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Immunochromatographic Assay

Immunochromatographic Assay: A rapid, sensitive, and specific diagnostic technique that combines the principles of immunoassay and chromatography.
This method allows for the qualitative or semi-quantitative detection of target analytes, such as proteins, antibodies, or other biomolecules, in a sample.
The assay typically involves the use of a test strip that contains a membrane coated with capture reagents, which interact with the target analyte and produce a visible signal, often in the form of a colored line or band.
Immunochromatographic assays are widely used in point-of-care testing, clinical diagnostics, and environmental monitoring due to their ease of use, fast turnaround time, and portability.
This technique is particularly useful for the detection of infectious diseases, drug abuse, pregnancy, and other health conditions.

Most cited protocols related to «Immunochromatographic Assay»

As part of the World Health Organization (WHO) pre-qualification of in vitro diagnostics assessment, four dual HIV/Syphilis RDTs were evaluated between 2014 and 2016 by WHO at the Institute of Tropical Medicine (Antwerp, Belgium). SD Bioline HIV/Syphilis Duo (Standard Diagnostics, Republic of Korea, product number 06FK30; version instructions for use (IFU) 2013/05), DPP HIV-Syphilis Assay (Chembio Diagnostic Systems, United States, product number 659525; version IFU 10–6307-0Rev1) and Multiplo Rapid TP/HIV Antibody Test (Medmira, Canada, product number 815311005145; version IFU MPSIPYZIS0002EN Rev3/1) were evaluated simultaneously. The evaluation of Insti Multiplex HIV-1/HIV-2/Syphilis Antibody Test (bioLytical Laboratories, Canada, product number 90–1032; version IFU 50-1143E) was performed at a later time point. The SD Bioline and the DPP assay are lateral flow (immunochromatographic) RDTs while Multiplo and INSTI are RDTs based on the flow through (immunofiltration) principle. All assays were performed by one operator (blinded to the reference results) according to the manufacturer’s instructions for use (IFU). The test characteristics of the assays are described in Table 1.

