Fujifilm SILVAMP TB-LAM for the Diagnosis of Tuberculosis in Nigerian Adults

There is a need for diagnostics for tuberculosis (TB) that are easy to use, able to screen non-sputum samples, and able to provide rapid results for the management of both immunocompromised and immunocompetent individuals. The Fujifilm SILVAMP TB LAM (FujiLAM) assay, a new non-sputum based point of need test for the diagnosis of TB, could potentially address most of these needs. We evaluated the performance of FujiLAM in HIV positive and HIV negative patients with presumptive TB attending three district hospitals in Nigeria. Consecutive patients were asked to provide urine samples on the spot, which were tested with FujiLAM. The results were compared against a positive culture and/or Xpert MTB/RIF as the reference standard. Forty-five patients had bacteriologically confirmed TB, and 159 had negative culture and Xpert MTB/RIF (no TB). The FujiLAM test was positive in 23 (sensitivity 65.7%, 95% CI = 48–80) HIV negative and seven (70%, 95% CI = 35–92) HIV positive patients with bacteriological confirmation of TB. FujiLAM was negative in 97 (specificity 99.0%, 95% CI = 94–100) HIV negative and 56 (93.3%, 95% CI = 83–98) HIV positive patients without TB. The FujiLAM test has good diagnostic accuracy for considering its application in both HIV positive and HIV negative patients with TB.

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Diagnostic accuracy of a novel point-of-care urine lipoarabinomannan assay for the detection of tuberculosis among adult outpatients in Zambia: a prospective cross-sectional study

European Respiratory Journal ◽

10.1183/13993003.03999-2020 ◽

2021 ◽

pp. 2003999

Author(s):

Monde Muyoyeta ◽

Andrew D. Kerkhoff ◽

Lophina Chilukutu ◽

Emmanuel Moreau ◽

Samuel G. Schumacher ◽

...

Keyword(s):

Diagnostic Accuracy ◽

Point Of Care ◽

High Sensitivity ◽

Cross Sectional Study ◽

Hiv Positive ◽

Smear Microscopy ◽

Reference Standard ◽

Cross Sectional ◽

Pulmonary Tb ◽

Hiv Negative

BackgroundA novel, rapid, point-of-care urine-based lipoarabinomannan assay (Fujifilm SILVAMP TB-LAM, “FujiLAM”) has previously demonstrated substantially higher sensitivity for tuberculosis (TB) compared to the commercially-available Determine TB-LAM assay using bio-banked specimens. However, FujiLAM has not been prospectively evaluated using fresh urine specimens. Therefore, we determined the diagnostic accuracy of FujiLAM among HIV-positive and HIV-negative outpatients with presumptive TB in Zambia.MethodsAdult (≥18 years) presumptive TB patients presenting to two outpatient public health facilities in Lusaka, were included. All patients submitted sputa samples for smear-microscopy, Xpert Ultra and Mycobacterial culture and urine samples for the FujiLAM assay. Microbiologically-confirmed TB was defined by the detection of Mycobacterium tuberculosis in sputum using culture; this served as the reference standard to assess the diagnostic accuracy of FujiLAM.Results151 adults with paired sputum microbiologic tests and urine FujiLAM results were included; 45% were HIV-positive. Overall, 34/151 (23%) patients had culture-confirmed pulmonary TB. The overall sensitivity and specificity of FujiLAM was 77% (95% CI: 59–89) and 92% (95% CI: 86–96), respectively. FujiLAM's sensitivity among HIV-positive patients was 75% (95% CI: 43–95) compared to 75% (95% CI: 51–91) among HIV-negative patients. The sensitivity of FujiLAM in patients with smear-positive, confirmed pulmonary TB was 87% (95% CI: 60–98) compared to 68% (95%: 43–87) among patients with smear-negative, confirmed pulmonary TB.ConclusionsFujiLAM demonstrated high sensitivity for the detection of TB among both HIV-positive and HIV-negative adults and also demonstrated good specificity despite the lack of systematic extra-pulmonary sampling to inform a comprehensive microbiological reference standard.

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Tuberculosis diagnostic accuracy of stool Xpert MTB/RIF and urine AlereLAM in vulnerable children

European Respiratory Journal ◽

10.1183/13993003.01116-2021 ◽

2021 ◽

pp. 2101116

Author(s):

Patrick Orikiriza ◽

Julianna Smith ◽

Bob Ssekyanzi ◽

Dan Nyehangane ◽

Ivan Mugisha Taremwa ◽

...

