Comparative multi-assay evaluation of Determine™ HIV-1/2 Ag/Ab Combo rapid diagnostic tests in acute and chronic HIV infection.


:In resource-limited or point-of-care settings, rapid diagnostic tests (RDTs), that aim to simultaneously detect HIV antibodies and p24 capsid (p24CA) antigen with high sensitivity, can pose important alternatives to screen for early infections. We evaluated the performance of the antibody and antigen components of the old and novel version of the Determine™ HIV-1/2 Ag/Ab Combo RDTs in parallel to quantifications in a fourth-generation antigen/antibody immunoassay (4G-EIA), p24CA antigen immunoassay (p24CA-EIA), immunoblots, and nucleic acid quantification. We included plasma samples of acute, treatment-naïve HIV-1 infections (Fiebig stages I-VI, subtypes A1, B, C, F, CRF02_AG, CRF02_AE, URF) or chronic HIV-1 and HIV-2 infections. The tests' antigen component was evaluated also for a panel of subtype B HIV-1 transmitted/founder (T/F) viruses, HIV-2 strains and HIV-2 primary isolates. Furthermore, we assessed the analytical sensitivity of the RDTs to detect p24CA using a highly purified HIV-1NL4-3 p24CA standard. We found that 77% of plasma samples from acutely infected, immunoblot-negative HIV-1 patients in Fiebig stages II-III were identified by the new RDT, while only 25% scored positive in the old RDT. Both RDTs reacted to all samples from chronically HIV-1-infected and acutely HIV-1-infected patients with positive immunoblots. All specimens from chronically infected HIV-2 patients scored positive in the new RDT. Of note, the sensitivity of the RDTs to detect recombinant p24CA from a subtype B virus ranged between 50 and 200 pg/mL, mirrored also by the detection of HIV-1 T/F viruses only at antigen concentrations tenfold higher than suggested by the manufacturer. The RTD failed to recognize any of the HIV-2 viruses tested. Our results indicate that the new version of the Determine™ HIV-1/2 Ag/Ab Combo displays an increased sensitivity to detect HIV-1 p24CA-positive, immunoblot-negative plasma samples compared to the precursor version. The sensitivity of 4G-EIA and p24CA-EIA to detect the major structural HIV antigen, and thus to diagnose acute infections prior to seroconversion, is still superior.


Med Microbiol Immunol


Wratil PR,Rabenau HF,Eberle J,Stern M,Münchhoff M,Friedrichs I,Stürmer M,Berger A,Kuttner-May S,Münstermann D,Lucht A,Meixenberger K,Bannert N,Keppler OT




Has Abstract


2020-04-01 00:00:00














  • Generation, characterization and cross-reactivities of monoclonal antibodies against the p24 core protein and the gp130 envelope glycoprotein of HIV-2ben.

    abstract::The purpose of this study was to characterize antigenic determinants on structural polypeptides of human immunodeficiency virus type 2 (HIV-2ben). Therefore, three HIV-2-specific monoclonal antibodies (mAbs) against the p24 core protein (gag) and one mAb against the gp130 envelope glycoprotein (env) were produced. In ...

    journal_title:Medical microbiology and immunology

    pub_type: 杂志文章


    authors: Faisst AC,Otteken A,Nick S,Hunsmann G

    更新日期:1993-07-01 00:00:00

  • Herpes simplex and varicella-zoster virus infections during pregnancy: current concepts of prevention, diagnosis and therapy. Part 2: Varicella-zoster virus infections.

    abstract::Varicella during pregnancy can be associated with severe illnesses for both the mother and her neonate. Varicella pneumonia must be regarded as a medical emergency, since pregnant women are at risk of life-threatening ventilatory compromise and death. After maternal chickenpox in the first and second trimesters, conge...

    journal_title:Medical microbiology and immunology

    pub_type: 杂志文章,评审


    authors: Sauerbrei A,Wutzler P

    更新日期:2007-06-01 00:00:00

  • Enterotoxigenic Escherichia coli (ETEC) isolated in the Tel-Aviv (Israel) area.

    abstract::The prevalence of enterotoxigenic E coli (ETEC) as a pathogenic agent of diarrhoea in the Tel-Aviv (Israel) area was determined, and the isolated E. coli strains characterized. During three periods (summer 1977, summer 1978, and summer 1979), a total of 335 specimens were tested for the presence of E. coli producing L...

