Displaying publications 21 - 40 of 67 in total

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  1. Fulltext EGFR mutation testing practices within the Asia Pacific region: results of a multicenter diagnostic survey
    Yatabe Y, Kerr KM, Utomo A, Rajadurai P, Tran VK, Du X, et al.
    J Thorac Oncol, 2015 Mar;10(3):438-45.
    PMID: 25376513 DOI: 10.1097/JTO.0000000000000422
    The efficacy of epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors in EGFR mutation-positive non-small-cell lung cancer (NSCLC) patients necessitates accurate, timely testing. Although EGFR mutation testing has been adopted by many laboratories in Asia, data are lacking on the proportion of NSCLC patients tested in each country, and the most commonly used testing methods.
    Matched MeSH terms: Reagent Kits, Diagnostic
  2. Fulltext Early diagnosis of Dengue infection using a commercial Dengue Duo rapid test kit for the detection of NS1, IGM, and IGG
    Wang SM, Sekaran SD
    Am J Trop Med Hyg, 2010 Sep;83(3):690-5.
    PMID: 20810840 DOI: 10.4269/ajtmh.2010.10-0117
    A commercial Dengue Duo rapid test kit was evaluated for early dengue diagnosis by detection of dengue virus NS1 antigen and immunoglobulin M (IgM)/IgG antibodies. A total of 420 patient serum samples were subjected to real-time reverse transcription-polymerase chain reaction (RT-PCR), in-house IgM capture enzyme-linked immunosorbent assay (ELISA), hemagglutination inhibition assay, and the SD Dengue Duo rapid test. Of the 320 dengue acute and convalescent sera, dengue infection was detected by either serology or RT-PCR in 300 samples (93.75%), as compared with 289 samples (90.31%) in the combined SD Duo NS1/IgM. The NS1 detection rate is inversely proportional, whereas the IgM detection rate is directly proportional to the presence of IgG antibodies. The sensitivity and specificity in diagnosing acute dengue infection in the SD Duo NS1/IgM were 88.65% and 98.75%, respectively. The assay is sensitive and highly specific. Detection of both NS1 and IgM by SD Duo gave comparable detection rate by either serology or RT-PCR.
    Matched MeSH terms: Reagent Kits, Diagnostic*
  3. Fulltext Effect of hemoglobin E on glycosylated hemoglobin determinations using different commercial kits
    Musalmah M, Normah J, Wan Mohamad WB, Salwah ON, Fatah HA, Nik Zahari NA
    Med J Malaysia, 2000 Sep;55(3):352-6.
    PMID: 11200716
    The effect of HbE, a hemoglobin variant, on the determination of HbA1/HbA1c using 4 commercial kits based on cation-exchange resin, cation-exchange column chromatography and specific antibody techniques was studied. Fifty-eight normal and 63 HbE heterozygous subjects were tested for HbA1 and HbA1c using 4 commercial kits i.e. Eagles Diagnostics, Boehringer Mannehim (BM), Diastat and Ames DCA 2000. Analyses of the samples by the 4 kits were done within one week and samples were stored at 4 degrees C before analysis. The results showed that HbE affects the determination of glycosylated hemoglobin using cation-exchange based and not kits based on specific antibody techniques.
    Matched MeSH terms: Reagent Kits, Diagnostic*
  4. Fulltext Evaluating the sensitivity of a commercial dengue NS1 antigen-capture ELISA for early diagnosis of acute dengue virus infection
    Kumarasamy V, Chua SK, Hassan Z, Wahab AH, Chem YK, Mohamad M, et al.
    Singapore Med J, 2007 Jul;48(7):669-73.
    PMID: 17609831
    INTRODUCTION: The aim of this report is to establish an accurate diagnosis of acute dengue virus infection early, in order to provide timely information for the management of patients and early public health control of dengue outbreak.
    METHODS: 224 serum samples from patients with a clinical diagnosis of acute dengue infection, which were subsequently confirmed by laboratory tests, were used to evaluate the performance of a commercially-available dengue NS1 antigen-capture ELISA kit.