Keyword(s):

Diagnostic Accuracy ◽

Sensitivity And Specificity ◽

Severe Malnutrition ◽

Hiv Positive ◽

Age Group ◽

Reference Standard ◽

Hiv Status ◽

Vulnerable Children ◽

Diagnostic Approaches ◽

Composite Reference Standard

BackgroundNon-sputum based diagnostic approaches are crucial in children at high risk of disseminated tuberculosis [TB] who cannot expectorate sputum. We evaluated the diagnostic accuracy of Xpert MTB/RIF from stool and urine AlereLipoarabinomannan [LAM] test in this group of children.MethodsHospitalised children with presumptive TB and either age <2 years, HIV-positive or severe malnutrition were enrolled in a diagnostic cohort. At enrolment, we attempted to collect two urine, two stool and two respiratory samples. Urine and stool were tested with AlereLAM and Xpert MTB/RIF, respectively. Respiratory samples were tested with Xpert MTB/RIF and mycobacterial culture. Both a microbiological and a composite clinical reference standard were used.ResultsThe study enrolled 219 children; median age 16.4 months, 72 (32.9%) HIV-positive and 184 (84.4%) severely malnourished. Twelve (5.5%) and 58 (28.5%) children had confirmed and unconfirmed TB respectively. Stool and urine were collected in 219 (100%) and 216 (98.6%) children. Against the microbiological reference standard the sensitivity and specificity (n/N, 95% confidence intervals) of stool Xpert MTB/RIF was 50.0% (6/12, 21.1–78.9) and 99.1% (198/200 96.4–99.9), while that of urine AlereLAM was 50.0% (6/12, 21.1–78.9) and 74.6% (147/197, 67.9–80.5) respectively. Against the composite reference standard sensitivity was reduced to 11.4% (8/70) for stool and 26.2% (17/68) for urine, with no major difference by age group (<2 and >2 years) or HIV status.ConclusionThe Xpert MTB/RIF assay has excellent specificity on stool, but sensitivity is suboptimal. Urine AlereLAM is compromised by poor sensitivity and specificity in children.

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Validation of the BD FACSPresto system for the measurement of CD4 T-lymphocytes and hemoglobin concentration in HIV-negative and HIV-positive subjects

Scientific Reports ◽

10.1038/s41598-020-76549-6 ◽

2020 ◽

Vol 10 (1) ◽

Author(s):

Xiaofan Lu ◽

Hanxiao Sun ◽

Haicong Li ◽

Wei Xia ◽

Hao Wu ◽

...

Keyword(s):

Point Of Care ◽

Venous Blood ◽

Method Comparison ◽

Hemoglobin Concentration ◽

Hiv Positive ◽

Reference Standard ◽

Blood Samples ◽

Deming Regression ◽

Hematology Analyzer ◽

Hiv Negative

Abstract This study aimed to compare the performance of the BD FACSPresto system with the conventional standard-of-care technologies for the measurement of absolute CD4 count (AbsCD4), CD4 percentage (CD4%) and total hemoglobin concentration (Hb) in capillary and venous blood samples of HIV-negative and HIV-positive subjects. A total of 1304 participants were included in this prospective cohort study. Both venous and capillary blood samples were analyzed using the BD FACSPresto system and the results were compared against the BD FACSCalibur for enumerating AbsCD4 and CD4% and Sysmex XT-4000i hematology analyzer for determining Hb levels. Method comparison studies were performed using Deming regression and Bland–Altman plots. The Deming regression analyses comparing the accuracy of the BD FACSPresto system with the reference standard technologies demonstrated a significant linear correlation between the AbsCD4, CD4%, and Hb values generated by the two platforms. The 95% CI of the slopes for AbsCD4, CD4%, and Hb levels were 0.94–0.99, 0.99–1.01 and 0.86–0.93, respectively (P < 0.001). Bland–Altman plots for AbsCD4, CD4%, and Hb levels demonstrated close agreement between the BD FACSPresto system and the reference standards for all study participants. The performance and accuracy of BD FACSPresto system was comparable to the reference standard technologies. The BD FACSPresto system can be used interchangeably with BD FACSCalibur platform for CD4 and Sysmex XT-4000i hematology analyzer for Hb concentrations in resource-limited settings thus, improving accessibility to point-of-care testing services.

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Prevalence of chlamydia among HIV positive and HIV negative patients in the Vhembe District as detected by real time PCR from urine samples

BMC Research Notes ◽

10.1186/s13104-016-1887-8 ◽

2016 ◽

Vol 9 (1) ◽

Cited By ~ 2

Author(s):

Tshepo Malesela Mafokwane ◽

Amidou Samie

Keyword(s):

Real Time ◽

Real Time Pcr ◽

Urine Samples ◽

Hiv Positive ◽

Vhembe District ◽

Hiv Negative

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Diagnostic Accuracy of the Xpert MTB/Rif Ultra for tuberculosis adenitis

10.21203/rs.2.13145/v1 ◽

2019 ◽

Author(s):

Katherine Antel ◽

Jenna Oosthuizen ◽

Francois Malherbe ◽

Vernon J Louw ◽

Mark P Nicol ◽

...

