Journal Article > ReviewFull Text
Curr Opin HIV AIDS. 2017 May 1; Volume 12 (Issue 3); DOI:10.1097/COH.0000000000000370
Easterbrook PJ, Roberts TR, Sands A, Peeling RW
Curr Opin HIV AIDS. 2017 May 1; Volume 12 (Issue 3); DOI:10.1097/COH.0000000000000370
Journal Article > ResearchFull Text
PLOS One. 2015 April 17; Volume 10 (Issue 4); DOI:10.1371/journal.pone.0122433
Kosack CS, de Kieviet W, Bayrak K, Milovic A, Page AL
PLOS One. 2015 April 17; Volume 10 (Issue 4); DOI:10.1371/journal.pone.0122433
Creatinine is a parameter that is required to monitor renal function and is important to follow in patients under treatment with potentially toxic renal drugs, such as the anti-HIV drug Tenofovir. A point of care instrument to measure creatinine would be useful for patients monitoring in resource-limited settings, where more instruments that are sophisticated are not available. The StatSensor Xpress Creatinine (Nova Biomedical Cooperation, Waltham, MA, USA) point of care analyzer was evaluated for its diagnostic performance in indicating drug therapy change. Creatinine was measured in parallel using the Nova StatSensor Xpress Creatinine analyzer and the Vitros 5,1FS (Ortho Clinical Diagnostics, Inc, Rochester, USA), which served as reference standard. The precision (i.e., repeatability and reproducibility) and accuracy of the StatSensor Xpress Creatinine analyzer were calculated using a panel of specimens with normal, low pathological and high pathological values. Two different Nova StatSensor Xpress Creatinine analyzers were used for the assessment of accuracy using repeated measurements. The coefficient of variation of the StatSensor Xpress Creatinine analyzers ranged from 2.3 to 5.9% for repeatability and from 4.2 to 9.0% for between-run reproducibility. The concordance correlation agreement was good except for high values (>600 µmol/L). The Bland-Altman analysis in high pathological specimens suggests that the Nova StatSensor Xpress Creatinine test tends to underestimate high creatinine values (i.e., >600 µmol/L). The Nova StatSensor Xpress Creatinine analyzers showed acceptable to good results in terms of repeatability, inter-device reproducibility and between-run reproducibility over time using quality control reagents. The analyzer was found sufficiently accurate for detecting pathological values in patients (age >10 year) and can be used with a moderate risk of misclassification.
Journal Article > ResearchFull Text
PLOS One. 2011 May 31; Volume 6 (Issue 5); DOI:10.1371/journal.pone.0020175
Bonnet MMB, Gagnidze L, Guerin PJ, Bonte L, Ramsay AR, et al.
PLOS One. 2011 May 31; Volume 6 (Issue 5); DOI:10.1371/journal.pone.0020175
Sputum microscopy is the only diagnostic for tuberculosis (TB) available at peripheral levels of health service in resource-poor countries. Its sensitivity is reduced in high HIV-prevalence settings. Sodium hypochlorite (NaOCl) specimen sedimentation prior microscopy and light-emitting diode (LED)-fluorescence microscopy (FM) can individually improve performance of microscopy. This study aimed to evaluate the performance of combined LED-FM and NaOCl sputum sedimentation for TB detection at peripheral level of health services.
Journal Article > ResearchFull Text
PLOS One. 2012 March 19; Volume 7 (Issue 3); DOI:10.1371/journal.pone.0033704
Kosack CS, Page AL, Van Hulsteijn LT, Lentjes EG
PLOS One. 2012 March 19; Volume 7 (Issue 3); DOI:10.1371/journal.pone.0033704
Thyroid-stimulating hormone (TSH) promotes expression of thyroid hormones which are essential for metabolism, growth, and development. Second-line drugs to treat tuberculosis (TB) can cause hypothyroidism by suppressing thyroid hormone synthesis. Therefore, TSH levels are routinely measured in TB patients receiving second-line drugs, and thyroxin treatment is initiated where indicated. However, standard TSH tests are technically demanding for many low-resource settings where TB is prevalent; a simple and inexpensive test is urgently needed.
