|
Samples in the major goal† | Analysis of performance | Diagnosis improvement | Comparisons | To distinguish acute and chronic phase of infection | Others | Year | Ref. |
|
AF | | | | To evaluate Se/Sp of a prenatal AF using PCR | — | To compare Se of PCR in AF according to intervals between amniocentesis and infection. To compare epidemiological parameters in children with positive and negative PCR results | — | To evaluate time of treatment and gestational age on CT diagnosis | 2001 | [5] |
AF | | | | — | To develop a duplex real-time PCR based on fluorescence resonance energy transfer to quantify parasite load and to determine assay sensitivity | To compare routine PCR and the lightcycler PCR | — | To correlate parasite load to ultrasonographic abnormalities. To correlate parasite load to the gestational age at the time of maternal infection | 2001 | [6] |
AF | | | | To evaluate Se/Sp of PCR and bioassay on AF | To combine PCR with mice inoculation to improve sensitivity | To compare Se/Sp between PCR and mouse inoculation. To compare prenatal and postnatal diagnosis | — | — | 2002 | [7] |
AF | | | | — | — | To compare T. gondii detection limit of 4 PCR methods in AF (conventional PCR, fluorescent PCR, real-time qPCR with SYBRGreen or with fluorescence energy transfer hybridization probe) | — | — | 2006 | [8] |
AF | | | | — | — | To compare different PCR methods (primers for B1, rDNA, and AF146527) | — | — | 2009 | [9] |
AF | | | | — | — | To compare 3 PCR assays for T. gondii detection in AF (commercial nested PCR and two laboratory-developed PCRs: conventional and real time) | — | — | 2012 | [10] |
AF | | | | To evaluate performance (Se, Sp, PPV, NPV, PLR, NLR and EF) of PCR in AF | — | To compare performance of 4 PCR methods for CT diagnosis in AF: nested multiplex, conventional, and real time | — | — | 2013 | [11] |
AF | | | | — | | To compare 3 PCR assays used for T. gondii infection diagnosis: P30-PCR, B1-PCR, and RE-PCR | — | To characterize the infecting T. gondii strains from the clinical specimen using B1 multicopy gene as target | 2013 | [12] |
AF | | | | To evaluate Se, Sp, PPV, NPV of PCR in AF to detect T. gondii infection | — | To compare Se of PCR performed at second or third trimester amniocentesis | — | To evaluate influence of treatment and timing of amniocenteses in PCR Se. To evaluate the outcome in infants with CT diagnosed by amniocenteses | 2015 | [13] |
AF | BL | | | To evaluate Se/Sp of different diagnosis methods in AF and P-CB | To combine two diagnosis methods to improve diagnosis | To compare Se/Sp of different diagnosis methods | — | — | 2002 | [14] |
AF | BL | | | — | To combine PCR with IgG avidity to improve CT diagnosis | — | — | — | 2011 | [15] |
AF | BL | | | — | — | — | — | To characterize T. gondii present in AF and M-PB by genotyping | 2012 | [16] |
AF | BL | | | — | — | — | — | To characterize atypical cases of T. gondii seroconversion (without IgM detection or with transient IgM levels) based on serology and PCR in AF | 2013 | [17] |
AF | BL | | | To determine Se/Sp of diverse diagnosis methods and samples (AF, CB, and PB) | — | To compare prenatal and birth samples. To compare different PCR methodologies and different samples | — | — | 2013 | [18] |
AF | BL | | | To verify the accuracy of the IgG avidity index to diagnose recent T. gondii infection | — | To compare IgG avidity index with PCR for T. gondii detection results in AF | — | To determine a cut-off value of IgG avidity to predict T. gondii DNA in AF | 2015 | [19] |
AF | BL | | | To evaluate Se/Sp of PCR on CT diagnosis in AF obtained at birth | — | To compare Se in AF from patients with negative and positive CT diagnosis. To compare postnatal serology and at birth AF regarding early diagnosis ability | — | — | 2015 | [20] |
AF | BL | | | — | To combine PCR and avidity IgG in order to improve performance diagnosis | To compare conventional ELISA and IgG avidity with PCR (genes B1 and P30) in BL and AF samples for early CT | To associate data of IgG anti-T. gondii titers, avidity index, and PCR to diagnose acute toxoplasmosis | — | 2017 | [21] |
AF | BL | | | — | — | Comparison of gestational age, parasite load, and positive IgM between symptomatic and asymptomatic groups | — | To correlate T. gondii load, gestational age of maternal infection, and IgM at birth to the signs and severity of CT | 2017 | [22] |
