Rapid Test Kit

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Introduction
Chikungunya virus (CHIKV) is an insect-borne virus, of the genus Alphavirus, that is transmitted to humans by virus-carrying Aedes mosquitoes. There have been recent breakouts of CHIKV associated with severe illness. CHIKV causes an illness with symptoms similar to dengue fever. CHIKV manifests itself with an acute febrile phase of the illness lasting only two to five days, followed by a prolonged arthralgic disease that affects the joints of the extremities. The pain associated with CHIKV infection of the joints persists for weeks or months, or in some cases years. As clinical symptoms & signs of this infection resemble those of many other infectious diseases including Dengue fever, clinical findings need to be confirmed by laboratory diagnostic techniques.

Principle (antigen-antibody reaction)
Advantage chikungunya igm card is one step immunochromatographic assay. The test sample is introduced to and flows laterally through an absorbent pad where it mixes with the conjugate. If the sample contains Chikungunya specific IgM antibodies, it forms a complex with the chikungunya antigen gold colloid conjugate. The complex then migrates through the nitrocellulose membrane by caplillary action. When the complex meets the line of immobilized Antihuman IgM antibodies (Test line, ‘T’), it generates a pink purple line, indicating that the sample is reactive. To serve as a procedural control, an additional control line ‘C’ has been immobilized at a distance from the test line on the strip. If the test is performed correctly, this will result in the formation of a pinkish-purple line at the control region upon contact with the conjugate.

Material provided1. Advantage Chikungunya Card
2. Sample Dropper
3. Instruction Manual

Description of symbols usedThe following are graphical symbols used in or found on J. Mitra diagnostic products and packing. These symbols are the most common ones appearing on medical devices and their packing. They are explained in more detail in the European Standard EN ISO 15223-1:2016

Product Details:

4th Generation Microlisa HIV Ag & Ab Elisa Test for the Detection of HIV-1 p24 Antigen and antibodies to HIV-1 (including Group O & Subtype C) and HIV-2 in Human Serum / Plasma)

Additional Information:

• Packaging Details: 96 Test

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Rapid Visual Test for the Differential and Simultaneous Detection of S.Typhi IgM & IgG antibodies in Human Serum / Plasma

Additional Information:

• Packaging Details: 50 Test

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Oscar Troponin-I Card test is intended used for qualitative detection of cardiac Troponin-I (cTnI) in human serum / plasma as in aid of myocardial infarction (MI) / heart attack. This test can be used in emergencies /ICUs for diagnosis of MI in the suspected cases of cardiac attack. It is for in-vitro diagnostic use only. The test is based upon immuno-chromatographic principle. Monoclonal antibodies of Troponin-I have been used in the test formulation to make it highly sensitive and specific. Serum / plasma are preferred choice for testing. NO buffer is required along with serum / plasma for performing the test. Oscar Troponin-I Card test has shelf life of 24 months from date of manufacturing if stored at 2-30°C under sealed condition. Each kit of Oscar Troponin-I Card test contains 10 pieces of individually sealed pouches containing test cards and disposable sample droppers. Test can be performed using 2-3 drops of serum / plasma and result can be read within 5-20 minutes.

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C-Reactive Protein (CRP) latex slide test Serology kit is used for the qualitative and semi-quantitative measurement of C-reactive protein (CRP) in human serum.

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The 3x10ml Anti-ABD Blood Grouping Kit is a diagnostic tool used for the determination of blood groups in individuals based on the ABO blood group system. This kit is essential for identifying a person’s blood type (A, B, AB, or O) and ensuring compatibility during blood transfusions, organ transplants, and other medical procedures where matching blood types is critical. It uses monoclonal antibodies to react specifically with the A, B, and AB antigens found on the surface of red blood cells.

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Hiv Antibody Test Kit                                   

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Summary
Syphilis is a sexually transmitted (venereal} disease caused by the spirochete Treponema pallidum. After infection the hostforms Treponemal antibodies fo Treponema pallidum, in addition, the host also forms Non Treponemal antilipoidal antibodiesin response to the lipoidal material released from the damaged host cell. These antibodies are traditionally referred to as‘Reagins.'
The Rapid Plasma Reagin (RPR) / Carbon Antigen testis a macroscopic nonTreponemal flocculation test for the detection andquantitation of antilipoidal antibodies. Non-Treponemal tests like Carbogen? are of great value when used for screeningand follow up of therapy.