    journal_title:Medical microbiology and immunology

    pub_type: 杂志文章


    authors: Goldhar J,Peri R,Zilberberg R,Lahav M

    更新日期:1980-01-01 00:00:00

  • Isolation of a 33-kDa protein antigen from delipidified Mycobacterium tuberculosis H37Rv.

    abstract::A 33-kDa protein (TB33) was isolated from a delipidated cell sonicate (CS) of Mycobacterium tuberculosis H37Rv (grown in Middlebrook 7H9 broth supplemented with glucose) using immobilized metal affinity chromatography (IMAC) on a nickel-nitrilotriacetic acid (Ni-NTA) column. TB33 could not be isolated from the culture...

    journal_title:Medical microbiology and immunology

    pub_type: 杂志文章


    authors: Deshpande RG,Khan MB,Bhat DA,Navalkar RG

    更新日期:1996-11-01 00:00:00

  • Characterization of the subcellular localization of herpes simplex virus type 1 proteins in living cells.

    abstract::In this study, we presented the construction of a library of expression clones for the herpes simplex virus type 1 (HSV-1) proteome and subcellular localization map of HSV-1 proteins in living cells using yellow fluorescent protein (YFP) fusion proteins. As a result, 21 proteins showed cytoplasmic or subcytoplasmic lo...

    journal_title:Medical microbiology and immunology

    pub_type: 杂志文章


    authors: Xing J,Wang S,Li Y,Guo H,Zhao L,Pan W,Lin F,Zhu H,Wang L,Li M,Wang L,Zheng C

    更新日期:2011-02-01 00:00:00

  • Molecular interaction between prion protein and GFAP both in native and recombinant forms in vitro.

    abstract::Gliosis of glial fibrillary acidic protein (GFAP) associated astrocytes is considered to be one of the hallmarks of transmissible spongiform encephalopathies (TSEs). In the present study, remarkable GFAP-PrP(Sc) or GFAP-PrP(C) complexes were separately detected in the brain homogenates of 263 K (Scrapie)-infected or n...

    journal_title:Medical microbiology and immunology

    pub_type: 杂志文章


    authors: Dong CF,Wang XF,Wang X,Shi S,Wang GR,Shan B,An R,Li XL,Zhang BY,Han J,Dong XP

    更新日期:2008-12-01 00:00:00

  • Cytotoxic effects of a leukocidin from Fusobacterium necrophorum on bovine hepatic cells.

    abstract::Cytotoxic effects of a leukocidin from Fusobacterium necrophorum were demonstrated on bovine hepatic cells. The cytotoxic response was dose-dependent and could be inhibited by homologous antiserum. Scanning electron microscopy revealed damaged hepatic cell surface. These findings indicated a pathogenic role of the leu...

    journal_title:Medical microbiology and immunology

    pub_type: 杂志文章


    authors: Ishii T,Kanoe M,Inoue T,Kai K,Blobel H

    更新日期:1988-01-01 00:00:00

  • Clinical evaluation of prophylactic intranasal 1-phenyl-3-(4-phenyl-2-thiazolyl) guanidine (CL 88,277) medication against rhinovirus 44 challenge.

    abstract::The prophylactic intranasal medication with a new antiviral compound, 1-phenyl-3-(4 phenyl-2-thiazolyl) guanidine (CL 88,277) was evaluated in humans against rhinovirus 44 challenge. One ml containing 250 mg of CL 88,277 was administered to 10 seronegative volunteers three times a day plus one dose prior to the rhinov...

    journal_title:Medical microbiology and immunology

    pub_type: 临床试验,杂志文章


    authors: Togo Y,Durr FE,Laurenzana DA

    更新日期:1977-05-18 00:00:00

  • Simian rotavirus (SA 11) in serodiagnosis of human rotavirus infections.

    abstract::Tests were made on 169 sera from children up to 10 years of age for rotavirus antibodies by indirect immunofluorescence and complement fixation tests. The simian strain SA 11 served as a substitute antigen for the human rotavirus. Furthermore, the SA 11 complement-fixing antigen was compared with a commercial antigen ...

    journal_title:Medical microbiology and immunology

    pub_type: 杂志文章


    authors: Brade L,Schmidt WA

    更新日期:1979-03-13 00:00:00

  • Comparative study on the immunostimulatory potency of different Propionibacterium strains.

