Displaying publications 21 - 40 of 67 in total

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  1. Fulltext Diagnostic accuracy of reused Pronto Drytest and CLOtest in the detection of Helicobacter pylori infection
    Jamaludin S, Mustaffa N, Che Hamzah NA, Syed Abdul Aziz SH, Lee YY
    BMC Gastroenterol, 2015;15:101.
    PMID: 26264957 DOI: 10.1186/s12876-015-0332-0
    Unchanged substrate in a negative rapid urease test may be reused to detect Helicobacter pylori (H. pylori). This could potentially reduce costs and wastage in low prevalence and resource-poor settings. We thus aimed to investigate the diagnostic accuracy of reused Pronto Dry and CLOtest kits, comparing this to the use of new Pronto Dry test kits and histopathological evaluation of gastric mucosal biopsies.
    Matched MeSH terms: Reagent Kits, Diagnostic/standards*
  2. Specificity and sensitivity of a rapid dipstick test (Brugia Rapid) in the detection of Brugia malayi infection
    Rahmah N, Taniawati S, Shenoy RK, Lim BH, Kumaraswami V, Anuar AK, et al.
    Trans R Soc Trop Med Hyg, 2002 1 31;95(6):601-4.
    PMID: 11816429
    A total of 753 serum samples from 6 institutions in 3 countries (Malaysia, Indonesia and India) were used to evaluate an immunochromatographic rapid dipstick test, Brugia Rapid, for diagnosis of Brugia malayi infection. The samples comprised sera from 207 microfilaria-positive individuals and 546 individuals from filaria non-endemic areas. The latter consisted of 70 individuals with soil-transmitted helminth infections, 68 with other helminth infections, 238 with protozoan infections, 12 with bacterial and viral infections and 158 healthy individuals. The dipstick is prepared with a goat anti-mouse antibody control line and a B. malayi recombinant-antigen test line. First, the dipstick is dipped into a well containing diluted patient serum, thus allowing specific anti-filarial antibody in the serum to react with the recombinant antigen. Then the dipstick is placed into an adjacent well containing reconstituted anti-human IgG4-gold. After 10 min, development of 2 red-purplish lines denotes a positive result and one line indicates a negative reaction. The overall results of the evaluation showed 97% sensitivity, 99% specificity, 97% positive predictive value and 99% negative predictive value. Brugia Rapid is thus a promising diagnostic tool for detection of B. malayi infection, and would be especially useful for the brugian filariasis elimination programme.
    Matched MeSH terms: Reagent Kits, Diagnostic/standards*
  3. Application of the Serodia-HCV particle agglutination for the detection of antibodies to hepatitis C virus
    Ooi BG, Sinniah M, Ismail S, Baharuddin R
    Malays J Pathol, 1996 Dec;18(2):89-93.
    PMID: 10879228
    The Serodia-HCV Particle Agglutination (HCV-PA) for the detection of HCV antibodies was compared with the Enzyme Immunoassay Test (UBI HCV EIA) for possible in-house use. A total of 150 specimens were analysed using UBI HCV EIA and Serodia-HCV PA. Of these, 80 (53.3%) were both PA and EIA positive and 59 (39.3%) were negative by both techniques. Eleven sera (7.4%) were found to be EIA-positive but PA-negative. These 11 discordant sera were further tested by the LiaTek-HCV III Immunoassay (Organon Teknika). Ten were found to be line immunoassay negative and one was line immunoassay positive. Failure of the PA to detect the HCV positive serum meant that a small proportion of HCV antibody positives may be missed by the PA test. We conclude that (i) EIA should continue to be the first line screening test in our laboratory, (ii) PA with its 100% specificity could be a useful supplementary screen for all EIA-positive sera and finally (iii) line immunoassay could be used on sera to resolve discordant results in the EIA and PA assays.
    Matched MeSH terms: Reagent Kits, Diagnostic/standards*
  4. Comparison of two monoclonal antibody kits with cell culture isolation in the detection of respiratory virus antigens
    Khairullah NS
    Malays J Pathol, 1996 Jun;18(1):27-30.
    PMID: 10879221
    Two different preparations of monoclonal antibodies developed against respiratory viruses have been evaluated by the immunofluorescence antibody technique. The Chemicon monoclonal antibodies were found to be more efficient at picking up positive specimens with a high sensitivity and specificity than Imagen monoclonal antibodies. However, the overall concordance rate of the monoclonal antibodies was 92.3%-100%. Generally, when compared with cell culture isolation, the immunofluorescence antibody technique was found to be more sensitive. The high quality of the Chemicon monoclonal antibodies contribute to their value in providing definitive diagnosis, within a few hours of specimen collection, thus allowing early management of patients, their contacts and control of hospital infection.