    RESULTS: The dengue NS1 antigen-capture ELISA gave an overall sensitivity rate of 93.3 percent (209/224). The sensitivity rate was significantly higher in acute primary dengue (97.4 percent) than in acute secondary dengue (68.8 percent). In comparison, the virus isolation gave an overall positive isolation rate of 64.7 percent, with a positive rate of 70.8 percent and 28.1 percent, for acute primary dengue and acute secondary dengue, respectively. Molecular detection of dengue RNA by RT-PCR gave an overall positive detection rate of 63.4 percent, with a positive rate of 62.5 percent and 68.8 percent, for acute primary dengue and acute secondary dengue, respectively. Of the 224 acute serum samples from patients with laboratory-confirmed acute dengue infection, dengue IgM was detected in 88 specimens, comprising 68 acute primary dengue specimens and 20 acute secondary dengue specimens. NS1 antigen-capture ELISA kit gave an overall sensitivity rate of 88.6 percent in the presence of anti-dengue IgM and 96.3 percent in the absence of anti-dengue IgM.
    CONCLUSION: Of the 224 acute serum samples, the sample ages of 166 acute serum samples are known. The positive detection rate of dengue NS1 antigen-capture ELISA, on the whole, was higher than the other three established diagnostic test methods for laboratory diagnosis of acute dengue infection.
    Matched MeSH terms: Reagent Kits, Diagnostic
  5. Evaluation of BV(®) Blue Test Kit for the diagnosis of bacterial vaginosis
    Kampan NC, Suffian SS, Ithnin NS, Muhammad M, Zakaria SZ, Jamil MA
    Sex Reprod Healthc, 2011 Jan;2(1):1-5.
    PMID: 21147452 DOI: 10.1016/j.srhc.2010.11.002
    The aim of this study is to determine the sensitivity, specificity and the predictive value of the BV(®) Blue Test Kit in the diagnosis of bacterial vaginosis and to observe the risk factors associated with bacterial vaginosis (BV) in the study population. A prospective, cross-sectional study on 151 non-pregnant women who presented or referred to HUKM with presence of vaginal discharge, abnormal vaginal odour, pruritus vulvae of lower genital tract or incidental finding of abnormal PV discharge on pelvic examination. Samples of vaginal discharge were tested for bacterial vaginosis infection using Amsel's criteria, BV(®) Blue test and Gram stain (Nugent's score). Gram stain interpretation was made blinded without knowledge of other test result. Using Gram stain's criteria as a gold standard, the sensitivity, specificity, positive and negative predictive value of BV(®) Blue test and each of Amsel's criteria were estimated. The use of vaginal douches increased the risk of BV. The risk of BV with vaginal douching was 2.8 (95% CI 1.0-7.8) compared to never users. BV(®) Blue test showed a sensitivity of 100.0%, specificity of 98.3%, positive predictive value (PPV) of 94.4% and negative predictive value (NPV) of 100.0% compared to Gram stain (Nugent's method). BV(®) Blue test had excellent agreement with Gram stain which was 98.7%. BV(®) Blue test is a simple, rapid and reliable test allowing immediate diagnosis and prompt treatment of BV in the absence of microscopy which would greatly benefit majority of women at the greatest risk of sequel of bacterial vaginosis.
    Matched MeSH terms: Reagent Kits, Diagnostic*
  6. Fulltext Evaluation of WHO monoclonal antibody kit for diagnosis of acute respiratory viral infections
    Khairullah NS, Lam SK
    Southeast Asian J. Trop. Med. Public Health, 1995 Jun;26(2):263-7.
