Immunochromatographic Test Kit Research Articles

Evaluation of immunochromatographic test kits for the detection of norovirus in faecal specimens

<h3>Background</h3> The early detection of norovirus plays a vital role in the reduction of transmission and control of nosocomial viral gastroenteritis. <h3>Aim</h3> This study evaluated the immunochromatographic test kits RIDAQUICK N1402, RIDAQUICK N1403, SD BIOLINE Norovirus and ImmunoCard STAT! Norovirus. There are no current publications evaluating RIDAQUICK N1402. <h3>Method</h3> Eighty-six thawed faecal samples previously subjected to viral loading were tested with the kits and the cycle threshold value used as the standard reference. Twenty fresh faecal samples containing norovirus were also tested. <h3>Results</h3> The sensitivity for RIDAQUICK N1403, RIDAQUICK N1402, SD BIOLINE Norovirus, ImmunoCard STAT! Norovirus, using the thawed samples was 46%, 58%, 32% and 47%, respectively. Specificity for RIDAQUICK N1403 was 96% whilst the other test kits obtained 100% specificity. Using the fresh samples, sensitivity was 70% and specificity was 100% across all kits. <h3>Discussion</h3> Variances in sensitivities and specificities across test kits between the thawed and fresh samples indicate the importance of the storage of samples. Immunochromatographic test kits may be useful as a primary screening method for the detection of norovirus, however negative samples should be confirmed with more sensitive detection methods such as reverse transcriptase polymerase chain reaction (RT-PCR).

Diagnosis of scrub typhus: introduction of the immunochromatographic test in Korea

Diagnosis of scrub typhus: introduction of the immunochromatographic test in Korea

Rapid Immunochromatographic Test for the Identification and Discrimination of Mycobacterium tuberculosis Complex Isolates from Non-tuberculous Mycobacteria.

A new rapid Immunochromatographic test (ICT) kit (SDBioline TB Ag MPT64RAPID(®)) developed by Standard Diagnostics, South Korea was evaluated for rapid differentiation of M. tuberculosis from non tuberculous mycobacteria (NTM). It detects MPT 64 antigen in M. tuberculosis isolates using mouse monoclonal MPT 64 antibody. The kit was assessed for routine identification of the Acid Fast Bacilli(AFB) isolated in our laboratory. Two hundred eight culture isolates of Mycobacteria were tested using ICT test kit for detection of MPT 64 antigen from liquid and solid culture. H37Rv strain was employed as the positive reference control. Any negative result was referred for confirmation by Gen Probe Accu Probe assay for MTB Complex (Gen-Probe, San Diego, Calif.). Speciation of NTM was performed using genotypic Mycobacterium CM assay (Hain's life sciences, Germany). Of the 208 culture positive isolates tested, 182 (87.5%) were found positive for Mycobacterium tuberculosis Complex and remaining 26 (12.5%) were considered as NTM. These results were further confirmed by Gen Probe Accu probe assay that served as the reference method for detection of MTBC. H37Rv reference strain was taken as a control for ICT test and molecular tests. The reference strain showed the presence of MPT64 antigen band in the ICT test. Similar bands were formed in all MTBC (182) isolates tested, proving 100 per cent sensitivity and no bands were detected in 48 (100%) NTM isolates tested, proving 100 per cent specificity of the ICT kit. Tuberculosis is a global pandemic. Rapid identification of Mycobacteria as MTB complex or non-tuberculous Mycobacteria from culture is important for treatment of infected cases and drug susceptibility testing of the culture isolate. MPT 64 TB antgen detection using SD Bioline Immunochromatographic test is a simple and cost effective method for differentiation of Mycobacterial cultures as MTB complex from non- tuberculous Mycobacteria.

