Assessment of rapid diagnostic tests and fourth-generation Enzyme-Linked Immunosorbent Assays in the screening of Human Immunodeficiency and Hepatitis B virus infections among first-time blood donors in Libreville (Gabon)

Jean Marie Eko Mba, Cyrille Bisseye, Landry Erik Mombo, Jophrette Mireille Ntsame Ndong, Schella Carlaye Mbina Ekayeng, Calixte Bengone, Bertrand M’batchi, Bolni Nagalo

Research output: Contribution to journalArticle

Abstract

Background: Blood transfusion is a pathway for the transmission of blood-borne pathogens such as human immunodeficiency virus (HIV) and hepatitis B virus (HBV) from donors to recipients in most countries in sub-Saharan Africa, including Gabon. The study aimed to compare the performance of four rapid diagnostic tests (RDTs: Alere DETERMINE, BIOSYNEX Exacto Pro HIV, MEDIFF HIV 1&2, and BIOSYNEX IMMUNOQUICK HBsAg) with results of 4th-generation immunoenzymatic assays COBAS 6000 e601 and EVOLIS BioRad for the detection of HIV and hepatitis B surface antigen (HBsAg) in blood donors in Libreville, Gabon. Methods: Reactive and nonreactive blood samples for HIV and HBsAg were selected using fourth-generation ELISA COBAS 6000 e601 and EVOLIS BioRad. The sensitivities of RDTs were calculated using Epi Info version 6.04dfr (CDC, Atlanta, USA). Results: Sensitivities for the detection of HIV in blood donors were 90.9% for Alere DETERMINE, 81.8% for BIOSYNEX Exacto Pro HIV, and 81.8% for MEDIFF HIV 1&2 Serum/sang Total Cassette compared with COBAS 6000 e601. The sensitivity of Alere DETERMINE compared to the semi-automated ELISA Bio-Rad for HIV detection was 65.6%. The sensitivity of BIOSYNEX IMMUNOQUICK HBsAg compared to ELISA tests for the detection of HBsAg was 78.0%. The specificity of all RDTs for the detection of HIV and HBsAg was 100%. Conclusion: Alere DETERMINE HIV-1/2, MEDIFF HIV 1&2 Serum/sang Total Cassette, BIOSYNEX Exacto Pro HIV, and BIOSYNEX IMMUNOQUICK HBsAg are not recommended for determining whether donors qualify to donate blood because of their low sensitivity for the detection of HIV antibodies and HBsAg in blood donors in Gabon.

Original languageEnglish (US)
Article numbere22824
JournalJournal of Clinical Laboratory Analysis
Volume33
Issue number3
DOIs
StatePublished - Mar 1 2019

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Gabon
Immunosorbents
Virus Diseases
Blood Donors
Viruses
Routine Diagnostic Tests
Hepatitis B virus
Assays
Hepatitis B Surface Antigens
Screening
Blood
Enzyme-Linked Immunosorbent Assay
HIV
Enzymes
HIV-1
Tissue Donors
Blood-Borne Pathogens
HIV-2
Africa South of the Sahara
Centers for Disease Control and Prevention (U.S.)

Keywords

  • hepatitis B surface antigen
  • human immunodeficiency virus
  • Libreville
  • rapid detection test
  • sensitivity

ASJC Scopus subject areas

  • Immunology and Allergy
  • Hematology
  • Public Health, Environmental and Occupational Health
  • Clinical Biochemistry
  • Medical Laboratory Technology
  • Biochemistry, medical
  • Microbiology (medical)

Cite this

Assessment of rapid diagnostic tests and fourth-generation Enzyme-Linked Immunosorbent Assays in the screening of Human Immunodeficiency and Hepatitis B virus infections among first-time blood donors in Libreville (Gabon). / Eko Mba, Jean Marie; Bisseye, Cyrille; Mombo, Landry Erik; Ntsame Ndong, Jophrette Mireille; Mbina Ekayeng, Schella Carlaye; Bengone, Calixte; M’batchi, Bertrand; Nagalo, Bolni.

In: Journal of Clinical Laboratory Analysis, Vol. 33, No. 3, e22824, 01.03.2019.

Research output: Contribution to journalArticle

Eko Mba, Jean Marie ; Bisseye, Cyrille ; Mombo, Landry Erik ; Ntsame Ndong, Jophrette Mireille ; Mbina Ekayeng, Schella Carlaye ; Bengone, Calixte ; M’batchi, Bertrand ; Nagalo, Bolni. / Assessment of rapid diagnostic tests and fourth-generation Enzyme-Linked Immunosorbent Assays in the screening of Human Immunodeficiency and Hepatitis B virus infections among first-time blood donors in Libreville (Gabon). In: Journal of Clinical Laboratory Analysis. 2019 ; Vol. 33, No. 3.
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abstract = "Background: Blood transfusion is a pathway for the transmission of blood-borne pathogens such as human immunodeficiency virus (HIV) and hepatitis B virus (HBV) from donors to recipients in most countries in sub-Saharan Africa, including Gabon. The study aimed to compare the performance of four rapid diagnostic tests (RDTs: Alere DETERMINE, BIOSYNEX Exacto Pro HIV, MEDIFF HIV 1&2, and BIOSYNEX IMMUNOQUICK HBsAg) with results of 4th-generation immunoenzymatic assays COBAS 6000 e601 and EVOLIS BioRad for the detection of HIV and hepatitis B surface antigen (HBsAg) in blood donors in Libreville, Gabon. Methods: Reactive and nonreactive blood samples for HIV and HBsAg were selected using fourth-generation ELISA COBAS 6000 e601 and EVOLIS BioRad. The sensitivities of RDTs were calculated using Epi Info version 6.04dfr (CDC, Atlanta, USA). Results: Sensitivities for the detection of HIV in blood donors were 90.9{\%} for Alere DETERMINE, 81.8{\%} for BIOSYNEX Exacto Pro HIV, and 81.8{\%} for MEDIFF HIV 1&2 Serum/sang Total Cassette compared with COBAS 6000 e601. The sensitivity of Alere DETERMINE compared to the semi-automated ELISA Bio-Rad for HIV detection was 65.6{\%}. The sensitivity of BIOSYNEX IMMUNOQUICK HBsAg compared to ELISA tests for the detection of HBsAg was 78.0{\%}. The specificity of all RDTs for the detection of HIV and HBsAg was 100{\%}. Conclusion: Alere DETERMINE HIV-1/2, MEDIFF HIV 1&2 Serum/sang Total Cassette, BIOSYNEX Exacto Pro HIV, and BIOSYNEX IMMUNOQUICK HBsAg are not recommended for determining whether donors qualify to donate blood because of their low sensitivity for the detection of HIV antibodies and HBsAg in blood donors in Gabon.",
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AU - Eko Mba, Jean Marie