    abstract::198 strains of Propionibacterium acnes, P. avidum, and P. granulosum were tested for their immunostimulatory potency using splenomegaly as index of stimulation, the activity differed widely from strain to strain. The antitumor and antimetastatic properties of six strains with differing stimulation activities were care...

    journal_title:Medical microbiology and immunology

    pub_type: 杂志文章


    authors: Ko HL,Roszkowski W,Jeljaszewicz J,Pulverer G

    更新日期:1981-01-01 00:00:00

  • Hemolytic properties and riboflavin synthesis of Helicobacter pylori: cloning and functional characterization of the ribA gene encoding GTP-cyclohydrolase II that confers hemolytic activity to Escherichia coli.

    abstract::Various strains of Helicobacter pylori were able to lyse erythrocytes from sheep, horse, and human when grown on blood agar. The hemolysis did not depend on the production of the vacuolating cytotoxin VacA as demonstrated by the hemolytic behavior of an isogenic vacA-negative mutant strain. The hemolytic activity coul...

    journal_title:Medical microbiology and immunology

    pub_type: 杂志文章


    authors: Bereswill S,Fassbinder F,Völzing C,Covacci A,Haas R,Kist M

    更新日期:1998-03-01 00:00:00

  • Immunoblot using recombinant antigens derived from different genospecies of Borrelia burgdorferi sensu lato.

    abstract::Immunodominant proteins are variable in molecular and antigenic structure among different genospecies of Borrelia burgdorferi sensu lato. We have recently developed an immunoblot using five recombinant antigens: the chromosomal-encoded B. burgdorferi proteins p100, the flagellin and an internal flagellin fragment ther...

    journal_title:Medical microbiology and immunology

    pub_type: 杂志文章


    authors: Wilske B,Fingerle V,Preac-Mursic V,Jauris-Heipke S,Hofmann A,Loy H,Pfister HW,Rössler D,Soutschek E

    更新日期:1994-02-01 00:00:00

  • Oral manifestations in HIV infection: fungal and bacterial infections, Kaposi's sarcoma.

    abstract::Oral candidiasis (OC) is a frequent oral manifestation of HIV infection, is a marker disease and occurs as a pseudomembranous, erythematous or rarely hyperplastic variant; angular cheilitis is also seen. Candida albicans is frequently isolated but other species such as C. krusei and C. dublienensis are emerging. Resis...

    journal_title:Medical microbiology and immunology

    pub_type: 杂志文章,评审


    authors: Reichart PA

    更新日期:2003-08-01 00:00:00

  • Characterization of Borrelia burgdorferi sensu lato strains isolated from Ixodes ricinus in Mecklenburg-Vorpommern, Germany.

    abstract::Epidemiological studies in Mecklenburg-Vorpommern have shown a high prevalence of Borrelia burgdorferi-infected ticks. A total of 17 B. burgdorferi sensu lato strains were isolated from ticks and investigated by Western blots (immunoblot) with eight monoclonal anti-bodies against different epitopes of the outer surfac...

    journal_title:Medical microbiology and immunology

    pub_type: 杂志文章


    authors: Lottmann H,Wilske B,Herrmann H

    更新日期:1996-02-01 00:00:00

  • Tetraspanins in mammalian reproduction: spermatozoa, oocytes and embryos.

    abstract::It is known that tetraspanin proteins are involved in many physiological somatic cell mechanisms. Additionally, research has indicated they also have a role in various infectious diseases and cancers. This review focuses on the molecular interactions underlying the tetraspanin web formation in gametes. Primarily, tetr...

    journal_title:Medical microbiology and immunology

    pub_type: 杂志文章,评审


    authors: Jankovičová J,Neuerová Z,Sečová P,Bartóková M,Bubeníčková F,Komrsková K,Postlerová P,Antalíková J

    更新日期:2020-08-01 00:00:00

  • Enhancement of the pathogenicity of Staphylococcus aureus strain Newman by a small noncoding RNA SprX1.

    abstract::The pathogenesis of Staphylococcus aureus from local infection to systemic dissemination involves a range of virulence factors including structural and secreted products. Among various control mechanisms, small noncoding RNAs are involved in the regulation of multiple pathogenicity factors in S. aureus. The sRNA SprX ...

    journal_title:Medical microbiology and immunology

    pub_type: 杂志文章


    authors: Kathirvel M,Buchad H,Nair M

    更新日期:2016-12-01 00:00:00

  • Evaluation of a defined medium for the production of both thermolabile (LT) and thermostable (ST) enterotoxins of Escherichia coli.