Sero-Prevalence of Hepatitis B Virus Infection among Blood Donors: A Retrospective Study in the Kintampo Municipal Hospital, Ghana

Background: Hepatitis B virus is one of the transfusion transmission infectious agents of public health relevance. Its prevalence varies across the globe. Establishing the sero-prevalence of the disease is critical to informing the direction of preventive and control strategies. Objective: The aim of this study therefore was to establish the hepatitis B surface antigen sero-prevalence among blood donors in the Kintampo municipality of Ghana. Methodology: This three-year hospital based retrospective study was conducted at the laboratory unit of the Kintampo Municipal Hospital. The laboratory uses one step immunochromatographic test kits to detect the presence of hepatitis B surface antigen in the sera of blood donors. Records on blood donors were reviewed for hepatitis B sero-positivity. Results: A total of 3402 blood donors were studied, out of which 3238 (95.2%) were males and 164 (4.8%) were females. The overall sero-prevalence of hepatitis B surface antigen was 9.6% (327/3402). Majority of the sero-positive donors were less than 40 years, with higher prevalence of 16.4% (35/214) in donors less than 20 years. The sero-prevalence in males and females was 9.7% (313/3238) and 8.5% (14/164) respectively. Conclusion: The Kintampo municipality has a relatively high prevalence of hepatitis B among blood donors. The probability of hepatitis B viral infection was age inclined as the youth seem to be at greater risk of contracting the disease.

Detection of Hepatitis C Virus (HCV) antibodies among HIV Seropositive women attending a Rehabilitation centre

Co-infection with human immunodeficiency Virus HIV and (HCV) is becoming a major global problem, leading to increased morbidity and mortality in both developed and developing countries. This research hence examines the risk factors and transmission of HIV and HCV co-infection. Two hundred and ninety (290) subjects were screened, with HCV global immunochromatographic test kit. Possible risk factors to co-infectious status of subject were determined using a well-structured questionnaire. Out of the 290 sera tested, 25 (8.6%) were positive for HCV antibodies. Considering Age of subjects screened, females aged 11-20 years recorded a high positivity of 3.1 %,( X 2 = 2.755, P-value = 0.839; P>0.05).Marital status of subjects showed that single subjects recorded 13(4.5%), (X 2 = 0.679,P-value = 0.712 ; P > 0.05)positivity compared to married subjects with 4.1%. There were no significant correlations between HCV infection with Age and Marital Status; P - values = 0.839 and 0.712 respectively (i.e P > 0.05). Significant correlation was found between HCV antibodies and educational status, (Value x 2 = 7.957,P-value = 0.047; P < 0.05).However, Volunteers with secondary school level of education recorded 10(3.4%) positivity. The result obtained showed that Seroprevalence to HCV antibodies in this study was high, hence the need for its early diagnosis among HIV patients is strongly advocated to reduce the risk of further complications among these subjects.

Simultaneous Detection of Canine Respiratory Disease Associated Viruses by a Multiplex Reverse Transcription-Polymerase Chain Reaction Assay

A multiplex reverse transcription polymerase chain reaction (mRT-PCR) assay was developed for the simultaneous detection of canine distemper virus (CDV), canine respiratory coronavirus (CRCoV) and canine influenza virus (CIV). These viral pathogens are all causative agents of canine infectious respiratory disease (CIRD). The sensitivity and specificity of the mRT-PCR were determined by comparing it to a rapid antigen test (RAT) or immuno-chromatography test kit and reverse transcription-polymerase chain reaction (RT-PCR) in the detection of CDV, CRCoV and CIV antigens present in 100 clinical samples (nasal swabs and whole blood samples) from 50 dogs with respiratory disease symptoms. This study revealed that mRT-PCR had almost exactly the same performance or results were almost 100% in agreement with that of RT-PCR and RAT both in terms of the assay sensitivity and specificity which was more highly evident in detecting CIV, CDV and CRCoV antigens present in canine nasal swab samples. Therefore, this assay could be a better alternative for the definitive and simultaneous ante-mortem detection of the three viral pathogens that cause CIRD by using nasal swabs.