    PMID: 8629057
    In 1990 and 1991, six laboratories located in the WHO Western Pacific Region (WPR) and South East Asian Region (SEAR) were selected, based on their experience in the immunofluorescence antibody technique (IFAT), to participate in the evaluation of a WHO monoclonal antibody (Mab) kit to detect respiratory syncytial (RS) virus, influenza A virus, influenza B virus, parainfluenza virus and adenovirus. Despite differences in the initial standardization procedures, the WHO monoclonal antibodies were found to be of high quality, sensitivity and specificity when tested on clinical specimens. The constant supply of affordable high quality reagents from WHO would enable their use in clinical virological laboratories in the developing countries as well as promote the utilization of IFAT as an adjunct to cell culture isolation in the diagnosis of acute respiratory viral infections.
    Matched MeSH terms: Reagent Kits, Diagnostic/standards*
  7. Fulltext Evaluation of a Commercial Immuno-Chromatographic Assay Kit for Rapid Detection of IgM Antibodies against Leptospira Antigen in Human Serum
    Amran F, Liow YL, Halim NAN
    J Korean Med Sci, 2018 Apr 23;33(17):e131.
    PMID: 29686599 DOI: 10.3346/jkms.2018.33.e131
    Leptospirosis is a febrile zoonotic disease. Routine diagnosis of leptospirosis is based on the detection of specific antibodies with serological tests. The aim of our study was to determine the usefulness of immunochromatographic assay (ICA), ImmuneMed Leptospira IgM Duo Rapid test kit from Korea, in rapid screening of acute leptospirosis in emergency cases with limited expertise. A total of 197 serum samples (93 positive, 104 negative) were selected randomly. The test has good diagnostic sensitivity 73% and specificity 90%. With positive predictive value of 87% and negative predictive value of 79%, this reassures patients have higher chance of correct diagnosis. This ICA is acceptable for screening of leptospirosis but confirmation with microscopic agglutination test should follow.
    Matched MeSH terms: Reagent Kits, Diagnostic*
  8. Evaluation of a capture screening enzyme-linked immunosorbent assay for combined determination of immunoglobulin M and G antibodies produced during Dengue infection
    Kit Lam S, Lan Ew C, Mitchell JL, Cuzzubbo AJ, Devine PL
    Clin Diagn Lab Immunol, 2000 Sep;7(5):850-2.
    PMID: 10973469
    A commercially available enzyme-linked immunosorbent assay (ELISA) (PanBio Dengue Screening ELISA) that utilized both immunoglobulin M (IgM) and IgG capture in the same microtiter well for the diagnosis of dengue infection was evaluated. Sensitivity in primary and secondary dengue was 95%, while specificity was 94%.
    Matched MeSH terms: Reagent Kits, Diagnostic
  9. Fulltext Evaluation of a commercial dengue NS1 antigen-capture ELISA for laboratory diagnosis of acute dengue virus infection
    Kumarasamy V, Wahab AH, Chua SK, Hassan Z, Chem YK, Mohamad M, et al.
    J Virol Methods, 2007 Mar;140(1-2):75-9.
    PMID: 17140671
    A commercial dengue NS1 antigen-capture ELISA was evaluated to demonstrate its potential application for early laboratory diagnosis of acute dengue virus infection. Dengue virus NS1 antigen was detected in 199 of 213 acute serum samples from patients with laboratory confirmation of acute dengue virus infection but none of the 354 healthy blood donors' serum specimens. The dengue NS1 antigen-capture ELISA gave an overall sensitivity of 93.4% (199/213) and a specificity of 100% (354/354). The sensitivity was significantly higher in acute primary dengue (97.3%) than in acute secondary dengue (70.0%). The positive predictive value of the dengue NS1 antigen-capture ELISA was 100% and negative predictive value was 97.3%. Comparatively, virus isolation gave an overall positive isolation rate of 68.1% with a positive isolation rate of 73.9 and 31.0% for acute primary dengue and acute secondary dengue, respectively. Molecular detection of dengue RNA by RT-PCR gave an overall positive detection rate of 66.7% with a detection rate of 65.2 and 75.9% for acute primary dengue and acute secondary dengue, respectively. The results indicate that the commercial dengue NS1 antigen-capture ELISA may be superior to virus isolation and RT-PCR for the laboratory diagnosis of acute dengue infection based on a single serum sample.