Journal Article > ResearchAbstract
J Clin Microbiol. 2019 October 16
Ardizzoni E, Orikiriza P, Ssuuna C, Nyehangane D, Gumsboga M, et al.
J Clin Microbiol. 2019 October 16
Background: Xpert MTB/RIF (Xpert) and culture are the most reliable methods for tuberculosis diagnosis but are still poorly accessible in many low resource countries. We aimed to assess the effect of OMNIgene® SPUTUM (OM-S) and ethanol in preserving sputum for Xpert and OM-S for mycobacteria growth indicator tube (MGIT) testing over a period of 15 and 8 days respectively.
Methods: Sputum were collected from newly diagnosed smear-positive patients. For Xpert, pooled samples were split into 5 aliquots: 3 for Xpert on day 0, 7 and 15 days without additive and 2 with either OM-S or ethanol at day 15. For MGIT, 2 aliquots were tested without preservative and 2 with OM-S at 0 and 8 days.
Results: A total of 48 and 47 samples were included in the analysis for Xpert and culture. With Xpert, using Day 0 as reference, untreated samples stored for 7 and 15 days showed concordance of 45/46 (97.8%) and 46/48 (95.8%). For samples preserved with OM-S or ethanol for 15 days compared with untreated samples processed at day 0 or after 15 days, OM-S concordance was 46/48(95.8%) and 47/48(97.9%), while ethanol was 44/48 (91.7%) and 45/48 (93.8%). With MGIT, concordance between untreated and OM-S treated samples was 21/41(51.2%) at Day 0 and 21/44(47.7%) at day8.
Conclusions: Xpert equally detected TB in OM-S treated and untreated samples up to 15 days but showed slightly lower detection in ethanol treated samples. Among OM-S treated samples, MGIT positivity was significantly lower compared to untreated samples at both time-points.
Methods: Sputum were collected from newly diagnosed smear-positive patients. For Xpert, pooled samples were split into 5 aliquots: 3 for Xpert on day 0, 7 and 15 days without additive and 2 with either OM-S or ethanol at day 15. For MGIT, 2 aliquots were tested without preservative and 2 with OM-S at 0 and 8 days.
Results: A total of 48 and 47 samples were included in the analysis for Xpert and culture. With Xpert, using Day 0 as reference, untreated samples stored for 7 and 15 days showed concordance of 45/46 (97.8%) and 46/48 (95.8%). For samples preserved with OM-S or ethanol for 15 days compared with untreated samples processed at day 0 or after 15 days, OM-S concordance was 46/48(95.8%) and 47/48(97.9%), while ethanol was 44/48 (91.7%) and 45/48 (93.8%). With MGIT, concordance between untreated and OM-S treated samples was 21/41(51.2%) at Day 0 and 21/44(47.7%) at day8.
Conclusions: Xpert equally detected TB in OM-S treated and untreated samples up to 15 days but showed slightly lower detection in ethanol treated samples. Among OM-S treated samples, MGIT positivity was significantly lower compared to untreated samples at both time-points.
Conference Material > Abstract
Lissouba P, Huerga H, Rucker C
Epicentre Scientific Day Paris 2021. 2021 June 10
BACKGROUND
The novel point-of-care urine-based FujiLAM test is promising for diagnosis of tuberculosis. We assessed the diagnostic yield of FujiLAM in HIV patients and the feasibility of using the test.
METHODS
We conducted a prospective diagnostic study and a mixed-methods feasibility and acceptability study in 4 countries: Uganda, Kenya,
Mozambique and South Africa. The diagnostic study included 2 groups of ambulatory HIV-positive adults: 1) with TB symptoms, 2) with advanced HIV disease and no TB symptoms. Patients received FujiLAM and AlereLAM, Xpert MTB/RIF, culture and chest X-ray. The feasibility study included test’ users, key informants and patients who participated through standard questionnaires, individual interviews and group discussions.