HIV 急性感染期の診断における第 4 世代 HIV 迅速検査試薬の性能評価

The early diagnosis of human immunodeficiency virus (HIV) infection is important to provide effective antiviral treatment and to prevent transmission of HIV. One of the key issues to achieve this goal is to shorten the so-called "diagnostic window period" when the humoral immune response toward the virus is not fully developed during the acute phase of HIV-1 infection. In 2008, the Espline HIV Ag/Ab test kit (E4G, Fujirebio Inc. Japan) was marketed in Japan belonging to the fourth generation of HIV test kits characterized by its ability to detect both viral antigens (Ag) and anti-HIV-1/2 antibodies (Ab). E4G is the first and only fourth generation immunochromatographic HIV test kit approved in Japan at present. To evaluate its performance to diagnose acute HIV infection (AHI), E4G was compared with fourth generation Ag/Ab ELISA test kits, a third generation PA test kit, WB and real-time PCR for the testing of 25 AHI clinical specimens. E4G detected HIV infection in 18/25 specimens (sensitivity : 72.0%), of which the viral Ag was detected in only 2 specimens (8.0%) bearing a viral load > 10 million copies/mL. No spesimens were simultaneously reactive to both Ag and Ab against HIV. The third generation PA achieved a positive score of 17/ 25 specimens (68.0%), which was almost the same as the E4G figure. In contrast the fourth generation Ag/ Ab ELISA scored all the 25 AHI specimens positive (sensitivity : 100%). Overall, although having the merit of offering a rapid diagnostic test for HIV infection, E4G does not provide a sensitivity in AHI diagnosis superior to test kits currently available.

English

A study was conducted between the months of March and August, 2010 to ascertain the rate of mono- and co-infection of three blood-borne viral pathogens namely Human immunodeficiency virus (HIV), Hepatitis C virus (HCV), and Hepatitis B virus (HCV) among 500 pregnant women aged between 21 and 40, attending antenatal clinic at a tertiary health centre in Owerri. The screening of blood samples from the sample population was carried out using immunochromatographic rapid test kits including HIV1/2 test kit (Hi Tech Diagnostic Limited, Nigeria) and Bio TracerTM&nbsp;HBV and HCV Rapid card test kits (Bio Focus Limited, South Korea). Results revealed that all age groups sampled were positive for HIV, producing a total of 115 (23%) with the age group of 29 to 32 producing the highest infection rate of 32 (6.4%) while the least came from the age groups of 21 to 24 and 37 to 40, with 13 (2.6%) each. The result further revealed that only one case of HBsAg infection was recorded among the sample population within the age group of 37 to 40 with 1 (0.2%). There was no case of HCV recorded among the pregnant women neither was there a co-infection involving HIV and any of the hepatitis viruses. The monthly distribution of the viral pathogens revealed that the highest rate of HIV infection occurred in the month of March with 26 (5.2%), while the least occurred in the month of July with 13 (2.6%). The only HBV infection observed in the sample population was recorded in the month of April while none of the months under review recorded any case of HCV, HIV + HBV, or HIV + HCV coinfections among the studied pregnant women. Though no case of coinfection was recorded in this study, concurrent infection between HIV and the hepatitis viruses is a growing public health concern and enough awareness should be created to check its emergence in this part of Nigeria while the campaign against HIV monoinfection should be intensified to check its spread among the uninfected population. &nbsp; Key words:&nbsp;Coinfection, pregnant women, monoinfection, Owerri, antenatal, hepatitis, human immunodeficiency virus (HIV).

Prognostic Value of Rapid Test for Diagnosis of Dengue in Nepalese Patients during 2010 Epidemic

Dengue is an emerging vector borne disease in Nepal and rapid diagnostic test is important for early diagnosis of the disease. The aim of the study was to evaluate the diagnostic accuracy of commonly used rapid immunochromatographic test kit in Nepal during 2010 dengue epidemic and to assess disease burden of dengue. A total of 131 acute and nonacute serum samples were collected during recent epidemic of dengue in 2010 from clinically suspected Nepalese patients of different hospitals. Rapid immunochromatographic test kit was used for early diagnosis and enzyme immunosorbent was chosen as a reference assay. The sensitivity and specificity of rapid test was 70% and 76.54% respectively whereas the prevalence of the disease was 38.17%. The odds ratio for males was 1.8 however; the association with the disease was statistically not significant. The diagnostic accuracy of rapid immunochromatographic test for dengue diagnosis was low (k=0.46). So, it should be substituted by highly sensitive test device for prompt diagnosis and health personnel should consider appropriate timing of sample collection for better performance of rapid test.