    Matched MeSH terms: Reagent Kits, Diagnostic*
  10. Fulltext Evaluation of a urinary metanephrines reagent kit: an automated approach
    Thevarajah MT, Nadarajah S, Chew YY, Chan PC
    Singapore Med J, 2008 Jun;49(6):454-7.
    PMID: 18581016
    We report the results of a laboratory evaluation of the BioRad Urinary Metanephrines Reagent Kit. The test was designed for the quantitative measurement of normetanephrine and metanephrine in urine by high performance liquid chromatography. The kit was evaluated in view of improving assay reliability and specificity as compared to the manual method based on cation exchange chromatography and spectrophotometry.
    Matched MeSH terms: Reagent Kits, Diagnostic*
  11. Evaluation of capture ELISA and rapid immunochromatographic test for the determination of IgM and IgG antibodies produced during dengue infection
    Lam SK, Devine PL
    Clin Diagn Virol, 1998 May 1;10(1):75-81.
    PMID: 9646004
    Rapid diagnosis of dengue infection is essential to patient management and disease control. The development of a rapid (5 min) immunochromatographic test and a 2 h commercial capture enzyme linked immunosorbent assay (ELISA) for anti-dengue IgM and IgG antibodies may lead to more rapid and accurate testing in peripheral health settings and diagnostic laboratories.
    Matched MeSH terms: Reagent Kits, Diagnostic
  12. Fulltext Evaluation of commercially available diagnostic tests for the detection of dengue virus NS1 antigen and anti-dengue virus IgM antibody
    Hunsperger EA, Yoksan S, Buchy P, Nguyen VC, Sekaran SD, Enria DA, et al.
    PLoS Negl Trop Dis, 2014 Oct;8(10):e3171.
    PMID: 25330157 DOI: 10.1371/journal.pntd.0003171
    Commercially available diagnostic test kits for detection of dengue virus (DENV) non-structural protein 1 (NS1) and anti-DENV IgM were evaluated for their sensitivity and specificity and other performance characteristics by a diagnostic laboratory network developed by World Health Organization (WHO), the UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR) and the Pediatric Dengue Vaccine Initiative (PDVI). Each network laboratory contributed characterized serum specimens for the panels used in the evaluation. Microplate enzyme-linked immunosorbent assay (ELISA) and rapid diagnostic test (RDT formats) were represented by the kits. Each ELISA was evaluated by 2 laboratories and RDTs were evaluated by at least 3 laboratories. The reference tests for IgM anti-DENV were laboratory developed assays produced by the Armed Forces Research Institute for Medical Science (AFRIMS) and the Centers for Disease Control and Prevention (CDC), and the NS1 reference test was reverse transcriptase polymerase chain reaction (RT-PCR). Results were analyzed to determine sensitivity, specificity, inter-laboratory and inter-reader agreement, lot-to-lot variation and ease-of-use. NS1 ELISA sensitivity was 60-75% and specificity 71-80%; NS1 RDT sensitivity was 38-71% and specificity 76-80%; the IgM anti-DENV RDTs sensitivity was 30-96%, with a specificity of 86-92%, and IgM anti-DENV ELISA sensitivity was 96-98% and specificity 78-91%. NS1 tests were generally more sensitive in specimens from the acute phase of dengue and in primary DENV infection, whereas IgM anti-DENV tests were less sensitive in secondary DENV infections. The reproducibility of the NS1 RDTs ranged from 92-99% and the IgM anti-DENV RDTs from 88-94%.
    Matched MeSH terms: Reagent Kits, Diagnostic*
  13. Fulltext Evaluation of extraction kits and RT-qPCR systems adapted to high-throughput platform for circulating miRNAs
    Tan GW, Khoo AS, Tan LP
    Sci Rep, 2015;5:9430.