Reagents
1. Carbogen’ reagent: Aparticulate carbon suspension coated with lipid complexes.
2. Positive control, reactive with the Carbogen reagent.
3. Negative control, non reactive with the Carbogen reagent.
Carbogen detects antilipoidal antibodies in serum or plasma. As against the conventional V.D.R.L. reagents, test samplesdonot require heat inactivation.
Each batch of reagent undergoes rigorous quality control at various stages of manufacture for its specificity, sensitivity andperformance.


Principle
During the testing procedure, the specimen, serum or plasmais mixed with the Carbogen’ reagent and allowed to react foreight minutes. If antilipoidal antibodies are present in the specimen, they will react with the Carbogen reagent formingvisible black floccules. |fantilipoidal antibodies are not presentin the specimens, there will be no flocculation.

Product Details:

Syphilis is a sexually transmitted (venereal) disease caused by the spirochete Treponema pallidum. The disease can also betransmitted congenitally thereby attaining its importance in antenatal screening. After infection the host forms non-treponemalanti lipoidal antibodies (reagins) to the lipoidal material released from the damaged host cells as well as Treponema specificantibodies. Serological tests for non-treponemal antibodies such as VDRL, RPR, TRUST etc. are useful as screening tests.Tests for Treponema specific antibodies such as TPHA, FTA-ABS, rapid Treponema antibody tests are gaining importance asscreening as well as confirmatory tests because they detect the presence of antibodies specific to Treponema pallidum.

Syphicheck WB is a modified TPHA, which qualitatively detects the presence of IgM and IgG class of Treponema specificantibodies during syphilis in whole blood, serum or plasma specimens within 15 minutes.

Principle

Syphicheck WB utilizes the principle of agglutination of antibodies/ antisera with respective antigen in immuno-chromatography format along with use of nano gold particles as agglutination revealing agent. As the test sample flowsthrough the membrane assembly of the test device , the recombinant Treponema pallidum antigens (47 kDa, 17 kDa) -colloidal gold conjugate forms a complex with Treponema specific antibodies in the sample. This complex moves further onthe membrane to the test region where it is immobilized by the recombinant Treponema pallidum antigens (47 kDa, 17 kDa)coated on the membrane leading to the formation of a pink to deep purple coloured band at the test region 'T’ which confirms apositive test result. Absence of this coloured band in test region ‘T’ indicates a negative test result. The unreacted conjugateand the unbound complex if any, along with rabbit globulin - colloidal gold conjugate move further on the membrane and aresubsequently immobilized by the Agglutinating sera for rabbit globulin coated on the membrane at the control region, forming apink/purple coloured band. This control band serves to validate the test results.

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Introduction

Dengue virus is a flavivirus found largely in areas of the tropic and sub-tropics. There are four distinct but antigenically related serotypes of dengue viruses, and transmission is by mosquito, prinicipally Aedes aegypti and Aedes albopictus. The mosquito-borne dengue viruses (serotype 1-4) cause dengue fever, a severe flu-like illness. The disease is prevalent in third world tropical regions and spreading to sub-tropical developed countries - including the United States. WHO estimates that 50-80 million cases of dengue fever occur worldwide each year, including a potentially deadly form of the disease called dengue haemorrhagic fever (DHF) and dengue shock syndrome (DSS). Primary infection with dengue virus results in a self-limiting disease characterized by mild to high fever lasting 3 to 7 days, severe headache with pain behind the eyes, muscle and joint pain, rash and vomiting. Secondry infection is the more common form of the disease in many parts of Southeast Asia and South America. IgM antibodies are not detectable until 5- 10 days in case of primary dengue infection and until 4-5 days in secondary infection after the onset of illness. IgG appear after 14 days and persist for life in case of primary infection and rise within 1-2 days after the onset of symtoms in secondary infection. This form of the disease is more serious and can result in DHF and DSS. The major clinical symptoms can include high fever, haemorrhagic fever, and circulatory failure, and the fatality rate can be as high as 40%. Early diagnosis of DSS is particularly important, as patients may die within 12 to 24 hours if appropriate treatment is not administered. Primary dengue virus infection is characterized by elevations in specific NS1 antigen levels 0 to 9 days after the onset of symptoms; this generally persists upto 15 days. Earlier diagnosis of Dengue reduces risk of complication such as DHF or DSS, especially in countries where dengue is endemic.