AF | BL | | | — | — | To compare PCR results for T. gondii in AF to the follow-up screen at birth | — | To describe T. gondii DNA detection in AF. To date maternal T. gondii infection | 2018 | [23] |
| BL | | | — | — | To compare results obtained in the IgG avidity test with those obtained in the IgM ELISA and AC/HS tests | To evaluate the usefulness of testing for IgG avidity to exclude acute infection | — | 2001 | [24] |
| BL | | | — | — | Comparison between IgM ELISA and VIDAS IgG avidity. Comparison between VIDAS IgG avidity test and TSp results (IgG, IgA, IgM, and IgE) | To differentiate recently acquired from distant infection using T. gondii IgG avidity (VIDAS kit) and TSp (IgG, IgA, IgM, and IgE) | — | 2002 | [25] |
| BL | | | — | — | Comparison between individual recombinant antigens, its homogeneous mixture, and whole-cell toxoplasma antigen to determine IgG avidity | To discriminate between acute and latent phases of T. gondii infection by using recombinant antigens for avidity assay | — | 2003 | [26] |
| BL | | | To evaluate Se/Sp for different AI thresholds | To define a new threshold to improve performance of avidity index for diagnosing chronic infection | — | To correlate time of infection with the avidity index in order to date infection | To evaluate if time and type of treatment influences the avidity index | 2004 | [27] |
| BL | | | — | — | To compare IgM/IgG ELISA with PCR results performed in blood sample | — | To evaluate PCR utility to detect recent T. gondii infection | 2004 | [28] |
| BL | | | — | — | — | To evaluate the ability of IgG-avidity to predict the risk of mother-to-child transmission of T. gondii in pregnant women IgG+/IgM+ | — | 2006 | [29] |
| BL | | | To evaluate Se, Sp, PPV, NPV of two commercial kits for acute toxoplasmosis designed to detect IgA and IgG avidity | To combine IgA and IgM tests to improve CT diagnosis | — | — | — | 2007 | [30] |
| BL | | | — | — | To compare VIDAS avidity test and nested-PCR assay results to confirm ongoing or recent T. gondii infection in the selected group of pregnant women | To detect an ongoing or recent T. gondii infection in pregnant during the first 16 GW by using VIDAS T. gondii specific IgG-avidity test and nested PCR | — | 2007 | [31] |
| BL | | | — | To improve CT diagnosis by comparison mother and child antibody subclasses (IgG1, IgG2, IgG3, and IgG4) | — | — | — | 2008 | [32] |
| BL | | | To evaluate Se/Sp of IgG and IgM ELISA tests with rGRA6 | — | The comparisons between ELISA GRA6 with ELISA VIDAS and ELISA euroimmun | To investigated rGRA6 potential to differentiate recently acquired infections to those acquired in the distant past | — | 2008 | [33] |
| BL | | | To evaluate Se/Sp of IgM detection in filter paper-embedded blood | To verify if filter paper-embedded blood can be used for IgM detection. To determine IgG titer and IgG avidity in M-PB embedded in a filter paper | — | — | — | 2009 | [34] |
| BL | | | To analyze Se/Sp of the ARCHITECT toxo IgG, IgM, and IgG avidity | — | To compare IgG and/or IgM results by ARCHITECT and 2 commercial techniques (AxSYM and VIDAS) | — | — | 2009 | [35] |
| BL | | | To evaluate the ROC curve analysis of vitros IgM assay values for potential discrimination of acute and chronic infections | — | To compare the vitros IgG and IgM assays to the Sabin–Feldman dye test. To compare vitros Tg IgM to IgM ISAGA | To evaluate a screening serological method to identify chronic and acute Tg infection | — | 2009 | [36] |
| BL | | | To evaluate Se, Sp, PPV, NPV of MEIA, ELFA, IFAT, and ELISA (IgM e IgA) for CT diagnosis | — | — | — | — | 2009 | [37] |
| BL | | | To determine Se, Sp, PPV, NPV of combined elecsys IgG and IgM system | — | To compare the new Roche Elecsys T. gondii IgG and IgM immunoassay with Sabin–Feldman dye test and immunosorbent agglutination assay-IgM | To discriminate acute and chronic infection using ROC analysis for Elecsys IgM values | To determine the best cut-off using ROC analysis | 2010 | [38] |
| BL | | | To evaluate performance of IgG avidity test based on recombinant GRA6 antigen to differentiate recently acquired and distant T. gondii infections | To develop an IgG avidity test based on recombinant GRA6 antigen | To compare ELISA to the euroimmun IgG avidity ELISA for exclusion of a recent Toxoplasma infection that occurred less than 4 months before | To evaluate IgG avidity based on rGRA6 assay ability to differentiate recently acquired and distant T. gondii infections in pregnant women | To determine the best parameters affecting the level of dissociation of antigen-antibody complex | 2010 | [39] |