Comparative analysis of different diagnostic techniques for plasmodiasis

The effectiveness in detecting malaria, of two immuno-chromatographic rapid diagnostic test (RDT) kits namely: .Global Devices One Step Rapid Test. and .SD-Bioline Malaria Pf/Pv. were evaluated by comparison with stained blood film microscopy. Blood samples of 202 patients with provisional diagnosis of malaria were tested in the laboratory for malaria parasites. The results of the stained film microscopy showed that 156 (77.2%) were positive, while the RDT kits . SD-Bioline and GlobalDevices showed positive results of 127 (62.9%) and 53(26.2%) respectively. The performance characteristics of the RDTkits, SD-Bioline and Global Devices, respectively were: sensitivity . 76.3% and 33.3%; specificity . 82.6 and 97.8%; test accuracy . 77.7% and 48.0%; positive predictive value . 93.7% and 98.1%; negative predictive value . 50.7% and 30.2%. Statistical tests of the effectiveness of the different techniques at p>0.05 and p>0.01 showed significant difference between the RDT kits andamong the three tests. Comparison of plasmodiasis infection rates between the sexes and among 4 age-groups: 0-11, 12-25, 26-49 and >50 showed no statistically significant difference at 5% and 1% alpha levels. The SD-Bioline Malaria Pf/Pv kit showed an appreciable effectiveness. It is therefore recommended for use in field screening, and in the absence of microscopist in the laboratory.

MPT 64 Antigen detection for Rapid confirmation of M.tuberculosis isolates

BackgroundA new rapid Immunochromatographic test kit(SD MPT64TB Ag Kit) for detection of MPT 64 Antigen in M. tuberculosis isolates using mouse monoclonal MPT 64 Antibody developed by SD Bioline, South Korea was evaluated for rapid identification of M. tuberculosis isolates. We also assessed the sensitivity, specificity and predictive values of this kit. The test kit has an excellent sensitivity, specificity, negative predictive value & positive predictive value. This rapid method is found to be a reliable, rapid and cheaper method for confirming MTB culture isolates in resource poor laboratories. Material/methods: 54 culture isolates of M. tuberculosis in broth & on LJ medium, 12 Non mycobacterial isolates, 10 Non tubercular (NTM) rapidly growing Mycobacteria isolated from pus & 5 smear positive sputum samples were tested for detection of MPT64 antigen using the SD Bioline immunochromatography (ICT)test kit. H37 RV strain was employed as the positive reference control.FindingsH37 RV strain showed the presence of MPT64 antigen band. Similar band was formed in all the 54 MTB isolates tested proving 100% sensitivity. MPT64 band formation was not detected in any of the other test isolates which proved the 100% specificity of the test kit. Both PPV & NPV were 100%.ConclusionTuberculosis is a global pandemic. Rapid identification of MTB culture isolate is very important for drug susceptibility testing. MPT 64 TB Ag detection ICT kit is a rapid, reliable method; it can be a substitute for the molecular identification methods.

Development of a novel rapid immunochromatographic test specific for the H5 influenza virus

Three anti-H5 influenza virus monoclonal antibody (mAb) clones, IFH5-26, IFH5-115 and IFH5-136, were obtained by immunising a BALB/C mouse with inactivated A/duck/Hokkaido/Vac-1/04 (H5N1). These mAbs were found to recognise specifically the haemagglutinin (HA) epitope of the influenza H5 subtypes by western blotting with recombinant HAs; however, these mAbs have no neutralising activity for A/duck/Hokkaido/84/02 (H5N3) or A/Puerto Ric/8/34 (H1N1). Each epitope of these mAbs was a conformational epitope that was formed from the regions located between 46 to 60 amino acids (aa) and 312 to 322 aa for IFH5-115, from 101 to 113 aa and 268 to 273 aa for IFH5-136 and from 61 to 80 aa and 290 to 300 aa for IFH5-26. The epitopes were located in the loop regions between the receptor region and alpha-helix structure in haemagglutinin 1 (HA1). Influenza A virus H5-specific rapid immunochromatographic test kits were tested as solid phase antibody/alkaline phosphate-conjugated mAb in the following three combinations: IFH5-26/IFH5-115, IFH5-136/IFH5-26 and IFH5-136/IFH5-115. In every combination, only influenza A H5 subtypes were detected. For effective clinical application, rapid dual discrimination immunochromatographic test kits in combination with H5 HA-specific mAb, IFA5-26 and IFA5-115 and the influenza A NP NP-specific mAb, FVA2-11, were developed. The dual discrimination immunochromatographic tests kits detected influenza A virus H5 subtypes as H5 line-positive and all influenza A subtypes as A line-positive simultaneously. The dual discrimination immunochromatographic test kits may be useful for discriminating highly pathogenic avian influenza A H5N1 viruses from seasonal influenza A virus, as well as for confirming influenza infection status in human, avian and mammalian hosts.