Intended useDengue NS1 Ag Quanti Card is a sensitive immuno- chromatographic test for the qualitative detection of Dengue NS1 Antigen in human Serum/ Plasma with iQuant Analyzer . This test is for in vitro diagnostic use only and is intended as an aid in the earlier diagnosis of dengue infection 

Principle (antigen-antibody reaction)
Dengue NS1 Ag Quanti Card is a fluorescence immunoassay based on sandwich principle. The test area is coated with specific anti-dengue NS1 Ag antibodies. When a sample is added to the cartridge, Dengue NS1 antigen if present will form a complex with another specific NS1 antibodies conjugate to fluorochorme. On addition of Assay Buffer, this complex migrates along the nitrocellulose membrane to the test region and forms an antibody-antigen-antibody fluorescence immunocomplex. The result will be displayed by iQuant Analyzer.

Product Details:

1. Introduction
Dengue virus is a flavivirus found largely in areas of the tropic and sub-tropics. There are four distinct but antigenically related serotypes of dengue viruses, and transmission is by mosquito, prinicipally Aedes aegypti and Aedes albopictus. The mosquito-borne dengue viruses (serotype 1-4) cause dengue fever, a severe flu-like illness. The disease is prevalent in third world tropical regions and spreading to subtropical developed countries - including the United States. WHO estimates that 50-80 million cases of dengue fever occur worldwide each year, including a potentially deadly form of the disease called dengue haemorrhagic fever (DHF) and dengue shock syndrome (DSS). Primary infection with dengue virus results in a self-limiting disease characterized by mild to high fever lasting 3 to 7 days, severe headache with pain behind the eyes, muscle and joint pain, rash and vomiting. Secondry infection is the more common form of the disease in many parts of Southeast Asia and South America. This form of the disease is more serious and can result in DHF and DSS. The major clinical symptoms can include high fever, haemorrhagic evets, and circulatory failure, and the fatality rate can be as high as 40%. Early diagnosis of DSS is particularly important, as patients may die within 12 to 24 hours if appropriate treatment is not administered. Primary dengue virus infection is characterized by elevations in specific NS1 antigen levels 0 to 9 days after the onset of symptoms; this generally persists upto 15 days. Earlier diagnosis of Dengue reduces risk of complication such as DHF or DSS, especially in countries where dengue is endemic.

2. Intended use
DENGUE NS1 Ag MICROLISA is designed for in vitro qualitative detection of Dengue NS1 antigen in human serum or plasma and is used as a screening test for testing of collected blood samples suspected for DENGUE. The kit detects all four subtypes; DEN1, DEN2, DEN3 & DEN4 of Dengue Virus.

3. Principle
Dengue ns1 ag microlisa is a solid phase enzyme linked immunosorbent assay (ELISA) based on the “Direct Sandwich” principle. The microwells are coated with Antidengue NS1antibodies with high reactivity for Dengue NS1 Ag. The samples are added in the wells followed by addition of enzyme conjugate (monoclonal anti-dengue NS1 antibodies linked to Horseradish Peroxidase (HRPO)). A sandwich complex is formed in the well wherein dengue NS1 (from serum sample) is “trapped” or “sandwiched” between the antibody and antibody HRPO conjugate. Unbound conjugate is then washed off with wash buffer. The amount of bound peroxidase is proportional to the concentration of dengue NS1 antigen present in the sample. Upon addition of the substrate buffer and chromogen, a blue colour develops. The intensity of developed blue colour is proportional to the concentration of dengue NS1 antigen in sample. To limit the enzyme-substrate reaction, stop solution is added and a yellow colour develops which is finally read at 450nm spectrophotometrically.

4. Description of symbols used
The following are graphical symbols used in or found on J. Mitra diagnostic products and packing. These symbols are the most common ones appearing on medical devices and their packing. They are explained in more detail in the British and European Standard EN ISO 15223-1:2016.

Product Details:

Carbon Antigen Based Flocculation Test for Detection of Syphilitic Reagin Antibodies in Serum or Plasma.

• Stable, aqueous, ready to use reagents.
• Inactivation of Serum / plasma not required.
• Rapid results within 8 minutes.

Reagent 1: RPR Antigen Suspension 1x10ml
Reagent 2: Positive Control Serum  1 x 0.25ml
Reagent 3: Negative Control Serum 1 x 0.25ml

Product Details:

 The Syphilis Rapid Test Strip is a diagnostic tool designed for the quick detection of syphilis infection, specifically the presence of antibodies (IgM and IgG) against Treponema pallidum, the bacterium that causes syphilis. This test is often used for rapid screening in various settings, including clinics, hospitals, and fieldwork, providing results in a matter of minutes without the need for laboratory equipment.

Additional Information:

• Packaging Details: 50 Strips

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Rapid Test for detection of IgM antibodies to S.Typhiin Serum / Plasma / Whole Blood     

Additional Information:

• Packaging Details: 50 Test

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• Detection of Dengue in the seronegative stage i.e. from Day 1 of fever.