| BL | | | — | — | To compare immunoenzymatic, chemiluminescence, and indirect immunofluorescence assay with immunoblot analysis | To assess the immunoassays’ abilities to diagnose seroconversion at its earliest stages | — | 2011 | [40] |
| BL | | | — | — | — | To evaluate IgG avidity for TC diagnosis in early pregnancy | — | 2011 | [41] |
| BL | | | — | To improve CT diagnosis by comparing mother and child antibody that target high-molecular-mass T. gondii antigens | — | — | To identify the best immunoblot bands of T. gondii antigens able to differentiate mother and child infection | 2012 | [42] |
| BL | | | — | To identify potential T. gondii immunogens using pregnant sera and applying immunoproteomics assays | — | — | — | 2012 | [43] |
| BL | | | To evaluate performance of LFIA for rapid screening of anti-T. gondii antibody in serum and saliva samples from pregnant women | Development of SAG2-LFIA, ROP2-LFIA, and SAG2 + ROP2-LFIA for rapid screening of anti-T. gondii ab in pregnant serum and saliva | To compare LFIA to commercial ELISA | Screening T. gondii IgM, IgG, and IgA avidity by SAG2 + ROP2-LFIA in order to detect recent or acute T. gondii infection | — | 2012 | [44] |
| BL | | | — | — | The comparisons between PCR targeting the B1 gene and ELISA (IgG and IgM results) assays | — | — | 2012 | [45] |
| BL | | | — | To determine the impact of additional maternal and/or N-CB serology on improving prenatal screening for CT | Comparison between prenatal and postnatal (M-PB and N-CB) serology | — | — | 2013 | [46] |
| BL | | | To evaluate performance of IgG/IgM ELISA based on rMEP | To develop IgG/IgM ELISA based on rMEP | To compare rMEP-ELISA to commercial ELISA kits | To differentiate acute from chronic infection using ELISA based on a rMEP | — | 2013 | [47] |
| BL | | | — | — | To compare EIA-IgG and FAT techniques in order to analyze equivocal or discordant results in routine IgG tests | — | To assess the usefulness of the WB as a confirmatory test to solve discordant results between EIA-IgG and FAT techniques | 2013 | [48] |
| BL | | | To determine Se, Sp, PPV, NPV of VIDAS, architect and liaison systems for diagnosing T. gondii IgM and IgG | — | To compare anti-T. gondii IgG, IgM, and IgG avidity measurements obtained with three automated systems: VIDAS, architect, and liaison systems | — | To correlate anti-T. gondii IgG avidity measurements between VIDAS and architect and also between VIDAS and liaison systems | 2013 | [49] |
| BL | | | — | — | To compare homemade WB with the commercial LDBIO II | — | To select the more valuable bands in a homemade WB that can be used as a confirmatory technique for discordant or equivocal results in EIA and FAT | 2014 | [50] |
| BL | | | To determine Se, Sp, PPV, NPV of avidity assay | — | To compare IgG avidity results with the IgM and IgG ELISA test in a single serum sample | To discriminate acute and chronic infection in a single serum sample using IgG avidity assay | — | 2014 | [51] |
| BL | | | To evaluate IgM and IgG ELISA Se/Sp based on PCR results | — | To compare immunological methods (ELISA IgM, IgG, and IgG avidity) to PCR based on 529 bp T. gondii DNA fragment | To investigate ELISA IgM and IgG-avidity and PCR results for detection of past or recent toxoplasmosis according to PCR results | — | 2014 | [52] |
| BL | | | To determine performance of CML, indirect ELISA-rROP2 and IFI for the detection of IgG anti-T. gondii | — | To compare the performance of ELISA-rROP2 to CML and IFI for detection of IgG anti-T. gondii. Comparisons between IgG anti-T. gondii levels obtained from different pregnant groups using ELISA-rROP2 assay | — | — | 2015 | [53] |
| BL | | | — | — | To compare VIDAS and architect avidity to determine the best method for estimating infection date | To estimate the date of infection | — | 2016 | [54] |
| BL | | | To evaluate Se, Sp, PPV, NPV, accuracy of IgM IFAT in predicting recent infection according to the GW | — | — | To diagnose acute or chronic T. gondii infection using IgM IFAT | — | 2016 | [55] |