    PMID: 25800946 DOI: 10.1038/srep09430
    MicroRNAs regulate gene expression at the post-transcriptional level. Differential expression of miRNAs can potentially be used as biomarkers for early diagnosis and prediction for outcomes. Failure in validation of miRNA profiles is often caused by variations in experimental parameters. In this study, the performance of five extraction kits and three RT-qPCR systems were evaluated using BioMark high-throughput platform and the effects of different experimental parameters on circulating miRNA levels were determined. Differences in the performance of extraction kits as well as varying accuracy, sensitivity and reproducibility in qPCR systems were observed. Normalisation of RT-qPCR data to spike-in controls can reduce extraction bias. However, the extent of correlation for different qPCR systems varies in different assays. At different time points, there was no significant fold change in eight of the plasma miRNAs that we evaluated. Higher level of miRNAs was detected in plasma as compared to serum of the same cohort. In summary, we demonstrated that high-throughput RT-qPCR with pre-amplification step had increased sensitivity and can be achieved with accuracy and high reproducibility through stringent experimental controls. The information provided here is useful for planning biomarker validation studies involving circulating miRNAs.
    Matched MeSH terms: Reagent Kits, Diagnostic
  14. Fulltext Evaluation of the Elecsys(®) Anti-HCV II assay for routine hepatitis C virus screening of different Asian Pacific populations and detection of early infection
    Yoo SJ, Wang LL, Ning HC, Tao CM, Hirankarn N, Kuakarn S, et al.
    J Clin Virol, 2015 Mar;64:20-7.
    PMID: 25728074 DOI: 10.1016/j.jcv.2014.12.015
    Early diagnosis of hepatitis C virus (HCV) infection is essential to allow appropriate treatment and prevent transmission.
    Matched MeSH terms: Reagent Kits, Diagnostic
  15. Fulltext Evaluation of two commercially available ELISAs for the diagnosis of Japanese encephalitis applied to field samples
    Lewthwaite P, Shankar MV, Tio PH, Daly J, Last A, Ravikumar R, et al.
    Trop Med Int Health, 2010 Jul;15(7):811-8.
    PMID: 20487425 DOI: 10.1111/j.1365-3156.2010.02537.x
    OBJECTIVE: To compare two commercially available kits, Japanese Encephalitis-Dengue IgM Combo ELISA (Panbio Diagnostics) and JEV-CheX IgM capture ELISA (XCyton Diagnostics Limited), to a reference standard (Universiti Malaysia Sarawak - Venture Technologies VT ELISA).

    METHODS: Samples were obtained from 172/192 children presenting to a site in rural India with acute encephalitis syndrome.

    RESULTS: Using the reference VT ELISA, infection with Japanese encephalitis virus (JEV) was confirmed in 44 (26%) patients, with central nervous system infection confirmed in 27 of these; seven patients were dengue seropositive. Of the 121 remaining patients, 37 (31%) were JEV negative and 84 (69%) were JEV unknown because timing of the last sample tested was <10 day of illness or unknown. For patient classification with XCyton, using cerebrospinal fluid alone (the recommended sample), sensitivity was 77.8% (59.2-89.4) with specificity of 97.3% (90.6-99.2). For Panbio ELISA, using serum alone (the recommended sample), sensitivity was 72.5% (57.2-83.9) with specificity of 97.5% (92.8-99.1). Using all available samples for patient classification, sensitivity and specificity were 63.6% (95% CI: 48.9-76.2) and 98.4% (94.5-99.6), respectively, for XCyton ELISA and 75.0% (59.3-85.4) and 97.7% (93.3-99.2) for Panbio ELISA.

    CONCLUSION: The two commercially available ELISAs had reasonable sensitivities and excellent specificities for diagnosing JEV.

    Matched MeSH terms: Reagent Kits, Diagnostic
  16. Field validation of sensitivity and specificity of rapid test for detection of Brugia malayi infection
    Jamail M, Andrew K, Junaidi D, Krishnan AK, Faizal M, Rahmah N
    Trop Med Int Health, 2005 Jan;10(1):99-104.