Test characteristics

SD Bioline HIV/Syphilis DuoDPP HIV-Syphilis AssayMultiplo Rapid TP/HIV Antibody TestInsti Multiplex HIV-1/HIV-2/Syphilis Antibody Test
Type of assayLateral flow immunochromatographic assayLateral flow immunochromatographic assay (dual path platform)Vertical flow immunofiltration immunoassay (flow through)Vertical flow immunofiltration immunoassay (flow through)
SpecimenSerum, plasma, whole bloodSerum, plasma, whole bloodSerum, plasma, whole bloodSerum, plasma, whole blood
Volume required10 μl of serum/plasma10 μl of serum/plasma1 drop of whole blood/serum/plasma (35-40 μl)50 μl of whole blood/serum/plasma
20 μl of whole blood1 sample loop or 10 μl of whole blood
Time to results15–20 min15–25 minOnce all fluid is absorbedImmediately after adding the Clarifying Solution
(+/− 3 min)
(+/− 1–2 min)
EquipmentTimerTimerNoneNone
HIV componentHIV-1/2 recombinant antigens (gp41, gp36 and HIV-1 group O)HIV-1/2 recombinant antigens (not specified)HIV-1/2 synthetic peptides (gp36, gp41, gp120 and HIV-1 group O)HIV-1/2 recombinant antigens (gp41, gp36)
TP componentRecombinant antigen (17 kDa)IgG/IgM recombinant antigen (not specified)IgG/IgM recombinant antigens (15 kDa, 17 kDa, 47 kDa)Recombinant fusion proteins derived from p17 and p47 domains
Steps to performAdd the specimen.Add the specimen to the Sample Tainer (with buffer), mix.Add 3 drops of buffer to the device.Add the specimen to the Sample diluent vial, mix.
Add 3 drops of diluent.Add the specimen.
Add 2 drops to the test device at Well 1.Place the InstantGoldCap.Add the content of this vial to the device.
Add 4 drops of buffer to the test device at Well 2.Add 12 drops of buffer.Add the Colour Developer.
Remove the InstantGoldCap.Add the Clarifying Solution.
Add 3 drops of buffer.
Result interpretationClearClearClearThere is no marker on the devices to indicate the position of the HIV, syphilis and control dot.
Publication 2019
Antibodies Antigens Biological Assay Buffers Diagnosis HIV-1 HIV-2 HIV Antibodies HIV Envelope Protein gp120 Immunoassay Immunochromatographic Assay Immunochromatography Medical Devices O Antigens Peptides Plasma Recombinant Fusion Proteins Rhabdoid Tumor Serum Syphilis Syphilis Serodiagnosis
All patients younger than 2 years who referred to Paediatric Emergency Unit of S.Orsola-Malpighi Hospital of Bologna (Italy) for suspected acute RSV infection during 3 consecutive winter seasons from September to April (2007–2008, 2008–2009, 2009–2010) were included.
RSV infection was suspected in presence of fever, cough, respiratory distress with tachypnea, cyanosis, feeding difficulties; RSV rapid test was performed on nasopharyngeal secretions to all infants admitted to the unit presenting these symptoms.
Every week we recorded the number of infants who were tested with BINAX NOW, a rapid immunochromatographic assay for the qualitative detection of RSV fusion protein antigen in nasopharyngeal secretions.
Meteorological data of the geographic area of Bologna (minimum temperature,°C; relative humidity, %) were recorded from Bologna Borgo Panigale meteorological station; data were summarized as mean values for each week.
Air pollution data (PM10 and PM2,5 mean weekly concentration) of the same area were recorded from Bologna San Felice monitoring station by Bologna Department of the Regional Environmental Protection Agency (ARPA).
Ethics approval was not required for this observational and anonymous study. Consent was obtained for all patients.
Statistical analysis was performed with Microsoft Excel 2010. Pearson’s correlation was used to correlate the weekly number of RSV positive cases with meteorological parameters (mean minimum temperature, mean relative humidity) and air pollutants (PM10 and PM2,5) mean concentrations. A value of r>0,3 was considered statistically significant.
The number of RSV infections was also correlated to the climatic parameters of the same week (no lag), or one (1-week lag), two (2-week lags) or three (3-week lag) weeks before, aiming to identify a delay in the effect of temperature or humidity on RSV epidemics.
Considering air pollutants, we correlate the weekly number of RSV infections with the mean weekly concentration (μg/m3) of PM10 and PM2,5 measured in the same week (no lag) and in the previous week (1-week lag) aiming to enlight the short-term effect of air pollutants exposure.
Publication 2013
Air Pollutants Air Pollution Antigens Climate Cough Cyanosis Enlight Epidemics Fever Humidity Immunochromatographic Assay Infant Nasopharynx Patients Respiratory Rate Respiratory Syncytial Virus Infections Secretions, Bodily Staphylococcal Protein A Youth
After a COVID-19 outbreak in the Falles festival with several mass gathering events (MGEs) in Borriana (Spain) during March 2020 [25 (link)], we followed a population-based prospective cohort of patients until October 2020 [26 (link)] to estimate disease evolution and incidence of complications post-COVID-19, and its relationship with participants ABO blood group. The study was carried by the Public Health Center of Castelló, and the Emergency and Microbiology and Clinical Analysis Services of Hospital de la Plana Vila-real (Spain).
We performed the first study of the COVID-19 outbreak during May–June 2020 through a serological survey and questionnaire interview [25 (link)]; we included 1338 people in the study, and we found 570 COVID-19 patients with 536 patients, laboratory-confirmed tests: electrochemiluminescence immunoassay (ECLIA) (Elecsys®, Mannheim, Germany, Anti-SARS-CoV-2, Roche Diagnostics) [27 (link)], in 514 patients, lateral flow immunochromatographic assay (LFIC), in 15 patients, and reverse transcriptase–polymerase chain reaction (RT-PCR) in 39 patients [25 (link)]. ABO was determined by the gel test (ID-Card ABO/RhD, DiaMed GmbH, Bio-Rad Laboratories Switzerland) [28 (link)].