    abstract::The production of thermolabile (LT) enterotoxin was compared in a defined medium reported by Staples et al. (SAG medium) for the production of thermostable (ST) enterotoxin and the Casamino acids-Yeast extract (CAYE) medium. Aliquots were drawn frum cultures of an enterotoxigenic (LT+, ST+) E. coli in both media at di...

    journal_title:Medical microbiology and immunology

    pub_type: 杂志文章


    authors: Fontes CF,Ricci LC,Oliveira MS,Gatti MS,Pestana de Castro AF

    更新日期:1982-01-01 00:00:00

  • Kaposi's sarcoma-associated herpesvirus seroprevalence in selected german patients: evaluation by different test systems.

    abstract::A total of 603 serum samples obtained from 12 different patient and control groups, including potentially cross-reactive sera, were tested for the presence of antibodies against Kaposi's sarcoma-associated herpesvirus (KSHV, HHV-8). The assays used were an inhouse immunofluorescence test (IFT) employing latent KSHV an...

    journal_title:Medical microbiology and immunology

    pub_type: 杂志文章


    authors: Preiser W,Szép NI,Lang D,Doerr HW,Rabenau HF

    更新日期:2001-12-01 00:00:00

  • Identification of shared antigenic determinants of different polypeptides from Davis and Towne cytomegalovirus strains with monoclonal antibodies.

    abstract::Six colonies producing antibodies were obtained by fusing mouse myeloma SP2-O cells with spleen cells from mice immunized with cytomegalovirus Davis strain. Among 88 surviving clones, 29 produced antibodies detectable by immunofluorescence on infected MRC5 cells and 2 others produced neutralizing antibodies against a ...

    journal_title:Medical microbiology and immunology

    pub_type: 杂志文章


    authors: Chardonnet Y,Léry X,Revillard JP

    更新日期:1983-01-01 00:00:00

  • Circumventing failed antiviral immunity in chronic hepatitis B virus infection: triggering virus-specific or innate-like T cell response?

    abstract::Therapeutic vaccination for the treatment of chronic hepatitis B has thus far been unsatisfactory. In this review, we discuss potential new therapeutic vaccination strategies and other immunotherapeutic approaches that aim to achieve efficient restoration of HBV immunity in chronically infected patients. ...

    journal_title:Medical microbiology and immunology

    pub_type: 杂志文章,评审


    authors: Koh S,Bertoletti A

    更新日期:2015-02-01 00:00:00

  • The microbiology and treatment of human mastitis.

    abstract::Mastitis, which is generally described as an inflammation of breast tissue, is a common and debilitating disease which frequently results in the cessation of exclusive breastfeeding and affects up to 33% of lactating women. The condition is a primary cause of decreased milk production and results in organoleptic and n...

    journal_title:Medical microbiology and immunology

    pub_type: 杂志文章,评审


    authors: Angelopoulou A,Field D,Ryan CA,Stanton C,Hill C,Ross RP

    更新日期:2018-04-01 00:00:00

  • Human T helper cells reactive with somatic bacterial antigens belong to the Th1 subset.

    abstract::The aim of this study was to characterize the cytokine secretion patterns of human T helper cells from healthy donors reactive with somatic antigens from various bacteria, the nematode Anisakis and tetanus toxoid. From the peripheral blood of four healthy donors we have established 70 T cell lines reactive with antige...

    journal_title:Medical microbiology and immunology

    pub_type: 杂志文章


    authors: Schlaak JF,Nieder P,Meyer zum Büschenfelde KH,Fleischer B

    更新日期:1994-07-01 00:00:00

  • Burkholderia pseudomallei induces IL-23 production in primary human monocytes.

    abstract::Burkholderia pseudomallei, a gram-negative intracellular bacterium, is a causative agent of melioidosis. The bacterium has been shown to induce the innate immune response, particularly pro-inflammatory cytokine production in several of both mouse and human cell types. In the present study, we investigate host immune r...

    journal_title:Medical microbiology and immunology

    pub_type: 杂志文章


    authors: Kulsantiwong P,Pudla M,Boondit J,Wikraiphat C,Dunachie SJ,Chantratita N,Utaisincharoen P

    更新日期:2016-06-01 00:00:00

  • Phosphorylcholine is located in Aggregatibacter actinomycetemcomitans fimbrial protein Flp 1.