RESULTS
We included 1117 patients in the diagnostic study: 712 with TB symptoms (Group 1) and 405 with advanced HIV disease and no TB
symptoms (Group 2). TB was confirmed in 9.2% (63/685) and 4.1% (16/395) in Group 1 and 2, respectively. FujiLAM diagnostic yield among patients with confirmed TB was 63.2% and 43.8% in Group 1 and 2, respectively. FujiLAM diagnostic yield by CD4 count was: 75.0% in CD4<200, 77.8% in CD4 200-349, 31.3% in CD4≥350 (Group 1) and 46.7% in CD4<200 (Group 2). Most of the test users (including lay health workers) found FujiLAM easy to perform. The main concern was the multiple timed steps involved. Invalid results were obtained if test cartridges were dropped or performed on blood stained or cloudy urine. Most patients viewed urine sampling
positively and easier than sputum provision.
CONCLUSIONS
FujiLAM detects TB in a high proportion of the HIV patients with confirmed TB who have symptoms of TB and low CD4 counts, and in
a considerable proportion of those asymptomatic. The test is easy to perform at point-of-care. Urine sampling is well accepted by patients. These results encourage the future use of the FujiLAM assay.
KEY MESSAGES: The novel urine-based FujiLAM is a useful and easy to use point-of care test for TB diagnosis in HIV-positive patients. Urine sampling is well accepted.
This abstract is not to be quoted for publication.
The novel point-of-care urine-based FujiLAM test is promising for diagnosis of tuberculosis. We assessed the diagnostic yield of FujiLAM in HIV patients and the feasibility of using the test.
METHODS
We conducted a prospective diagnostic study and a mixed-methods feasibility and acceptability study in 4 countries: Uganda, Kenya,
Mozambique and South Africa. The diagnostic study included 2 groups of ambulatory HIV-positive adults: 1) with TB symptoms, 2) with advanced HIV disease and no TB symptoms. Patients received FujiLAM and AlereLAM, Xpert MTB/RIF, culture and chest X-ray. The feasibility study included test’ users, key informants and patients who participated through standard questionnaires, individual interviews and group discussions.
RESULTS
We included 1117 patients in the diagnostic study: 712 with TB symptoms (Group 1) and 405 with advanced HIV disease and no TB
symptoms (Group 2). TB was confirmed in 9.2% (63/685) and 4.1% (16/395) in Group 1 and 2, respectively. FujiLAM diagnostic yield among patients with confirmed TB was 63.2% and 43.8% in Group 1 and 2, respectively. FujiLAM diagnostic yield by CD4 count was: 75.0% in CD4<200, 77.8% in CD4 200-349, 31.3% in CD4≥350 (Group 1) and 46.7% in CD4<200 (Group 2). Most of the test users (including lay health workers) found FujiLAM easy to perform. The main concern was the multiple timed steps involved. Invalid results were obtained if test cartridges were dropped or performed on blood stained or cloudy urine. Most patients viewed urine sampling
positively and easier than sputum provision.
CONCLUSIONS
FujiLAM detects TB in a high proportion of the HIV patients with confirmed TB who have symptoms of TB and low CD4 counts, and in
a considerable proportion of those asymptomatic. The test is easy to perform at point-of-care. Urine sampling is well accepted by patients. These results encourage the future use of the FujiLAM assay.
KEY MESSAGES: The novel urine-based FujiLAM is a useful and easy to use point-of care test for TB diagnosis in HIV-positive patients. Urine sampling is well accepted.
This abstract is not to be quoted for publication.
Journal Article > ResearchFull Text
J Microbiol Methods. 2009 May 7; Volume 78 (Issue 1); 107-108.; DOI:10.1016/j.mimet.2009.05.001
Martin AIC, Fissette K, Varaine FFV, Portaels F, Palomino JC
J Microbiol Methods. 2009 May 7; Volume 78 (Issue 1); 107-108.; DOI:10.1016/j.mimet.2009.05.001
We compared the sensitivity and time to detection of growth of Mycobacterium tuberculosis in the thin layer agar (TLA) compared to BACTEC MGIT960. The average time for growth of M. tuberculosis in TLA and BACTEC MGIT960 was 10.6 and 9.6 days, respectively. The sensitivity of detection of M. tuberculosis was 97.3% on TLA and 97% on BACTEC MGIT960 for smear positive samples. TLA showed comparable results to BACTEC MGIT960 and could be an alternative method for low-income countries.