In October 2020, health staff of the Hospital de la Plana Vila-real, and health centers of Borriana, Vila-real, Onda, and La Vall d’Uixo conducted a telephone interview of each participant to obtain information about their health situation, medical assistance, illness’s evolution, symptoms post-COVID-19, and duration. In addition, we acquired data from the May–June questionnaire on age, sex, weight, height, body mass index (BMI) (kg/m2), occupation, level of physical exercise, smoking habits, consumption of alcohol, chronic illness, and COVID-19 exposures. COVID-19 exposition included the following features: see a person with a cough at MGEs, attendance MGEs ≥ 2, contact with a COVID-19 case, and family with COVID-19 case.
Publication 2021
Biological Evolution Cough COVID 19 Diagnosis Disease, Chronic Emergencies Immunoassay Immunochromatographic Assay Index, Body Mass Patients Personnel, Hospital Planum Reverse Transcriptase Polymerase Chain Reaction SARS-CoV-2
The AFIAS HBsAg, anti-HBs, and anti-HCV tests can detect targets using an Eu(III) fluorescence immunochromatography-based lateral flow assay. All measurements were performed using a semi-automated AFIAS involving a disposable test strip. First, 100 µL of each sample was added to the sample pad containing a dried fluorescence-labeled detector antigen or antibody, and the sample was then moved onto the test strip by capillary action. If the target antigen or antibodies were present in the sample, they would react with the fluorescence-conjugated antibody or antigen to form an antibody-antigen complex on the nitrocellulose membrane. Fluorescence intensities of the target markers and control materials were detected using a portable fluorescence reader (AFIAS-6 reader). Fluorescence in the control line of the cartridge indicates adequate sample and capillary movement. AFIAS contains lot-specific information and stored calibration statistics based on the values of serially diluted standard materials. The system can test three strips simultaneously within 20 minutes using 100 µL of each sample. Quality control samples were tested daily to verify test results. The sample results are presented as “positive” (HBsAg ≥1.0, anti-HBs ≥15.0, and anti-HCV ≥1.0), “negative” (HBsAg <0.9, anti-HBs <5.0, and anti-HCV <0.9), or “indeterminate” (0.9 ≤HBsAg <1.0, 5.0 ≤anti-HBs <15, and 0.9 ≤anti-HCV <1.0) in the form of a relative cut-off index (COI).
Publication 2018
Antibodies Antigens Capillaries Capillary Action Complex, Immune Fluorescence Fluorescent Antibody Technique Hepatitis B Surface Antigens Hepatitis C Antibodies Immunochromatographic Assay Immunoglobulins Movement Nitrocellulose Tissue, Membrane
All incidence IAs were applied independently in CEPHIA laboratories (at Blood Systems Research Institute, San Francisco and Public Health England, London) using standard operating procedures. The laboratory technicians were trained by the developers and blinded to the specimen background information, and controls were tested regularly to ensure stability of the assays and procedures. Testing protocols are available on the CEPHIA website [14 ].
Five assays have been previously summarized [12 (link)]: LAg aims to describe the avidity of HIV antibodies through a Normalized Optical Density (ODn) [18 (link), 19 ]; BED captures the relative amount of immunoglobulin G that is specific to HIV, also as a Normalized Optical Density (ODn) [20 (link), 21 ]; LS-Vitros quantifies the level of HIV antibodies as a Signal-to-Cutoff (S/C) value [22 (link)]; and Vitros Avidity [22 (link)] and BioRad Avidity [23 ] each measure antibody avidity as an Avidity Index (AI), reported as a percentage.
The Architect Avidity and Geenius assays, which have not been previously described, are summarized below.
Architect Avidity is based on a modification of the ARCHITECT HIV Ag/Ab Combo assay (Abbott Diagnostics; Wiesbaden; Germany) [24 (link), 25 ], which is a chemiluminescent microparticle immunoassay for the detection of p24 antigens and HIV-1/2 antibodies. Each specimen is tested in the presence and absence of a chaotropic agent (guanidine), and the ratio of the reactivity (treated to untreated) produces an Avidity Index (AI), with measurements below 80% conventionally interpreted as representing ‘recent’ infection.
The Geenius HIV 1/2 Supplemental Assay (Bio-Rad Laboratories, Inc.; Hercules; CA) is a immunochromatographic assay in the form of a rapid test [26 (link), 27 ]. The amount of HIV antibody that is specific to each of a number of antigens – namely gp36 and gp140 for HIV-2; and p31, gp160, p24 and gp41 for HIV-1 – is reported as a band intensity. For ‘recent’ infection testing, the developer proposes the use of a single summary quantitative measure, equal to the sum of the intensities for p31, gp160 and gp41, divided by the intensity for the control line. Referred to as the Geenius Index (GI), GI values below 1.5 are then interpreted as indicating ‘recent’ infection.
Publication 2016
Antibody Avidity Antigens Biological Assay Cell-Derived Microparticles Diagnosis GP 140 Guanidine Hemic System HIV-1 HIV-2 HIV Antibodies HIV Envelope Protein gp160 Immunoassay Immunochromatographic Assay Immunoglobulin G Infection Laboratory Technicians Vision