AU - Bisseye, Cyrille

AU - Mombo, Landry Erik

AU - Ntsame Ndong, Jophrette Mireille

AU - Mbina Ekayeng, Schella Carlaye

AU - Bengone, Calixte

AU - M’batchi, Bertrand

AU - Nagalo, Bolni

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N2 - Background: Blood transfusion is a pathway for the transmission of blood-borne pathogens such as human immunodeficiency virus (HIV) and hepatitis B virus (HBV) from donors to recipients in most countries in sub-Saharan Africa, including Gabon. The study aimed to compare the performance of four rapid diagnostic tests (RDTs: Alere DETERMINE, BIOSYNEX Exacto Pro HIV, MEDIFF HIV 1&2, and BIOSYNEX IMMUNOQUICK HBsAg) with results of 4th-generation immunoenzymatic assays COBAS 6000 e601 and EVOLIS BioRad for the detection of HIV and hepatitis B surface antigen (HBsAg) in blood donors in Libreville, Gabon. Methods: Reactive and nonreactive blood samples for HIV and HBsAg were selected using fourth-generation ELISA COBAS 6000 e601 and EVOLIS BioRad. The sensitivities of RDTs were calculated using Epi Info version 6.04dfr (CDC, Atlanta, USA). Results: Sensitivities for the detection of HIV in blood donors were 90.9% for Alere DETERMINE, 81.8% for BIOSYNEX Exacto Pro HIV, and 81.8% for MEDIFF HIV 1&2 Serum/sang Total Cassette compared with COBAS 6000 e601. The sensitivity of Alere DETERMINE compared to the semi-automated ELISA Bio-Rad for HIV detection was 65.6%. The sensitivity of BIOSYNEX IMMUNOQUICK HBsAg compared to ELISA tests for the detection of HBsAg was 78.0%. The specificity of all RDTs for the detection of HIV and HBsAg was 100%. Conclusion: Alere DETERMINE HIV-1/2, MEDIFF HIV 1&2 Serum/sang Total Cassette, BIOSYNEX Exacto Pro HIV, and BIOSYNEX IMMUNOQUICK HBsAg are not recommended for determining whether donors qualify to donate blood because of their low sensitivity for the detection of HIV antibodies and HBsAg in blood donors in Gabon.

AB - Background: Blood transfusion is a pathway for the transmission of blood-borne pathogens such as human immunodeficiency virus (HIV) and hepatitis B virus (HBV) from donors to recipients in most countries in sub-Saharan Africa, including Gabon. The study aimed to compare the performance of four rapid diagnostic tests (RDTs: Alere DETERMINE, BIOSYNEX Exacto Pro HIV, MEDIFF HIV 1&2, and BIOSYNEX IMMUNOQUICK HBsAg) with results of 4th-generation immunoenzymatic assays COBAS 6000 e601 and EVOLIS BioRad for the detection of HIV and hepatitis B surface antigen (HBsAg) in blood donors in Libreville, Gabon. Methods: Reactive and nonreactive blood samples for HIV and HBsAg were selected using fourth-generation ELISA COBAS 6000 e601 and EVOLIS BioRad. The sensitivities of RDTs were calculated using Epi Info version 6.04dfr (CDC, Atlanta, USA). Results: Sensitivities for the detection of HIV in blood donors were 90.9% for Alere DETERMINE, 81.8% for BIOSYNEX Exacto Pro HIV, and 81.8% for MEDIFF HIV 1&2 Serum/sang Total Cassette compared with COBAS 6000 e601. The sensitivity of Alere DETERMINE compared to the semi-automated ELISA Bio-Rad for HIV detection was 65.6%. The sensitivity of BIOSYNEX IMMUNOQUICK HBsAg compared to ELISA tests for the detection of HBsAg was 78.0%. The specificity of all RDTs for the detection of HIV and HBsAg was 100%. Conclusion: Alere DETERMINE HIV-1/2, MEDIFF HIV 1&2 Serum/sang Total Cassette, BIOSYNEX Exacto Pro HIV, and BIOSYNEX IMMUNOQUICK HBsAg are not recommended for determining whether donors qualify to donate blood because of their low sensitivity for the detection of HIV antibodies and HBsAg in blood donors in Gabon.

KW - hepatitis B surface antigen

KW - human immunodeficiency virus

KW - Libreville

KW - rapid detection test

KW - sensitivity

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