    Matched MeSH terms: Reagent Kits, Diagnostic*
  5. Fulltext Reliability of two commercial serological kits for serodiagnosing Helicobacter pylori infection
    Uyub AM, Anuar AK, Aiyar S
    Southeast Asian J. Trop. Med. Public Health, 1994 Jun;25(2):316-20.
    PMID: 7855648
    Two commercial serological kits, Pylori-set (Orion Diagnostica, Finland) and Helico-G (Cambridge Biomedical Ltd, UK), and an in-house ELISA were evaluated with sera from 24 Helicobacter pylori-positive and 146 H. pylori-negative dyspeptic patients. Sensitivity, specificity, positive and negative predictive values of Pylori-set were lower than that of Helico-G and in-house ELISA. Helico-G was more sensitive (91.7%) than in-house ELISA (83.3%) and both had comparable negative predictive values of 98.3% and 97.3%, respectively. However, specificity (97.9%) and positive predictive value (86.9%) of an in-house ELISA were much higher than specificity (80.1%) and positive predictive value (43.1%) of Helico-G. Kappa index of agreement between the three serological tests (Pylori-set, Helico-G or in-house ELISA) and the presence of H. pylori in antral biopsies was very low (k = 0.13; z = 1.9; p > 0.05), moderate (k = 0.49; z = 7.1; p < 0.0001), or substantial (k = 0.82; z = 10.8; p < 0.0001), respectively. Overall, statistical evaluations demonstrated that both commercial kits were not as reliable as the in-house ELISA for serodiagnosing H. pylori infection.
    Matched MeSH terms: Reagent Kits, Diagnostic*
  6. Multi-laboratory evaluation of a scrub typhus diagnostic kit
    Kelly DJ, Wong PW, Gan E, Chye CT, Cowan D, Lewis GE
    Am J Trop Med Hyg, 1990 Sep;43(3):301-7.
    PMID: 2121057
    Scrub typhus is a major cause of febrile illness throughout the Asia-Pacific region. It is commonly undiagnosed, partly because of the lack of a simple, reliable diagnostic test which can be used in clinical laboratories. The indirect immunoperoxidase technique, configured into a test kit, was provided to technicians who were trained in its use. They used the kit during a 2 year field trial in their respective clinical hospital laboratories throughout Malaysia. In an evaluation using 1,722 consecutive sera tested in those laboratories, the kit was found to have a median sensitivity for IgG detection of 0.85 (range 0.33-0.95), a median specificity of 0.94 (range 0.88-1.00), reproducibility of 0.86, and efficiency of 0.92 when compared to the reference laboratory. In a proficiency survey in which 10 laboratories received 3 coded test samples, all but 2 laboratories had results within 1 dilution of the reference laboratory in quantitating specific IgG, whereas 7 laboratories were within 1 dilution in quantitating IgM. The shelf life of the kit was at least 1 year at 4 degrees C.
    Matched MeSH terms: Reagent Kits, Diagnostic/standards*
  7. Multicentre laboratory evaluation of Brugia Rapid dipstick test for detection of brugian filariasis
    Rahmah N, Shenoy RK, Nutman TB, Weiss N, Gilmour K, Maizels RM, et al.
    Trop Med Int Health, 2003 Oct;8(10):895-900.
    PMID: 14516300
    A multicentre evaluation of the Brugia Rapid dipstick test was performed using 1263 serum samples in four international laboratories, i.e. T.D. Medical College (TDMC, India), National Institutes of Health (NIH, USA), Swiss Tropical Institute (STI, Switzerland) and Leiden University Medical Centre (LUMC, Netherlands). In comparison with microscopy, the dipstick demonstrated sensitivities of 97.2% (70 of 72) at TDMC, 91.6% (175 of 191) at LUMC and 100% (six of six) at STI. Sera of chronic patients showed a positivity rate of 11.3% (19 of 168) and 61.2% (71of 116) at TDMC and LUMC, respectively. All 266 sera of non-endemic normals from STI, NIH and LUMC tested negative with the dipstick. At LUMC, sera of 'endemic normals' (amicrofilaraemics with no clinical disease) from an area with approximately 35% microfilaria positivity showed 60.8% positive results (31 of 51), thus demonstrating the likelihood of many cryptic infections occurring in this population. Specificities of the test with Onchocerca volvulus sera were 98.8% (80 of 81) and 100% (10 of 10) at the NIH and STI, respectively; while specificity with Loa loa sera at the NIH was 84.6% (44 of 52). At the STI, the dipstick test also demonstrated 100% specificity when tested with 75 sera from various protozoan and helminthic infections.