    abstract::Phosphorylcholine (ChoP) is covalently incorporated into bacterial surface structures, contributing to host mimicry and promoting adhesion to surfaces. Our aims were to determine the frequency of ChoP display among Aggregatibacter actinomycetemcomitans strains, to clarify which surface structures bear ChoP, and whethe...

    journal_title:Medical microbiology and immunology

    pub_type: 杂志文章


    authors: Ihalin R,Zhong D,Karched M,Chen C,Asikainen S

    更新日期:2018-11-01 00:00:00

  • Internalization of human rhinovirus 14 into HeLa and ICAM-1-transfected BHK cells.

    abstract::Virus adsorption and uptake of human rhinovirus 14 (HRV14) were studied with HeLa cells and baby hamster kidney (BHK) cells which were transfected with the HRV14 receptor intercellular adhesion molecule-1 (ICAM-1). Transmission electron microscopy of HeLa cells revealed that HRV14 was internalized via clathrin-coated ...

    journal_title:Medical microbiology and immunology

    pub_type: 杂志文章


    authors: Grunert HP,Wolf KU,Langner KD,Sawitzky D,Habermehl KO,Zeichhardt H

    更新日期:1997-06-01 00:00:00

  • Envelope and nucleocapsid antigens of Cytomegalovirus (CMV).

    abstract::A method for the purification and concentration of Cytomegalovirus nucleocapsids and particles complete with envelope is described. Antibody to either nucleocapsid or envelope antigens can be detected in human sera. In patients with CMV disease the antibodies to the envelope antigen could not be detected before the 3r...

    journal_title:Medical microbiology and immunology

    pub_type: 杂志文章


    authors: Schmitz H,Doerr HW,Obrig M

    更新日期:1975-07-02 00:00:00

  • Demonstration of Borna disease virus-specific RNA in secretions of naturally infected horses by the polymerase chain reaction.

    abstract::The presence of Borna disease virus (BDV)-specific RNA was traced by the reverse transcriptase-polymerase chain reaction in conjunctival fluid, nasal secretions and saliva of horses which were seropositive but did not have any history of clinical Borna disease. Positive reactions encompassed sequences encoding the p24...

    journal_title:Medical microbiology and immunology

    pub_type: 杂志文章


    authors: Richt JA,Herzog S,Haberzettl K,Rott R

    更新日期:1993-12-01 00:00:00

  • Differentiation of Borrelia burgdorferi sensu lato strains using class I lysyl-tRNA synthetase-encoding genes.

    abstract::The essential protein lysyl-tRNA synthetase (LysRS) exists in two unrelated forms, a class I and a class II-type aminoacyl-tRNA synthetase. Comparative genome sequence analysis revealed that Borrelia burgdorferi sensu lato, the etiological agent of Lyme disease, contains a class I-type LysRS, whereas its tick and mamm...

    journal_title:Medical microbiology and immunology

    pub_type: 杂志文章


    authors: Mejlhede N,Monthán A,Theisen M,Ibba M

    更新日期:2003-05-01 00:00:00

  • Alternative Quantiferon cytokines for diagnosis of children with active tuberculosis and HIV co-infection in Ghana.

    abstract::IFN-γ release assays (IGRAs) often present false-negative or indeterminate results in children with tuberculosis. HIV co-infection may contribute to decreased sensitivity of IGRAs by impairing T-cell IFN-γ expression. Measurement of alternative cytokines in QuantiFERON® (QFT) supernatants can circumvent the IFN-γ-depe...

    journal_title:Medical microbiology and immunology

    pub_type: 杂志文章


    authors: Lundtoft C,Awuah AA,Nausch N,Enimil A,Mayatepek E,Owusu-Dabo E,Jacobsen M

    更新日期:2017-06-01 00:00:00

  • Interspecies transmission of Enterozytozoon bieneusi supported by observations in laboratory animals and phylogeny.

    abstract::Enterocytozoon bieneusi is emerging as an important cause of chronic diarrhoea in AIDS patients. Its reservoirs and transmission patterns are unknown. In this study, we have examined E. bieneusi sequences from four Rhesus macaques of different origin, which were kept at one animal facility. The sequences were identica...

    journal_title:Medical microbiology and immunology

    pub_type: 杂志文章


    authors: Drosten C,Laabs J,Kuhn EM,Schottelius J

    更新日期:2005-08-01 00:00:00