Journal Article > ResearchFull Text
Trop Med Int Health. 2016 March 6; Volume 21 (Issue 5); 603-609.; DOI:10.1111/tmi.12688
Kosack CS, Nick S
Trop Med Int Health. 2016 March 6; Volume 21 (Issue 5); 603-609.; DOI:10.1111/tmi.12688
OBJECTIVE
To evaluate the diagnostic accuracy of the OraQuick HCV rapid antibody test from OraSure and the Multisure HCV antibody assay from MP Biomedicals.
METHODS
Five seropanels from patients, intravenous drug users and blood donors with and without HCV infection were used on the two rapid immunochromatographic tests. Sensitivity, specificity and predictive values were calculated. In addition, seropanels from 10 seroconverters were used to assess early identification of HCV infection. The study was undertaken in a laboratory at Paul Ehrlich Institute in Germany.
RESULTS
Panel 1 contained of 55 positive and 25 negative samples. The OraQuick HCV test had a sensitivity of 100% (95% CI: 93.5-100) and a specificity of 100% (95% CI: 86.3-100). The Multisure HCV test had a sensitivity of 100% (95% CI: 93.5-100) and a specificity of 96% (95% CI: 79.6-99.9). Panel 2 consisted of 193 pre-characterised anti-HCV-positive patient samples. The OraQuick HCV test identified 191 samples correctly and the Multisure HCV 192. The sensitivity was 99.0% (95% CI: 96.3-99.9) for the OraQuick HCV test and 99.5% (95% CI: 97.1-100) for the Multisure HCV test. Panel 3 was composed of seroconversion samples of 10 patients. The OraQuick HCV test detected all of these 10 infections while the Multisure HCV test detected six and was indeterminate on 2. Panel 4 included 53 anti-HCV negative blood samples from blood donors. Both tests correctly identified all 53. Panel 5 consisted of 26 samples of HCV/HIV co-infected patients. The sensitivity of the OraQuick HCV test was 65.2% (95% CI: 42.8-82.8) after 20 min and 73.9% (95% CI: 51.3-88.9) after 40 min of incubation. The Multisure HCV test had a sensitivity of 96.2% (95% CI: 80.4-99.9).
CONCLUSION
This evaluation revealed good sensitivity for both rapid screening assays. The detection of seroconverters, however, was lower in the MutiSure HCV test. Therefore the MultiSure test should be used with hesitation in high incidence settings. The OraQuick gave HCV false-negative results in almost 25% of the HIV-positive sera. Therefore may the OraQuick be less suited in HIV prevalent areas.
To evaluate the diagnostic accuracy of the OraQuick HCV rapid antibody test from OraSure and the Multisure HCV antibody assay from MP Biomedicals.
METHODS
Five seropanels from patients, intravenous drug users and blood donors with and without HCV infection were used on the two rapid immunochromatographic tests. Sensitivity, specificity and predictive values were calculated. In addition, seropanels from 10 seroconverters were used to assess early identification of HCV infection. The study was undertaken in a laboratory at Paul Ehrlich Institute in Germany.
RESULTS
Panel 1 contained of 55 positive and 25 negative samples. The OraQuick HCV test had a sensitivity of 100% (95% CI: 93.5-100) and a specificity of 100% (95% CI: 86.3-100). The Multisure HCV test had a sensitivity of 100% (95% CI: 93.5-100) and a specificity of 96% (95% CI: 79.6-99.9). Panel 2 consisted of 193 pre-characterised anti-HCV-positive patient samples. The OraQuick HCV test identified 191 samples correctly and the Multisure HCV 192. The sensitivity was 99.0% (95% CI: 96.3-99.9) for the OraQuick HCV test and 99.5% (95% CI: 97.1-100) for the Multisure HCV test. Panel 3 was composed of seroconversion samples of 10 patients. The OraQuick HCV test detected all of these 10 infections while the Multisure HCV test detected six and was indeterminate on 2. Panel 4 included 53 anti-HCV negative blood samples from blood donors. Both tests correctly identified all 53. Panel 5 consisted of 26 samples of HCV/HIV co-infected patients. The sensitivity of the OraQuick HCV test was 65.2% (95% CI: 42.8-82.8) after 20 min and 73.9% (95% CI: 51.3-88.9) after 40 min of incubation. The Multisure HCV test had a sensitivity of 96.2% (95% CI: 80.4-99.9).