Development of Two Types of Rapid Diagnostic Test Kits To Detect the Hemagglutinin or Nucleoprotein of the Swine-Origin Pandemic Influenza A Virus H1N1

Since its emergence in April 2009, pandemic influenza A virus H1N1 (H1N1 pdm), a new type of influenza A virus with a triple-reassortant genome, has spread throughout the world. Initial attempts to diagnose the infection in patients using immunochromatography (IC) relied on test kits developed for seasonal influenza A and B viruses, many of which proved significantly less sensitive to H1N1 pdm. Here, we prepared monoclonal antibodies that react with H1N1 pdm but not seasonal influenza A (H1N1 and H3N2) or B viruses. Using two of these antibodies, one recognizing viral hemagglutinin (HA) and the other recognizing nucleoprotein (NP), we developed kits for the specific detection of H1N1 pdm and tested them using clinical specimens of nasal wash fluid or nasopharyngeal fluid from patients with influenza-like illnesses. The specificities of both IC test kits were very high (93% for the HA kit, 100% for the NP kit). The test sensitivities for detection of H1N1 pdm were 85.5% with the anti-NP antibody, 49.4% with the anti-HA antibody, and 79.5% with a commercially available influenza A virus detection assay. Use of the anti-NP antibody could allow the rapid and accurate diagnosis of H1N1 pdm infections.

Prevalence of Treponema pallidum Infection among Human Immunodeficiency Virus Seropositive Persons and Their Corresponding CD4 Counts in a Nigerian Cohort

Background: Sexually transmitted infections are a major public health problem especially with the advent of HIV/AIDS. This study was conducted to determine the prevalence of Syphilis among HIV seropositive persons. The study population was seropositive persons accessing antiretroviral therapy (ART) at the Federal Medical Center Keffi. Methodology: Venous blood (5ml) was collected from each of the 200 consenting participants between February and August 2010. Their syphilis serostatus was determined using Rapid Plasma Reagin test and confirmed by an immunochromatographic rapid syphilis test kit. The CD4 count of the positive sample was also determined. Results: Of the 200 persons screened, 56 were males and 144 were females. The prevalence of Treponema pallidum in this study population was 0.5% (1/200). The HIVsyphilis positive was a married man aged 35 years and with a CD4 cell count of ≥ 200 cells/uL. Conclusion: This study reported a very low prevalence of syphilis among HIV positive persons. It is recommended that the sexual partner(s) of the study index case should be traced and also treated to prevent reinfection and/or continued spread of the infection. Despite the low prevalence in this study, syphilis screening among those with HIV should be advocated routinely to avoid the complications associated with the dual infection.

Immunochromatography test kit for detection of dexamethasone and prednisolone in herbal medicinal products

Immunochromatography test kit for detection of dexamethasone and prednisolone in herbal medicinal products

Identification of adulterated sheep and goat cheeses marketed in Romania by immunocromatographic assay

The authenticity of different animal food products has important attention in many countries received in the last few years. The majority of dairy products' authenticity identification methodologies are based on major milk proteins analysis. One of the main problems in cheese making is the adulteration of sheep and goats milk with cow's milk, because cow's milk is cheaper. The aim of this paper is to detect the presence of cow's milk in sheep's and goat's cheeses which are sold in the retail markets of Romania. For this purpose, a total of 73 sheep's and goat's cheese samples were purchased randomly from different markets. An immunochromatographic test kit was used to detect the presence of cow's milk in sheep and goat cheeses. No adulteration was found in 32.6% and 20.3% of sheep and goat cheese samples, respectively, while the presence of cow's milk was detected in 67.3% and 79.7% of samples, respectively. These results were considered to be unacceptable and routine controls on adulterated sheep and goat cheese should be performed in Romania.