    Matched MeSH terms: Reagent Kits, Diagnostic/standards*
  8. Fulltext Comparison of DR. HPV Chip Kit with hybrid capture II assay for the detection of human papillomavirus in clinical samples: a preliminary study
    Rajan S, Shen TH, Santhanam J, Othman NH, Othman N, Hock TT
    Trop Biomed, 2007 Jun;24(1):17-22.
    PMID: 17568373
    Human papillomavirus (HPV) is well known as an etiological factor for the development of anogenital carcinomas. The aim of our study was to compare the performance of USFDA approved Hybrid II (HCII) Assay and recently introduced DR. HPV Chip Kit for the detection of HPV DNA in clinical cervical scrapings from 40 patients. HPV DNA testing was performed using the automated HCII Assay system and DR. HPV Chip Kit. Taking cytological results as gold standard, it was found that HCII was more sensitive (36.4%) than DR. HPV Chip Kit (18.2%) although specificity was 100% with the latter method. In addition, both these molecular methods had comparable negative and positive predictive values. It was concluded that both HCII and DR. HPV Chip Kit have comparable specificity. However, sensitivity for detection of HPV in clinical samples with HCII is almost double as compared to DR. HPV Chip Kit.
    Matched MeSH terms: Reagent Kits, Diagnostic*
  9. Fulltext Temperature related storage evaluation of an RT-PCR test kit for the detection of dengue infection in mosquitoes
    Ooi CP, Rohani A, Zamree I, Lee HL
    Trop Biomed, 2005 Jun;22(1):73-6.
    PMID: 16880757
    The rapid detection of dengue infection in mosquito vectors is important for early warning to forestall an outbreak. Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) provides a rapid method for dengue detection in man and mosquitoes. An RT-PCR kit developed by the Medical Entomology Unit, Institute for Medical Research to detect dengue infection in mosquitoes, was tested for its shelf life at 3 storage temperatures: room temperature, refrigerator and freezer. Test kits were tested once every 3 days for kits stored at room temperature, and once every week for those stored at refrigerator and freezer temperatures. The results showed that the test kit could only be stored above its recommended storage temperature of -20 degrees C for not more than 3 days. DNA 100 bp markers in the kits appeared to be stable at the tested temperatures and were usable up to the 20th day when stored at 2 degrees C and below.
    Matched MeSH terms: Reagent Kits, Diagnostic*
  10. 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*
  11. Diagnostic performance of COVID-19 serology assays
    Zainol Rashid Z, Othman SN, Abdul Samat MN, Ali UK, Wong KK
    Malays J Pathol, 2020 Apr;42(1):13-21.
    PMID: 32342927
    INTRODUCTION: The World Health Organization (WHO) declared COVID-19 outbreak as a world pandemic on 12th March 2020. Diagnosis of suspected cases is confirmed by nucleic acid assays with real-time PCR, using respiratory samples. Serology tests are comparatively easier to perform, but their utility may be limited by the performance and the fact that antibodies appear later during the disease course. We aimed to describe the performance data on serological assays for COVID-19.

    MATERIALS AND METHODS: A review of multiple reports and kit inserts on the diagnostic performance of rapid tests from various manufacturers that are commercially available were performed. Only preliminary data are available currently.

    RESULTS: From a total of nine rapid detection test (RDT) kits, three kits offer total antibody detection, while six kits offer combination SARS-CoV-2 IgM and IgG detection in two separate test lines. All kits are based on colloidal gold-labeled immunochromatography principle and one-step method with results obtained within 15 minutes, using whole blood, serum or plasma samples. The sensitivity for both IgM and IgG tests ranges between 72.7% and 100%, while specificity ranges between 98.7% to 100%. Two immunochromatography using nasopharyngeal or throat swab for detection of COVID-19 specific antigen are also reviewed.

    CONCLUSIONS: There is much to determine regarding the value of serological testing in COVID-19 diagnosis and monitoring. More comprehensive evaluations of their performance are rapidly underway. The use of serology methods requires appropriate interpretations of the results and understanding the strengths and limitations of such tests.