CONCLUSION
This evaluation revealed good sensitivity for both rapid screening assays. The detection of seroconverters, however, was lower in the MutiSure HCV test. Therefore the MultiSure test should be used with hesitation in high incidence settings. The OraQuick gave HCV false-negative results in almost 25% of the HIV-positive sera. Therefore may the OraQuick be less suited in HIV prevalent areas.
Conference Material > Abstract
Taremwa IM
TB Research Dissemination Workshop, Epicentre Uganda. 2022 June 29
BACKGROUND
People with immunosuppression may be particularly vulnerable to SARS-CoV-2 and some symptoms of infection by SARS-CoV-2 and TB are similar. Dual infection with both TB and COVID-19 may also lead to poorer treatment outcomes. This study was nested into the FujiLAM study and assessed the prevalence of exposure and infection by SARS-CoV-2 among HIV patients investigated for TB.
METHODS
A prospective observational study including HIV-positive patients with symptoms of TB (group 1) and patients with advanced HIV disease and no symptoms of TB (group 2) in Uganda, Kenya, and South Africa. All patients were investigated for TB and were proposed SARS-CoV-2 antibody testing at the first and the 6-month consultation. SARS-CoV-2 PCR was proposed to patients with symptoms of TB at the first consultation and patients with symptoms of Covid-19 at any time during follow-up. Exposure to SARS-CoV-2 was defined by the detection of antibodies, while the infection was determined by PCR.
FINDINGS
In total, 1466 HIV-positive patients included in the FujiLAM study were investigated for SARS-CoV-2 (985 patients in group 1 and, 481 patients in group 2). Of these, 1254 (85.5%) patients consented to SARS-CoV-2 antibody testing (829 in group 1 and 425 in group 2), and 1188 (94.7%) of them had results. Overall, 27.9% (331/1188) of patients had a positive serology result. According to the CD4 count, a positive serology result was found in 22.3% (110/443) of patients with CD4<200, and 31.7% (213/671) of those with CD4>200, p<0.001. Among patients with symptoms of TB who accepted PCR testing, 8.3% (40/483) had PCR positive results, of whom, 12.5% (5/40) had confirmed TB. Finally, among the 40 patients that were PCR positive, 15 (35.7%) were started on TB treatment.
INTERPRETATIONS
This study reports moderate to high exposure to Covid-19 among patients investigated for TB. Also, it reveals that HIV-positive with CD4<200 have lower Covid-19 serology positivity than those with CD4≥200. This finding may have implications regarding the level of protection for immunosuppressed HIV-positive patients who have passed the disease or for vaccination strategy. Indeed, people living with HIV and with a low levels of CD4 should be prioritized for COVID-19 vaccination. Moreover, a considerable proportion of Covid-19 infected patients were also diagnosed with TB.
These abstracts are not to be quoted for publication
People with immunosuppression may be particularly vulnerable to SARS-CoV-2 and some symptoms of infection by SARS-CoV-2 and TB are similar. Dual infection with both TB and COVID-19 may also lead to poorer treatment outcomes. This study was nested into the FujiLAM study and assessed the prevalence of exposure and infection by SARS-CoV-2 among HIV patients investigated for TB.
