Cost-effectiveness analysis and budgetary impact of the Cryptococcal Antigen Lateral Flow Assay (CRAG-LFA) implementation for the screening and diagnosis of cryptococcosis in asymptomatic people living with HIV in Brazil

Vianna, Cid Manso de Mello; Mosegui, Gabriela Bittencourt Gonzalez

doi:10.1590/s1678-9946202163057

Cited by 4 publications

(7 citation statements)

References 17 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…The presence of Cryptococcosis in the central nervous system leads to severe neurological complications [2,3,7,10]. In recent years, great advances have been described in development of laboratory techniques for the diagnosis of infectious diseases and in the emergence of new methodologies for the diagnosis of Cryptococcus spp., especially in HIV-positive individuals [21][22][23][24][25][26]28,[32][33][34][35][36]40,41]. However, the problem of early accurate diagnosis still remains.…”

Section: Discussionmentioning

confidence: 99%

“…Currently, the laboratory diagnosis of Cryptococcus spp. is based on mycological, histopathological and serological tests [17][18][19][20][21][22][23][24][25][26]. The Brazilian Unified Health System (SUS) provides different methods for the diagnosis of CM.…”

Section: Introductionmentioning

confidence: 99%

“…Culture is the gold standard for the diagnosis of Cryptococcus spp. [21][22][23][24][25]. According to Vidal et al (2018), detection of CrAg LFA in serum, CSF, and whole blood shows great sensitivity and specificity.…”

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Comparative analysis of diagnostic methods for the detection of Cryptococcus neoformans meningitis

Dantas

Freitas-Xavier

Lombardi³

et al. 2023

PLoS Negl Trop Dis

View full text Add to dashboard Cite

Background Cryptococcosis is a devastating opportunistic infection in immunocompromised individuals, primarily in people living with HIV/AIDS. This study evaluated a protocol for the early diagnosis of meningitis due to C. neoformans, utilizing established molecular techniques from serum and CSF samples. Methods The 18S and 5.8S (rDNA-ITS) sequence-specific nested PCR assays were compared with direct India ink staining and the latex agglutination test for detection of C. neoformans in serum and cerebrospinal fluid (CSF) from 49 Brazilian suspected meningitis patients. Results were validated with samples obtained from 10 patients negative for cryptococcosis and HIV, and by analysis of standard C. neoformans strains. Principal findings The 5.8S DNA-ITS PCR was more sensitive (89–100%) and specific (100%) than the 18S rDNA PCR and conventional tests (India ink staining and latex agglutination) for identification of C. neoformans. While the 18S PCR exhibited a sensitivity (72%) similar to that of the latex agglutination assay in serum samples, it was superior to the latex agglutination assay when testing CSF, with a sensitivity of 84%. However, the latex agglutination was superior to the 18SrDNA PCR in specificity in CSF (92%). The 5.8S DNA-ITS PCR yielded the highest levels of accuracy (96–100%) of any test for detection (serological and mycological) of C. neoformans in both serum and CSF. Conclusion Use of the nested 5.8S PCR was superior to other techniques for the diagnosis of cryptococcosis. The possibility of using serum, a non-invasively collected material, in a targeted 5.8S PCR analysis to identify Cryptococcus spp. is recommended, especially in immunosuppressed patients. Our results indicate that nested 5.8S PCR can increase the diagnostic capability of cryptococcosis, and we suggest its use to monitor patients in the future.

show abstract

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Comparative analysis of diagnostic methods for the detection of Cryptococcus neoformans meningitis

Dantas

Freitas-Xavier

Lombardi³

et al. 2023

PLoS Negl Trop Dis

View full text Add to dashboard Cite

show abstract

“…For patients with CD4 < 100 cells/µL, studies employing the CRAG-latex test have already demonstrated a 20-40% reduction in disease-associated mortality [51,52], preventing 43% of CM deaths even at a low prevalence of 1.4% [17]. In Brazil, a cost-effectiveness study based on the prevalence of 3.09% in HIV-infected patients with CD4 < 200 cells/µL showed that two cryptococcal antigen tests (CRAG-latex and LFA) are cost-effective in patients with CD4 < 200 cells/µL compared to India ink and no screening, with LFA proving superior to CRAG-latex, avoiding 15% of deaths by CM and decreasing costs by 11 million US dollars in five years [33]. Recently, the cryptococcal antigen lateral flow assay diagnostic test for the detection of Cryptococcus infection in PLHA was incorporated for use in the Unified Health System (SUS) by the Ministry of Health, for patients with CD4 < 200 cells/µL and for the diagnosis of CM in PLHA regardless of CD4+ cell count [53,54].…”