Keyword(s):

Lymph Node ◽

Diagnostic Accuracy ◽

Needle Biopsy ◽

High Specificity ◽

Hiv Positive ◽

Reference Standard ◽

Fine Needle Aspirates ◽

Tissue Specimens ◽

Culture Positive ◽

Composite Reference Standard

Abstract Background The WHO recently recommended the new Xpert MTB/RIF Ultra assay (Ultra) instead of the Xpert MTB/RIF assay because Ultra has improved sensitivity. We report the diagnostic accuracy of Ultra for tuberculous adenitis in a tuberculosis and HIV endemic setting.Methods We obtained fine-needle aspirates (FNA) and lymph node tissue by core-needle biopsy in adult patients with peripheral lymphadenopathy of > 20 mm. Ultra and mycobacterial culture were performed on FNA and tissue specimens, with histological examination of tissue specimens. We assessed the diagnostic accuracy of Ultra against a composite reference standard (CRS) of ‘definite tuberculosis’ (presence of acid-fast bacilli (AFBs) or culture positive on FNA or lymph node tissue) or ‘probable tuberculosis’ (macroscopic caseation or granulomas on histology or tuberculosis proven from another site, and no other identified cause for lymphadenopathy).Results We prospectively evaluated 99 participants of whom 50 were HIV positive: 21 had ‘definite tuberculosis’, 15 ‘probable tuberculosis’ and 63 did not have tuberculosis (of whom 38% had lymphoma and 19% disseminated malignancy). Using the CRS, the sensitivity of Ultra on FNA was 70% (95% CI 51-85) and on tissue was 67% (95% CI 45-84); specificity on FNA was 100% (95% CI 92-100) and on tissue 96% (95% CI 88-99).Conclusions Ultra performed on FNA or tissue of a lymph node had reasonable sensitivity and high specificity. Ultra on FNA would be an appropriate initial investigation for lymphadenopathy in tuberculosis endemic areas.

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Does counselling improve uptake of long-term and permanent contraceptive methods in a high HIV-prevalence setting?

African Journal of Primary Health Care & Family Medicine ◽

10.4102/phcfm.v7i1.779 ◽

2015 ◽

Vol 7 (1) ◽

Cited By ~ 2

Author(s):

Amon Siveregi ◽

Lilian Dudley ◽

Courage Makumucha ◽

Phatisizwe Dlamini ◽

Sihle Moyo ◽

...

Keyword(s):

Unmet Needs ◽

Post Partum ◽

Hiv Positive ◽

Contraceptive Methods ◽

Childbearing Age ◽

Hiv Positive Mothers ◽

District Hospitals ◽

Future Fertility ◽

Hiv Negative

Background: Studies have shown a reduced uptake of contraceptive methods in HIV-positive women of childbearing age, mainly because of unmet needs that may be a result of poor promotion of available methods of contraception, especially long-term and permanent methods (LTPM).Aim: To compare the uptake of contraceptive methods, and particularly LTPM, by HIV-positive and HIV negative post-partum mothers, and to assess the effects of counselling on contraceptive choices.Setting: Three government district hospitals in Swaziland.Methods: Interviews were conducted using a structured questionnaire, before and after counselling HIV negativeand HIV-positive post-partum women in LTPM use, unintended pregnancy rates, future fertility and reasons for contraceptive choices.Results: A total of 711 women, of whom half were HIV-positive, participated in the study. Most (72.3% HIV-negative and 84% HIV-positive) were on modern methods of contraception, with the majority using 2-monthly and 3-monthly injectables. Intended use of any contraceptive increased to 99% after counselling. LTPM use was 7.0% in HIV-negative mothers and 15.3% in HIV-positive mothers before counselling, compared with 41.3% and 42.4% in HIV-negative and HIV-positive mothers, respectively, after counselling. Pregnancy intentions and counselling on future fertility were significantly associated with current use of contraception, whilst current LTPM use and level of education were significantly associated with LTPM post-counselling.Conclusion: Counselling on all methods including LTPM reduced unmet needs in contraception in HIV positive and HIV-negative mothers and could improve contraceptive uptake and reduce unintended pregnancies. Health workers do not always remember to include LTPM when they counsel clients, which could result in a low uptake of these methods. Further experimental studies should be conducted to validate these results.