METHODS
A prospective observational study including HIV-positive patients with symptoms of TB (group 1) and patients with advanced HIV disease and no symptoms of TB (group 2) in Uganda, Kenya, and South Africa. All patients were investigated for TB and were proposed SARS-CoV-2 antibody testing at the first and the 6-month consultation. SARS-CoV-2 PCR was proposed to patients with symptoms of TB at the first consultation and patients with symptoms of Covid-19 at any time during follow-up. Exposure to SARS-CoV-2 was defined by the detection of antibodies, while the infection was determined by PCR.
FINDINGS
In total, 1466 HIV-positive patients included in the FujiLAM study were investigated for SARS-CoV-2 (985 patients in group 1 and, 481 patients in group 2). Of these, 1254 (85.5%) patients consented to SARS-CoV-2 antibody testing (829 in group 1 and 425 in group 2), and 1188 (94.7%) of them had results. Overall, 27.9% (331/1188) of patients had a positive serology result. According to the CD4 count, a positive serology result was found in 22.3% (110/443) of patients with CD4<200, and 31.7% (213/671) of those with CD4>200, p<0.001. Among patients with symptoms of TB who accepted PCR testing, 8.3% (40/483) had PCR positive results, of whom, 12.5% (5/40) had confirmed TB. Finally, among the 40 patients that were PCR positive, 15 (35.7%) were started on TB treatment.
INTERPRETATIONS
This study reports moderate to high exposure to Covid-19 among patients investigated for TB. Also, it reveals that HIV-positive with CD4<200 have lower Covid-19 serology positivity than those with CD4≥200. This finding may have implications regarding the level of protection for immunosuppressed HIV-positive patients who have passed the disease or for vaccination strategy. Indeed, people living with HIV and with a low levels of CD4 should be prioritized for COVID-19 vaccination. Moreover, a considerable proportion of Covid-19 infected patients were also diagnosed with TB.
These abstracts are not to be quoted for publication
Journal Article > ResearchFull Text
PLOS One. 2010 June 11; Volume 5 (Issue 6); DOI:10.1371/journal.pone.0011086
Rose AMC, Mueller JE, Gerstl S, Njanpop-Lafourcade BM, Page AL, et al.
PLOS One. 2010 June 11; Volume 5 (Issue 6); DOI:10.1371/journal.pone.0011086
Meningococcal meningitis outbreaks occur every year during the dry season in the "meningitis belt" of sub-Saharan Africa. Identification of the causative strain is crucial before launching mass vaccination campaigns, to assure use of the correct vaccine. Rapid agglutination (latex) tests are most commonly available in district-level laboratories at the beginning of the epidemic season; limitations include a short shelf-life and the need for refrigeration and good technical skills. Recently, a new dipstick rapid diagnostic test (RDT) was developed to identify and differentiate disease caused by meningococcal serogroups A, W135, C and Y. We evaluated the diagnostic performance of this dipstick RDT during an urban outbreak of meningitis caused by N. meningitidis serogroup A in Ouagadougou, Burkina Faso; first against an in-country reference standard of culture and/or multiplex PCR; and second against culture and/or a highly sensitive nested PCR technique performed in Oslo, Norway. We included 267 patients with suspected acute bacterial meningitis. Using the in-country reference standard, 50 samples (19%) were positive. Dipstick RDT sensitivity (N = 265) was 70% (95%CI 55-82) and specificity 97% (95%CI 93-99). Using culture and/or nested PCR, 126/259 (49%) samples were positive; dipstick RDT sensitivity (N = 257) was 32% (95%CI 24-41), and specificity was 99% (95%CI 95-100). We found dipstick RDT sensitivity lower than values reported from (i) assessments under ideal laboratory conditions (>90%), and (ii) a prior field evaluation in Niger [89% (95%CI 80-95)]. Specificity, however, was similar to (i), and higher than (ii) [62% (95%CI 48-75)]. At this stage in development, therefore, other tests (e.g., latex) might be preferred for use in peripheral health centres. We highlight the value of field evaluations for new diagnostic tests, and note relatively low sensitivity of a reference standard using multiplex vs. nested PCR. Although the former is the current standard for bacterial meningitis surveillance in the meningitis belt, nested PCR performed in a certified laboratory should be used as an absolute reference when evaluating new diagnostic tests.