Analytical performance of eight rapid point-of-care tests routinely used for the detection of HBsAg in Burkina Faso: A cross-sectional study

Sanou, Armel M.; Toyé, Rayana Maryse; Kagoné, Thérèse; Nikièma, Abdoulaye; Testa, J.; Sakandé, Jean; Sangaré, Lassana; Tarnagda, Zékiba; Kania, Dramane

doi:10.1016/j.jcv.2020.104546

Cited by 9 publications

(7 citation statements)

References 13 publications

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“…In our study, assessment of participants' knowledge about viral hepatitis revealed that half of the donors (48.68%) had never heard of viral hepatitis and 75.54% had no information on transmission routes, confirming data we reported earlier 13 . Interestingly, a positive correlation (OR: 6.38; 95% CI: 1.15, 35.40) was found between the knowledge of the transmission routes and HBV seronegativity in the participants of this study (Table 4).…”

Section: Discussionsupporting

confidence: 90%

“…Although offering economic advantages for resource‐limited countries, the imperfect sensitivity of these tests, raise concerns about the safety of the blood transfusion system. 13 Previous studies reported data on the performance of the rapid tests in blood donors suggesting a potential risk of posttransfusion infections. 15 , 16 , 17 , 18 To our knowledge, although widely used for the biological qualification of donations in Burkina Faso, no studies to date have evaluated the residual risk of pathogen transmission following the use of RDTs.…”

Section: Introductionmentioning

confidence: 99%

“…However, because EIA and CLIA are not available everywhere, and centralized testing has shown its limitations, several health facilities implement BTS through rapid test‐based screenings. Although offering economic advantages for resource‐limited countries, the imperfect sensitivity of these tests, raise concerns about the safety of the blood transfusion system 13 . Previous studies reported data on the performance of the rapid tests in blood donors suggesting a potential risk of posttransfusion infections 15–18 .…”

Section: Introductionmentioning

confidence: 99%

“…1 In Burkina Faso, with respective prevalence rates of 9.1%, 3.6%, and 0.8% in the general population, HBV, HCV, and HIV infections remain major public health problems. 7,8 Likewise, high prevalences of these pathogens were also reported among blood donors [9][10][11][12][13] highlighting the risk of transmission through blood transfusion. Blood transfusion safety (BTS) in the country is effective since 2000 and is implemented by the National Blood Transfusion Center (NBTC).…”

mentioning

confidence: 99%

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Residual risk of hepatitis B virus transmission through blood donations in Burkina Faso screened with rapid diagnostic tests

Sanou

Nikièma

Zalla³

et al. 2022

Health Science Reports

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Background and Aims hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV) represent the major transfusion–transmissible pathogens worldwide. The risk of transmission is relatively high in African countries, mainly due to unreliable screening methods of blood donations. In Burkina Faso, predonation screening using rapid diagnostic tests (RDTs) is widespread, raising the major question of the transfusion safety in the country. The objective of this study was to assess the risk of transmission of HBV, HCV, and HIV through blood transfusion in the context of the use of RDTs for screening of the blood donations. Methods In this cross‐sectional study, a total of 417 serum samples obtained from blood donors tested negative for HBsAg, anti‐HCV, and anti‐HIV using RDTs were retested for the same markers using chemiluminescent immunologic assays. Total antibodies to HBV core (anti‐HBc) were tested on randomly selected samples. HBV‐DNA and HCV‐RNA viral loads (VLs) were quantified on HBsAg and anti‐HCV positive samples, respectively. To assess possible occult hepatitis B infection (OBI), HBV‐DNA‐VL was quantified on 313 randomly selected HBsAg‐negative samples. Results HBsAg and anti‐HCV were found respectively in 6 (6/417; 1.4%) and 11 (11/417; 2.6%) samples. No samples were reactive for anti‐HIV. Total anti‐HBc were detected in 217 out of the 319 randomly selected samples (217/319; 68.02%). HBV‐DNA was detected in four (4/313; 1.27%) samples, including two (2/6; 33.33%) of the six HBsAg positive samples and two (2/313; 0.6%) of the HBsAg‐negative samples, suggesting two cases of occult HBV infection. All anti‐HCV antibody‐positive samples were HCV‐RNA negative. Conclusion This study shows that RDTs are not sufficiently sensitive for the screening of blood donations. Our results highlight the urgent need to think about the extension of sensitive immunological tests in all blood transfusion centers and also the implementation of nucleic acid amplification techniques.