| BL | | | To analyze AUC, Se, Sp of rP35a and rP22a to discriminate samples from not infected, typical-chronic, presumably acute, and recently chronic infections | Using bioinformatics tools to predict the highest epitopes density regions in P35 and P22 and expressed them for obtaining soluble proteins | To compare rP35a and rP22a performance to discriminate not infected, typical-chronic, presumably acute, and recently chronic infections | To assess the ability of both P35 and P22 antigens to differentiate T. gondii acute and chronic infection stages using indirect and avidity ELISA | — | 2017 | [56] |
| BL | | | — | — | To compare IgM ELISA and IgG avidity in pregnant women during the first trimester pregnancy | To determine the performance of the IgG avidity test in detecting anti-T. gondii antibodies in pregnant women (IgG+/IgM+) | — | 2017 | [57] |
| BL | | | — | — | To compare WB (LDBIO II) and automated assays (TGS TA, architect, vidasII, liaisonII, platelia, and Elecsys) concerning ability to detect early T. gondii seroconversion | — | To evaluated time required for anti T. gondii IgG detection by WB and 6 automated assays | 2017 | [58] |
| BL | | | To determine Se, Sp of IIF, ELISA and IgG avidity tests | — | To compare ELISA, IIF and IgG avidity for diagnosing acute toxoplasmosis using a single serum sample | To discriminate acute and chronic infection using IgG avidity test | To evaluate the frequency of IIF and ELISA positivity using different serum dilutions | 2017 | [59] |
| BL | | | To determine Se, Sp, PPV, NPV of IA assay based on latex particles | To develop IA assay based on LPC with T. gondii protein (P22Ag) to evaluate its ability of discrimination infected (chronic and acute) and noninfected control | To compare characteristics of LPC coupled with P22Ag and T. gondii homogenate. To compare the performance of LPC made of different compositions | To ruling out acute toxoplasmosis in pregnant women using IA based on LPC | — | 2017 | [60] |
| BL | | | To evaluate the accuracy, Se, Sp, PPV, NPV of IgA in diagnosis of acute toxoplasmosis in pregnant women | — | To analyze IgA and IgM antibody positivity rates compared to AC/HS and IgG avidity results in pregnant women | To evaluate the usefulness of IgA in diagnosis of acute toxoplasmosis in pregnant women | — | 2019 | [61] |
| BL | PL | | To evaluate Se/Sp of methods (PCR, mouse inoculation) in PL and (ISAGA IgM, WB) in N-PB | To combine methods for improving Se diagnosis (PCR + bioassay in PL) or (ISAGA + WB in N-PB) or (PCR + bioassay in PL + ISAGA + WB in N-PB) | — | — | To establish the relationship between maternal treatment and T. gondii detection in PL. To analyze T. gondii strains isolated in PL tissue | 2007 | [62] |
| BL | PL | | To evaluate Se, Sp, PPV, NPV of PL for CT diagnosis using PCR and mouse inoculation | To combine mouse inoculation and PCR to improve sensitivity | — | — | To determine if time of maternal treatment or maternal seroconversion is related with PL Se | 2010 | [63] |
AF | BL | PL | | To evaluate Se, Sp, PPV, NPV of neonatal diagnosis: T. gondii isolation (PL and CB) and immunological tests (IgA and IgM). To evaluate Se of prenatal diagnosis | To combine prenatal and postnatal diagnosis for improving Se | To compare Se of different diagnosis methods | — | To evaluate treatment effect on diagnosis | 2001 | [64] |
AF | BL | PL | | — | — | Comparison between two PCR methods for detecting T. gondii in AF, BL, and tissues | — | — | 2004 | [65] |
AF | BL | PL | | To evaluate Se, Sp, PPV, NPV of methods (PCR, mouse inoculation) in AF and PL according to gestational age | — | To compare PCR and mouse inoculation in AF according to gestational age | — | — | 2009 | [66] |
AF | BL | PL | | To determine predictive values of molecular diagnosis in AF, PL, and CB | — | — | — | To estimate CT risk based on molecular diagnosis | 2012 | [67] |
AF | BL | PL | | To determine Se/Sp of different diagnosis methods and samples (AF, PL CB, and PB) | — | To compare two PCR methods for T. gondii detection in AF, CB, and PB | — | — | 2015 | [68] |
| BL | | CL | — | To evaluate CL as an alternative biological sample for CT diagnosis | To compare CL and M-PB samples in the following parameters: IgM, IgG, and IgA levels; IgG avidity against T. gondii antigenic fractions | — | To evaluate the correlation of IgM, IgG, and IgA detection in CL and M-PB samples | 2015 | [69] |
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