    Matched MeSH terms: Reagent Kits, Diagnostic/standards*
  12. 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*
  13. Serial testing of Malaysian health care workers with QuantiFERON®-TB Gold In-Tube
    Rafiza S, Rampal KG
    Int J Tuberc Lung Dis, 2012 Feb;16(2):163-8.
    PMID: 22236915 DOI: 10.5588/ijtld.11.0364
    BACKGROUND: Serial testing for tuberculosis (TB) exposure has been advocated among health care workers (HCWs) at risk of nosocomial infection.
    OBJECTIVE: To determine the incidence and factors associated with TB infection among selected HCWs in Malaysia and to determine interferon-gamma response in serial testing.
    DESIGN: A cohort of 769 HCWs were retested after 1 year using QuantiFERON®-TB Gold In-Tube. Incidence of TB infection was determined among HCWs who previously tested negative. Conversion and reversion rates using several definitions were explored.
    RESULTS: Incidence of TB infection was 9.9 per 100 workers per year (95%CI 7.9-12.3). Working in the Emergency Department (ED; RR 2.18, 95%CI 1.07-4.43) was significantly associated with risk of TB infection. Reversion and conversion occurred frequently, with 46.7% reversion among HCWs with baseline interferon-gamma (IFN-γ) levels of 0.35-0.70 international units (IU)/ml, and 23.8% conversion among HCWs with baseline IFN-γ levels of 0.20-0.34 IU/ml.
    CONCLUSIONS: TB infection control measures need to be strengthened, particularly in the ED, as the incidence of TB was high. Conversion and reversion rates in serial testing were high, and further studies are needed to facilitate its interpretation.
    Matched MeSH terms: Reagent Kits, Diagnostic*
  14. 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*
  15. 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
  16. Quantity and quality assessment of DNA extracted from saliva and blood
    Looi ML, Zakaria H, Osman J, Jamal R
    Clin. Lab., 2012;58(3-4):307-12.
    PMID: 22582505
    Saliva has been suggested as an attractive resource for evaluating physiological and pathological conditions in humans. This study aims to evaluate saliva sampling as an alternative to blood sampling for molecular testing.
    Matched MeSH terms: Reagent Kits, Diagnostic
  17. Fulltext Total 25-OH vitamin D concentrations in Chinese, Malays and Indians
    Hawkins R
    Ann Lab Med, 2013 Mar;33(2):156-8.
    PMID: 23479565 DOI: 10.3343/alm.2013.33.2.156
    Matched MeSH terms: Reagent Kits, Diagnostic
  18. Fulltext A re-evaluation of plasma sialic acid determination using the periodate resorcinol method versus the enzymatic method
    Muniandy S, Qvist R, Zaini A, Chinna K, Ismail IS
    Southeast Asian J. Trop. Med. Public Health, 2005 Jul;36(4):1011-3.
    PMID: 16295560
    The concentration of plasma sialic acid was estimated using the modified chemical method and the more sensitive enzymatic method in 20 subjects with impaired glucose tolerance and 20 control subjects. The mean sialic acid concentration values of the control subjects and subjects with impaired glucose tolerance using the enzymatic method were 1.747 +/- 0.047 and 2.583 +/- 0.070 mmole/l and 1.753 +/- 0.067 and 2.591 +/- 1.02 mmole/l for the chemical method. The intra-assay coefficient of variation for the control subjects and for the subjects with impaired glucose tolerance were 1.963% and 1.583%, respectively, for the enzymatic assay and 2.728% and 2.431%, respectively, for the chemical assay. The inter-assay coefficient of variation for the control subjects and for the subjects with impaired glucose tolerance were 2.686% and 2.723% for the enzymatic assay, and 3.819% and 3.95% for the chemical assay. Since the values do not differ significantly, the chemical assay is a cost effective method that can be used in large epidemiological studies.
    Matched MeSH terms: Reagent Kits, Diagnostic
  19. 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
  20. Multicentre evaluation of dengue IgM dot enzyme immunoassay
    Lam SK, Fong MY, Chungue E, Doraisingham S, Igarashi A, Khin MA, et al.
    Clin Diagn Virol, 1996 Nov;7(2):93-8.
    PMID: 9137865 DOI: 10.1016/S0928-0197(96)00257-7
    The traditional methods used in the diagnosis of dengue infection do not lend themselves to field application. As such, clinical specimens have to be sent to a central laboratory for processing which invariably leads to delay. This affects patient management and disease control. The development of the dengue IgM dot enzyme immunoassay has opened up the possibility of carrying out the test in peripheral health settings.
    Matched MeSH terms: Reagent Kits, Diagnostic
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