Most recents protocols related to «Immunochromatographic Assay»

First, 80 mL deionized water was added to 10 g of NIB grains in a beaker and treated directly by BSD ACP for 20 or 30 min to generate PAW bubbles. Ice cubes were placed around the treatment beaker to avoid temperature increase during the direct BSD ACP treatment (treatments A, B). In the indirect treatment (treatment C), 80 mL deionized water was treated with BSD ACP for 30 min and the generated PAW bubbles were used for steeping the NIB grains. To evaluate DON degradation during the malting process, the grains were steeped in PAW bubbles for 5 h, drained for 5 min, and air rested (19 h) at 15 ± 0.3 °C, 78 ± 3% RH after the treatments. The grains were dried at room temperature for 2 days and DON content was determined using Reveal® Q+ test kits (Neogen, Lansing, MI, USA) based on the single-step lateral flow immunochromatographic assay. The limit of detection and the specificity of the kits for DON were 0.3 ppm, and 100%, respectively. The kits were validated previously by HPLC, and their accuracy confirmed to be >90%. For measuring DON content after direct CJ ACP treatment, 180 mL water was added to 10 g NIB grains inside the treatment chamber (Figure 4B), and the grains were treated for 30 min and 1 h to produce PAW bubbles followed by steeping (5 h overall), draining (5 min), and air rest (19 h) at 15 ± 0.3 °C, 77 ± 4% RH. The grains were then dried, and DON content was determined using Reveal® Q+ test kits as above.
Publication 2023
Cereals Cuboid Bone Fever High-Performance Liquid Chromatographies Immunochromatographic Assay
The 500 g maize samples used were those specifically obtained for mycotoxin analysis. Aflatoxin and fumonisin analyses were conducted using AgraStrip® Total Aflatoxin and Fumonisin quantitative test kits provided by Romer Labs®, Inc., Union, MO, USA. The AgraStrip® Total Aflatoxin Quantitative Test is a one-step lateral flow immunochromatographic assay that determines a quantitative level for the presence of total aflatoxin. The AgraStrip® Total Fumonisin Quantitative Test is a one-step lateral flow immunochromatographic assay that determines a quantitative level for the presence of total fumonisin. In both tests, sample grinding, extraction, solute preparation and test procedures were undertaken in accordance with the manufacturer’s instructions (Romer Labs Methods, romerlabs.com (Accessed on 10 February 2020).
Publication 2023
Aflatoxins Fumonisins Immunochromatographic Assay Maize Mycotoxins
Panbio COVID-19 Ag rapid test device by Abbott (Lake Country, IL, U.S.A) is a membrane-based immunochromatography assay which detects the nucleocapsid protein of SARS-CoV-2 in nasopharyngeal samples. Collected swabs were transferred into dedicated sample collection tubes containing a lysis buffer provided with the test kit. Samples were processed on site, directly after collection. After 15 minutes of assay initiation, tests were interpreted. The test results were documented on the questionnaire as well as the image of the result window on the test device for processing and analysing the data by the researcher. The laboratory analysts involved in doing RT-qPCR were not informed about the result of the Ag-RDTs.
Publication 2023
Biological Assay Buffers COVID 19 Immunochromatographic Assay Medical Devices Nasopharynx nucleocapsid phosphoprotein, SARS-CoV-2 Rhabdoid Tumor Specimen Collection Tissue, Membrane
We consecutively enrolled all hospitalized patients who were diagnosed with a UTI caused by a CRE strain. Both community-acquired and hospital-acquired (with symptoms onset >48 h after admission) infections were accounted for.
Inclusion criteria: (i) all adult patients (≥18 years), (ii) with a clinical syndrome suggestive of UTI (such as dysuria, fever, urinary incontinence, frequency, suprapubic pain, hematuria, or pain in the lumbar region), (iii) pyuria [≥10 white blood cell count (WBC)/mm3], and (iv) the isolation of an Enterobacterales strain in urine culture [≥105 colony forming units (CFU)/mL)] that presented resistance to at least one carbapenem. We included only one isolate per patient and excluded those with CRE colonization.
For antibiotic susceptibility testing, the disk diffusion method and the Microscan automated antibiogram were used. Isolates resistant to at least one carbapenem (according to the EUCAST criteria) were tested for carbapenemase production using the immunochromatographic test NG-Test® CARBA5 (NG Biotech, Guipry, France), a rapid test able to simultaneously detect 5 types of carbapenemases: KPC, OXA, VIM, Imipenemases (IMP), or NDM. Numerous studies analyzed the sensitivity and specificity rates of this rapid test with very promising results; for example, Kanahashy et al. reported a sensitivity of 92.3%, a specificity of 100%, and a negative predictive value of 93.1% [61 (link)], with Liu et al. finding similar rates, with a 100% specificity and a 92.1% sensitivity rate [62 (link)]. Additionally, Huang et al. reported a noteworthy sensitivity of 100% and a specificity of 99% [63 (link)]. Moreover, for the first 60 isolated strains, we also performed a genotypic test using the Xpert® CARBA-R test (Cepheid, Sunnyvale, CA, USA), a PCR test compatible with the GeneXpertR Dx System device, for the detection and differentiation of the blaKPC, blaNDM, blaVIM, blaOXA-48, blaOXA-181, and blaIMP-1 genes, which were associated with resistance to carbapenems.
In addition, for colistin-resistant strains, we used the NG-Test® MCR-1 immunochromatographic assay (NG Biotech, Guipry, France) to identify the mcr-1 gene. The research group led by Volland et al. developed and validated in 2019 the NG Test® MCR-1 assay for the rapid detection of the mcr-1 gene by using monoclonal antibodies obtained via the immunization of Biozzi mice in laboratories. Thus, they achieved 100% sensitivity and 98% specificity, and the test demonstrated the ability to detect even mcr-2 genes at a cost of only a slightly lower specificity [64 (link)].
Publication 2023
Adult Antibiogram Antibiotics Biological Assay carbapenemase Carbapenems Colistin Diffusion Dysuria Fever Genes Genotype Hematuria Hypersensitivity Immunochromatographic Assay Immunochromatography Infection Leukocyte Count Low Back Pain Medical Devices Mice, Biozzi Monoclonal Antibodies Pain Patients Strains Susceptibility, Disease Syndrome Urinary Incontinence Urine Vaccination
All subjects who consented for HIV had a rapid HIV test performed at the Kality laboratory. HIV rapid testing followed the standard prison algorithm of sequential testing following the national guidelines [8 ]. I Initial testing used KHB (Shanghai Kehua Bioengineering, Ltd, Shanghai, China) kit [9 ], subsequent confirmation with HIV1/2 STAT-PAK (CHEMBIO Diagnostic systems, Inc., Medford, NY, USA) [10 ] and resolution of discordance with Uni-Gold (Trinity Biotech, Jamestown, NY, USA). All tests used an immunochromatographic assay method with various levels of sensitivity and specificity [11 ] (Table 1).
Publication 2023
Diagnosis Gold HIV-1 Immunochromatographic Assay