    PMID: 15655019
    We conducted a field study of a rapid test (Brugia Rapid) for detection of Brugia malayi infection to validate its sensitivity and specificity under operational conditions. Seven districts in the state of Sarawak, Malaysia, which are endemic for brugian filariasis, were used to determine the test sensitivity. Determination of specificity was performed in another state in Malaysia (Bachok, Kelantan) which is non-endemic for filariasis but endemic for soil-transmitted helminths. In Sarawak both the rapid test and thick blood smear preparation were performed in the field. The rapid test was interpreted on site, whereas blood smears were taken to the district health centres for staining and microscopic examination. Sensitivity of Brugia Rapid dipstick as compared with microscopy of thick blood smears was 87% (20/23; 95% CI: 66.4-97.2) whereas the specificity was 100% (512/512). The lower sensitivity of the test in the field than in laboratory evaluations (> or =95%), was probably due to the small number of microfilaraemic individuals, in addition to difficulties in performing the test in remote villages by field personnel. The overall prevalence of brugian filariasis as determined by the dipstick is 9.4% (95% CI: 8.2-0.5) while that determined by microscopy is 0.90% (95% CI: 0.5-1.3) thus the dipstick detected about 10 times more cases than microscopy. Equal percentages of adults and children were found to be positive by the dipstick whereas microscopy showed that the number of infected children was seven times less than infected adults. The rapid dipstick test was useful as a diagnostic tool for mapping and certification phases of the lymphatic filariasis elimination programme in B. malayi-endemic areas.
    Matched MeSH terms: Reagent Kits, Diagnostic
  17. Fulltext G6PD enzyme activity in normal term Malaysian neonates and adults using a OSMMR2000-D kit with Hb normalization
    Azma RZ, Hidayati N, Farisah NR, Hamidah NH, Ainoon O
    Southeast Asian J. Trop. Med. Public Health, 2010 Jul;41(4):982-8.
    PMID: 21073074
    Glucose-6-phosphate dehydrogenase (G6PD) deficiency is one of the commonest causes of neonatal jaundice in Malaysia. Screening of cord blood for G6PD deficiency by the semiquantitative fluorescent spot test (FST) is performed in Malaysia but this test can miss cases of partial G6PD deficiency. The OSMMR-D kit assay measures G6PD activity and hemoglobin (Hb) concentration, allowing direct expression of results in U/gHb. We evaluated this method and established the normal range for G6PD activity in normal term neonates and adults. EDTA blood from 94 neonates and 295 adults (age 15-59 years old) with normal Hb and FST were selected. The normal means for G6PD activity for neonates and adults were 12.43 +/- 2.28 U/gHb and 9.21 +/- 2.6 U/gHb, respectively; the reference ranges for normal G6PD activity in neonates and adults were 10.15-14.71 U/gHb and 6.61-11.81 U/gHb respectively. There were no significant differences in mean normal G6PD activity between the Malays and Chinese racial groups or between genders. The upper and lower limit cut-off points for partial deficiency in neonates were 7.4 U/gHb (60% of the normal mean) and 2.5 U/gHb (20% of the normal mean), respectively. For adults, the upper and lower limit cut-off points for partial deficiency in adults were 5.52 U/gHb (60% of the normal mean) and 1.84 U/gHb (20% of the normal mean), respectively. The quantitation of G6PD enzymes using this OSMMR-D kit with Hb normalization was simple since the Hb was analyzed simultaneously and the results were reproducible with a CV of less than 5%.
    Matched MeSH terms: Reagent Kits, Diagnostic*
  18. Fulltext Genomic DNA extraction from medicinal plants available in Malaysia using a TriOmic(TM) improved extraction kit
    Mohd-Hairul AR, Sade AB, Yiap BC, Raha AR
    Genet. Mol. Res., 2011;10(4):2757-64.