Section: Discussionmentioning

confidence: 99%

“…This strategy is largely cost-effective compared to inpatient treatment of CM, considering both the CRAG-latex [16,32] and LFA [17,19] diagnostic tests. In addition to the benefit of being a point-of-care test, in Brazil, the cost-benefit of LFA is even higher than the CRAG-latex in people living with HIV/AIDS (PLHA) with CD4 ≤ 200 cells/µL [33].…”

Section: Introductionmentioning

confidence: 99%

Prevalence and Associated Factors of Cryptococcal Antigenemia in HIV-Infected Patients with CD4 < 200 Cells/µL in São Paulo, Brazil: A Bayesian Analysis

Mimicos

Fossaluza²,

Picone³

et al. 2022

JoF

View full text Add to dashboard Cite

Cryptococcosis is a severe life-threatening disease and a major cause of mortality in people with advanced AIDS and CD4 ≤ 100 cells/µL. Considering the knowledge gap regarding the benefits of routine application of antigenemia tests in HIV-infected patients with 100–200 CD4 cells/µL for the prevention of cryptococcal meningitis (CM), we aimed to evaluate the prevalence of positive antigenemia through lateral flow assay (LFA) and associated factors in HIV-infected patients with CD4 < 200 cells/µL. Our findings of 3.49% of positive LFA (LFA+) patients with CD4 < 100 cells/µL and 2.24% with CD4 between 100–200 cells/µL have been included in a Bayesian analysis with 12 other studies containing similar samples worldwide. This analysis showed a proportion of 3.6% LFA+ patients (95% credible interval-Ci [2.5–5.7%]) with CD4 < 100 cells/µL and 1.1% (95%Ci [0.5–4.3%]) with CD4 between 100–200 cells/µL, without statistical difference between these groups. The difference between mortality rates in LFA+ and negative LFA groups was e = 0.05013. Cryptococcoma and CM were observed in the LFA+ group with 100–200 and <100 CD4 cells/µL, respectively. Considering the benefits of antifungal therapy for LFA+ patients, our data reinforced the recommendation to apply LFA as a routine test in patients with 100–200 CD4 cells/µL aiming to expand cost-effectiveness studies in this group.

show abstract

Assessment of an Antigen Lateral Flow Assay (LFA) For Point of Care Diagnosis of Cryptococcosis in SenegalAssessment of an Antigen Lateral Flow Assay (LFA) For Point of Care Diagnosis of Cryptococcosis in Senegal

2023

OAJMMS

View full text Add to dashboard Cite

Background: Cryptococcal meningitis is a medical emergency. Therefore, simple, rapid and efficient diagnostic techniques are needed. New rapid diagnostic tests based on the detection of cryptococcal antigen have been developed. The aim of our study was to evaluate the performance of the Dynamiker Cryptococcal Antigen Lateral Flow Assay (LFA) in our routine diagnosis activities. Materials and Methods: We performed a prospective study from November 2017 to August 2018 at the ParasitologyMycology laboratory of the CHNU of Fann in Dakar. Biological samples collected from HIV-infected patients hospitalized at the infectious diseases department of CHUN de Fann were used. Serum, CSF and urine samples received in the laboratory were examined using mycological techniques and the cryptococcal latex agglutination test (CLAT). The performance of the Dynamiker test was evaluated considering CLAT as the reference method. Results: A total of 39 samples were examined: 14 CSF, 24 sera and 1 urine sample. The average age was 44.5 years with a predominance of female patients (64.1%). The mean CD4 count was 73 cells/mm3 . Among the 39 samples tested, 23.1% were CLAT positive while 30.8% were LFA positive. The sensitivity and specificity rates were 100% and 75% respectively. The percentage of correlation between the two methods was 92.3%. The intensity of the bands on the LFA was high en 66.7% of cases. Conclusion: The excellent sensitivity of the rapid Cryptococcal Antigen Lateral Flow Assay and the rapidity of obtaining results (less than 15 minutes) make it suitable for routine diagnosis of cryptococcal meningitis.

show abstract

Cost-effectiveness analysis and budgetary impact of the Cryptococcal Antigen Lateral Flow Assay (CRAG-LFA) implementation for the screening and diagnosis of cryptococcosis in asymptomatic people living with HIV in Brazil

Abstract: This is an open-access article distributed under the terms of the Creative Commons Attribution License.

Cited by 4 publications

References 17 publications

Comparative analysis of diagnostic methods for the detection of Cryptococcus neoformans meningitis

Comparative analysis of diagnostic methods for the detection of Cryptococcus neoformans meningitis

Prevalence and Associated Factors of Cryptococcal Antigenemia in HIV-Infected Patients with CD4 < 200 Cells/µL in São Paulo, Brazil: A Bayesian Analysis

Assessment of an Antigen Lateral Flow Assay (LFA) For Point of Care Diagnosis of Cryptococcosis in SenegalAssessment of an Antigen Lateral Flow Assay (LFA) For Point of Care Diagnosis of Cryptococcosis in Senegal

Contact Info

Product

Resources

About