Top products related to «Immunochromatographic Assay»

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The Panbio COVID-19 Ag Rapid Test Device is a qualitative lateral flow assay for the detection of SARS-CoV-2 antigens in nasal swab specimens. The device provides results within 15-20 minutes.
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Determine HIV-1/2 is a laboratory diagnostic test used to detect the presence of antibodies to the human immunodeficiency virus (HIV) types 1 and 2 in human serum or plasma samples. The test utilizes immunoassay technology to provide a qualitative result, indicating whether the sample is reactive or non-reactive for HIV-1 and/or HIV-2 antibodies.
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ChromID ESBL agar is a selective and chromogenic culture medium used for the detection and identification of extended-spectrum beta-lactamase (ESBL)-producing Enterobacteriaceae from clinical samples. The medium allows the direct enumeration and presumptive identification of ESBL-producing bacteria based on their distinct colony color.
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More about "Immunochromatographic Assay"

Immunochromatographic Assay, also known as lateral flow assay or rapid test, is a powerful diagnostic technique that combines the principles of immunoassay and chromatography.
This method allows for the quick, sensitive, and specific detection of target analytes such as proteins, antibodies, or other biomolecules in a sample.
The assay typically involves the use of a test strip that contains a membrane coated with capture reagents.
When the sample is applied, the target analyte interacts with these capture reagents, producing a visible signal, often in the form of a colored line or band.
This rapid and easy-to-use format makes immunochromatographic assays widely used in point-of-care testing, clinical diagnostics, and environmental monitoring.
Some common examples of immunochromatographic assays include the Vitek 2 system for microbial identification, the Panbio COVID-19 Ag Rapid Test Device for detecting SARS-CoV-2 antigen, the BinaxNOW rapid test for COVID-19, the Determine HIV-1/2 test for HIV detection, the ChromID ESBL agar for identifying extended-spectrum beta-lactamase-producing bacteria, the Asan Easy Test® COVID-19 IgG/IgM for antibody detection, and the Xpert Carba-R assay for identifying carbapenemase-producing organisms.
These rapid tests offer many advantages, such as fast turnaround time, portability, and ease of use, making them invaluable tools in various fields, including infectious disease diagnosis, drug abuse screening, pregnancy testing, and more.
With the continual advancements in this technology, immunochromatographic assays are poised to play an even more significant role in the future of healthcare and environmental monitoring.