    PMID: 22095601 DOI: 10.4238/2011.November.8.1
    DNA extraction was carried out on 32 medicinal plant samples available in Malaysia using the TriOmic(TM) extraction kit. Amounts of 0.1 g flowers or young leaves were ground with liquid nitrogen, lysed at 65°C in RY1(plus) buffer and followed by RNAse treatment. Then, RY2 buffer was added to the samples and mixed completely by vortexing before removal of cell debris by centrifugation. Supernatants were transferred to fresh microcentrifuge tubes and 0.1 volume RY3 buffer was added to each of the transferred supernatant. The mixtures were applied to spin columns followed by a centrifugation step to remove buffers and other residues. Washing step was carried out twice by applying 70% ethanol to the spin columns. Genomic DNA of the samples was recovered by applying 50 μL TE buffer to the membrane of each spin column, followed by a centrifugation step at room temperature. A modification of the TriOmic(TM) extraction procedure was carried out by adding chloroform:isoamyl alcohol (24:1) steps in the extraction procedure. The genomic DNA extracted from most of the 32 samples showed an increase of total yield when chloroform:isoamyl alcohol (24:1) steps were applied in the TriOmicTM extraction procedure. This preliminary study is very important for molecular studies of medicinal plants available in Malaysia since the DNA extraction can be completed in a shorter period of time (within 1 h) compared to manual extraction, which entails applying phenol, chloroform and ethanol precipitation, and requires 1-2 days to complete.
    Matched MeSH terms: Reagent Kits, Diagnostic*
  19. HUITAI rapid urease test: a new ultra-rapid biopsy urease test for the diagnosis of Helicobacter pylori infection
    Goh KL, Cheah PL, Navaratnam P, Chin SC, Xiao SD
    J Dig Dis, 2007 Aug;8(3):139-42.
    PMID: 17650225
    The gastric biopsy urease test is an accurate and robust diagnostic test for Helicobacter pylori infection. Large endoscopy units use their own homemade unbuffered ultra-rapid urease test for diagnosis of H. pylori infection but several commercial rapid urease tests are available.
    Matched MeSH terms: Reagent Kits, Diagnostic/microbiology
  20. Fulltext Leptospirosis in Kuala Lumpur and the comparative evaluation of two rapid commercial diagnostic kits against the MAT test for the detection of antibodies to leptospira interrogans
    Sekhar WY, Soo EH, Gopalakrishnan V, Devi S
    Singapore Med J, 2000 Aug;41(8):370-5.
    PMID: 11256343
    The aim of the study was to look into the epidemiology of serodiagnosed cases of leptospirosis at the University Hospital and compare two commercial ELISA Assays to the Microscopic Agglutination Test (MAT). Demographic data for all serodiagnosed cases for the years 1991-1997 were collected. From this data, 104 sera (n = 104) were selected as samples for comparative evaluation of the commercial ELISAs (INDX Dip-S-Ticks and PanBio ELISA) to the MAT test. Thirty two (n = 32) negative control sera were selected from serodiagnosed cases of other differential diagnosis of leptospira infection. The MAT test is a standard test that detects agglutination antibodies to leptospira biflexa, while the INDX Dip-S-Ticks is an ELISA dot test assaying for total anti-leptospira antibodies. The PanBio ELISA is a colorometric assay in test well strips to detect anti-leptospira IgM. The sensitivity, specificity, and efficiency of tests were calculated at a MAT cut-off value of 1:320. Demographic data showed that leptospirosis peaks during March-May and Aug-Nov coinciding with the inter-monsoon period with more men being infected than women and more adults than children. The sensitivity, specificity, and efficiency of test for the INDX Dip-S-Ticks were 83.3%, 93.8% and 87.5% while the values for the PanBio ELISA were 54.2%, 96.9% and 71.3%. The suboptimal PanBio result could be related to the blocking effect of high IgG titres or could be related to the diagnostic MAT cut-off values used in this study. The data hence reflects a pattern of transmission that is related to "wet" occupational risk factors. The commercial assays evaluated, are easier to perform but interpretation of results should be based on level of endemicity. The INDX Dip-S-Ticks allows this flexibility and is a practical alternative to the MAT test.
    Matched MeSH terms: Reagent Kits, Diagnostic/standards*
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