–1350) | 0.045 (0.016–0.128) | |
Serodia | 3 | 1040 (250–462) | 3 | 95.8 (93.4–97.5) | 99.8 (99.1–100) | 285 (71.4–1140) | 0.045 (0.029–0.069) | |
Reference test | CMIA | 5 | 3521 (227–1768) | 9 | 80.4 (77.9–82.6) | 99.0 (99.6–99.3) | 58.5 (31.3–109) | 0.141 (0.074–0.268) |