Evaluation of the Newly Developed Immunochromatography Test Kit for Rapid Detection and Differentiation of Norovirus GI and GII

Evaluation of the Newly Developed Immunochromatography Test Kit for Rapid Detection and Differentiation of Norovirus GI and GII

A novel method for rapid detection of Streptococcus pneumoniae antigen in sputum and its application in adult respiratory tract infections

A highly sensitive immunochromatography test kit, ODK0501, was developed using specific polyclonal antibodies against the C-polysaccharide moiety of Streptococcus pneumoniae for the rapid detection of S. pneumoniae antigen in sputum samples. The clinical utility of ODK0501 for this detection was evaluated prospectively in 52 adult patients with respiratory infections and compared with that of a urinary antigen detection kit. Overall, 21 patients (40.4 %) showed positive results with ODK0501, compared with 16 patients (30.8 %) using the urinary antigen detection kit, and S. pneumoniae was cultured from 18 patients. ODK0501 and the urinary antigen detection kit exhibited a sensitivity of 94.4 and 55.6 % (P<0.01), respectively, and a specificity of 88.2 and 82.4 %, respectively. Eleven of thirteen patients with conflicting results between the two test kits exhibited consistent results for sputum cultures. Moreover, eight out of nine patients positive for ODK0501 and negative for the urinary antigen detection kit were S. pneumoniae culture-positive, including five who exhibited phagocytosis, indicating S. pneumoniae as a causative agent of infection, in Gram staining of sputum samples. These results suggest that the ODK0501 direct sputum detection kit is more clinically useful than the urinary antigen detection kit in adult patients with respiratory infections.

A simple and rapid immunochromatographic test kit for rabies diagnosis

ABSTRACTIn rabies endemic countries, funds and infrastructure are often insufficient to employ the approved gold standard for the definitive diagnosis of rabies: the direct fluorescent test. In the present study, two types (type 1 and 2) of an ICT kit were evaluated for detection of rabies. These were developed using monoclonal antibodies which recognize epitope II and III of the nucleoprotein of rabies virus. Both kits specifically detected all rabies virus strains and there was no cross reactivity with Lyssaviruses (Lagos, Mokola and Duvenhage), Rhabdovirus (VSV and Oita 296/1972) and other common canine‐pathogenic viruses. In type 1, a single type of monoclonal antibody was used. It was capable of detecting recombinant nucleoprotein and showed sensitivity of 95.5% (42/44) and specificity of 88.9% (32/36) using brain samples from rabid dogs. In contrast, type 2 which was made of two different monoclonal antibodies had a lower sensitivity of 93.2% (41/44) and higher specificity of 100% (36/36). These ICT kits provide a simple and rapid method for rabies detection. They need neither cold chain for transportation nor complicated training for personnel. This diagnostic test is suitable for rabies screening, particularly in areas with a high prevalence of rabies and where the fluorescent antibody test is not available.

Evaluation of the Detection Threshold of Three Immonochromotographic Rapid Diagnostic Test (RDT) Kits for Falciparum Malaria Using Titration Technique

The detection threshold of three immunochromatographic Rapid Diagnostic Test (RDT) Kits namely: HEXAGON MALARIA, ACCU-STAT MALARIA and SD-BIOLINE were studied using titration techniques. Parasitaemia values of pooled Plasmodium falciparum-positive specimens from 200 patients were determined. The samples were then prepared in 13 different dilutions and used to titrate the three RDT's in parallel in order to establish their detection threshold using the corresponding parasite density. Results showed that the average parasite density of these samples was 12,800 parasites per microlitre. HEXAGON MALARIA had a detection threshold of 50 matured parasites and 280 small trophozoites per microlitre, while SD-BIOLINE (Pv/Pf) and ACCU-STAT MALARIA recorded detection thresholds of 280 and 400 parasites per microlitre respectively, irrespective of the age and size of the parasites. Five of these patients gave positive results with all the three kits but were negative by microscopy. A mean count of 39 pigments per microlitre was obtained for these five patients. Both HEXAGON MALARIA and SD-BIOLINE had a detection threshold of 4 pigments per microlitre, while ACCU-STAT MALARIA had 20 pigments per microlitre. This suggests that these three kits have good detection thresholds and could therefore be suitable for mass screening for malaria parasites especially in malaria endemic areas where electricity, equipment and highly-skilled microscopists may be inadequate. Keywords: Rapid Diagnostic kits, falciparum Malaria, Detection Threshold Journal of Medical Laboratory Science Vol. 13 (2) 2004: pp. 45-50