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Diagnostic Accuracy of a Novel and Rapid Lipoarabinomannan Test for Diagnosing Tuberculosis Among People With Human Immunodeficiency Virus

Open Forum Infectious Diseases ◽

10.1093/ofid/ofz530 ◽

2019 ◽

Vol 7 (1) ◽

Cited By ~ 9

Author(s):

Stephanie Bjerrum ◽

Tobias Broger ◽

Rita Székely ◽

Satoshi Mitarai ◽

Japheth A Opintan ◽

...

Keyword(s):

Human Immunodeficiency Virus ◽

Antiretroviral Therapy ◽

Diagnostic Accuracy ◽

Cumulative Risk ◽

Urine Samples ◽

The Novel ◽

Reference Standard ◽

Risk Of Mortality ◽

Immunodeficiency Virus ◽

Composite Reference Standard

Abstract Background The novel Fujifilm SILVAMP TB-LAM (FujiLAM) assay detects mycobacterial lipoarabinomannan in urine and has demonstrated superior sensitivity to the Alere Determine TB-LAM Ag (AlereLAM) assay for detection of tuberculosis among hospitalized people with human immunodeficiency virus (PWH). This is the first study to evaluate the assay among a broad population referred for antiretroviral therapy including both outpatients (mainly) and inpatients. Methods We assessed diagnostic accuracy of FujiLAM and AlereLAM assays in biobanked urine samples from a cohort of adults referred for antiretroviral therapy in Ghana against a microbiological and a composite (including clinical judgement) reference standard, and we assessed the association of FujiLAM test positivity with mortality. Results We evaluated urine samples from 532 PWH (462 outpatients, 70 inpatients). Against a microbiological reference standard, the sensitivity of FujiLAM was 74.2% (95% confidence interval [CI], 62.0–84.2) compared to 53.0% (95% CI, 40.3–65.4) for AlereLAM, a difference of 21.2% (CI, 13.1–32.5). Specificity was 89.3% (95% CI, 85.8–92.2) versus 95.6% (95% CI, 93.0–97.4) for FujiLAM and AlereLAM, a difference of −6.3% (95% CI −9.6 to −3.3). Specificity estimates for FujiLAM increased markedly to 98.8% (95% CI, 96.6–99.8) in patients with CD4 >100 cells/µL and when using a composite reference standard. FujiLAM test positivity was associated with increased cumulative risk of mortality at 6 months (hazard ratio, 4.80; 95% CI, 3.01–7.64). Conclusions FujiLAM offers significantly increased diagnostic sensitivity in comparison to AlereLAM. Specificity estimates for FujiLAM were lower than for AlereLAM but were affected by the limited ability of the reference standard to correctly diagnose tuberculosis in individuals with low CD4 counts.

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Incidence of Cytological Abnormalities in Pap's Smear in HIV Positive Women

Journal of Medical Research and Innovation ◽

10.15419/jmri.136 ◽

2018 ◽

Vol 2 (S1) ◽

pp. e000136

Author(s):

Suhana Jotva ◽

Hemani Desai ◽

Hansa Goswami

Keyword(s):

Trichomonas Vaginalis ◽

Clinical History ◽

Hiv Positive ◽

Squamous Intraepithelial Lesions ◽

Squamous Cells ◽

Medical College ◽

Hiv Positive Women ◽

Cytological Abnormalities ◽

Intraepithelial Lesions ◽

Hiv Negative

Aims and Objectives: The aim of present study is to estimate the frequency of abnormal PAP’s smears and mainly to detect precancerous and cancerous lesions as well as inflammatory lesions in HIV infected women. Methodology: Our study was a retrospective study of total 130 cases and PAP’s smears were examined in cytology section in Department of Pathology, BJ Medical College, Ahmedabad from 1st March 2017 to 31st August 2017. Both HIV positive and HIV negative patients were included in the study. 80 patients were HIV negative and 50 patients were HIV positive. The clinical history and relevant parameters were noted. All the smears were processed by a conventional method using Papanicolaou stain. Results: Out of 130 cases, 118 cases were reported negative for intraepithelial lesions or malignancy (NILM). Five cases were positive for squamous intraepithelial lesions (SIL) out of which four were HIV positive. Seven cases were of atypical squamous cells of undetermined significance (ASCUS) out of which 5 were HIV positive. Three cases were showing bacterial vaginosis. 1 case was showing Trichomonas Vaginalis. 19 cases were showing changes of non-specific inflammation. 6 cases were showing atrophic changes. Conclusion: HIV infected women are at more risk to develop cervical cytological abnormalities. The study revealed a maximum number of non-specific inflammatory smears followed by smears showing atrophic changes. Smears suspicious for malignancy (ASCUS) and smears showing squamous intraepithelial lesions (SIL) were more common in HIV positive patients. Thus regular PAP’s smears screening as recommended by National AIDS Control Organization (NACO) will help in early detection of cervical abnormalities in HIV positive women.

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