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Section: Discussionsupporting

confidence: 90%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

mentioning

confidence: 99%

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Residual risk of hepatitis B virus transmission through blood donations in Burkina Faso screened with rapid diagnostic tests

Sanou

Nikièma

Zalla³

et al. 2022

Health Science Reports

Self Cite

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“…Unlike standard testing methods such as EIA and NAT, RDT can usually be performed without electricity or need for standard laboratory equipment (57) (103,108). A similar study in Burkina Faso also yielded good sensitivities (range of 90.8-92.8%) and excellent specificities (range of 97.3 to ≥99.0%) indicating usefulness of RDT for HBV mass screening in Burkina Faso (124). RDTs carry certain risks for use in blood screening; those tests having lower sensitivity may yield false negative results, particularly in the presence of low HBsAg or HBV/HCV antibody titres, or mutations within the HBsAg antigenic determinant may also prevent accurate detection of HBV infection (102,125).…”

Section: Utility Of Hbv and Hcv Rapid Diagnostic Tests In Lmicmentioning

confidence: 93%

Rapid Diagnostics for Hepatitis B and C Viruses in Low- and Middle-Income Countries

Shenge¹,

Osiowy

2021

Front.Virol.

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The global health challenge posed by hepatitis B virus (HBV) and hepatitis C virus (HCV) persists, especially in low-and-middle-income countries (LMICs), where underdiagnosis of these viral infections remains a barrier to the elimination target of 2030. HBV and HCV infections are responsible for most liver-related mortality worldwide. Infected individuals are often unaware of their condition and as a result, continue to transmit these viruses. Although conventional diagnostic tests exist, in LMIC they are largely inaccessible due to high costs or a lack of trained personnel, resulting in poor linkage to care and increased infections. Timely and accurate diagnosis is needed to achieve elimination of hepatitis B and C by the year 2030 as set out by the World Health Organization Global Health Sector Strategy. In this review rapid diagnostic tests allowing for quick and cost-effective screening and diagnosis of HBV and HCV, are discussed, as are their features, including suitability, reliability, and applicability in LMIC, particularly those within Africa.

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One-step multiplex DiRT-PCR for PLRV, PVY, PVM, PVS, PVA and PVX ready for routine testing directly on tuber sap

2023

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Potato viruses PLRV, PVY, PVM, PVA, PVX and PVS can cause up to 90% loss of potato harvest. Therefore, they are monitored by law in many countries using DAS-ELISA or conventional real-time RT-qPCR. Previously, we developed a multiplex real-time DiRT-PCR (Direct reverse transcript – polymerase chain reaction), which works directly on diluted tuber sap and thus saves time and chemical processing for RNA extraction or time and space in the glasshouse. So far, this method only ran on sap of single tubers which is not practical for routine testing. We are now able to sensitively test for the presence of six viruses in two multiplex reactions using the real-time DiRT-PCR on pooled samples of ten tubers. Here we show that there is an “almost perfect” agreement (Gwet’s AC1 index) comparing this multiplex real-time DiRT-PCR on pooled samples with DAS-ELISA and a commercial RT-qPCR kit with a rapid extraction method. The multiplex real-time DiRT-PCR is now ready to be used for routine testing.

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Analytical performance of eight rapid point-of-care tests routinely used for the detection of HBsAg in Burkina Faso: A cross-sectional study

Cited by 9 publications

References 13 publications

Residual risk of hepatitis B virus transmission through blood donations in Burkina Faso screened with rapid diagnostic tests

Residual risk of hepatitis B virus transmission through blood donations in Burkina Faso screened with rapid diagnostic tests

Rapid Diagnostics for Hepatitis B and C Viruses in Low- and Middle-Income Countries

One-step multiplex DiRT-PCR for PLRV, PVY, PVM, PVS, PVA and PVX ready for routine testing directly on tuber sap

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