• NS1 assay is useful for differential diagnostics in regards to flaviviruses as there is no cross reactivity

• Detection of all the 4 Dengue serotypes (DEN-1, DEN-2, DEN-3 and DEN-4).

• Results with in 15 minutes

• Detected in acute phase.

• Lessens the window period of detection since can be detected after 1 day after onset of symptoms even before IgM appears.

• In addition to early diagnosis, NS1 Ag may be an indicator of disease severity. A very high concentration of NS1Antigen within 72 hrs. of illness identifies patients at risk of developing DHF or DSS.

• No cross reaction with other flaviviruses.

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The Aspen's HIV Rapid Test Kit is a diagnostic tool used for the rapid detection of HIV antibodies in human serum, plasma, or whole blood samples. This test is designed to detect both HIV-1 and HIV-2 antibodies, which indicate whether an individual has been exposed to the Human Immunodeficiency Virus (HIV). The test is designed for use in healthcare settings, field testing, and other environments where quick results are necessary, and it provides results in 15 to 20 minutes.

Additional Information:

• Packaging Details: 50 DEVICES

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Intended use

The Dengue NS1 Rapid Test is an immunochromatographic assay for the qualitative Detection of non-structural protein 1 (NS1) in human serum/plasma.

Summary and explanation of the test

Dengue is an acute viral disease, which is transmitted by Aedes aegypti mosquitoes. Dengue is characterized clinically by biphasic fever, rash and hematopoietic depression, and by constitutional symptoms such as malaise, arthralgia, myalgia and headache (1). Infrequently, more severe disease is seen, manifested by hemorrhage fever which may progress to lethal shock (2, 3). It is endemic in the tropics and subtropics, worldwide, where an estimated 100,000,000 cases occur annually (4). It has been estimated that about 50 to 100 million cases of Dengue Fever (DF) occur every year with about 250,000 to 500,000 cases of Dengue Hemorrhagic Fever (DHF). During 2002, more than 30 Latin American countries reported over 10,000,000 (DF) cases with large number of DHF cases. This has been followed by extensive epidemics of DHF in several parts of India during 2003 through 2005. In the Americas, the reported incidence has more than tripled from 1996 to 2002. The incidence of Dengue outbreak has been reported in Hawaii (5), and in Laredo, Texas. The potential for the virus to cause a severe disease has also resulted in the inclusion of this pathogen on the CDC “category A” list for potential biological warfare and bioterrorism agents. Dengue NS1 (non-structural) protein is a multimeric secreted protein that is believed to play a role in viral RNA replication. It is strongly immunogenic eliciting antibodies with complement fixing activity. NS1 antigen can be detected in circulating blood during acute Dengue infection. The Aspen Dengue NS1 Rapid Test detects NS1 antigen in serum samples following infection.

Principle of the test

The Dengue NS1 Rapid Test is a qualitative, membrane based immunoassay for the detection of NS1 antigen in human serum/Plasma. The rapid test membrane is pre-coated with a NS1 specific antibody on the test line region and utilizes a separate control to assure assay flow and performance. During testing, the test sample is added directly to the sample region and the test is placed into a well containing 3 drops of buffer. The buffer and serum mix and interact with NS1-specific monoclonal antibodies conjugated to gold nanoparticles. The solution migrates upward on the membrane (via capillary action) to react with the anti-NS1 antibody on the membrane. If NS1 antigen is present, a red line will appear at the test line. The red line at the control region should always appear if the assay is performed correctly.

Kit  storage  and  precautions

The sealed pouch containing the test device and Buffer is designed to be stored at room temperature (22°C-30°C) till the expiry. Exposure to the otemperatures over 30C can impact performance of the test. The kit should not be frozen. The test should be used within 15 minutes after removal from the pouch to prevent exposure to humidity (5 minutes in high humidity areas).

Test  procedure

Remove the  Dengue NS1 Rapid test from the foil pouch and assure that all test serum samples are allowed to reach room temperature.

1. Of to the sample well (s) by using a pipette (or 2 drops of sample by using provided sample dropper).
2. Of buffer in buffer (b)well
3. Read the result after 15 minutes. Do not interpret results  after  30 minutes.

Product Details:

50ml CRP Turbilatex is a liquid reagent used for the quantitative determination of C-reactive protein (CRP) levels in human serum or plasma samples. The test is based on turbidimetric immunoassay methodology, where the presence of CRP in the sample is measured by the change in the turbidity (cloudiness) of the solution when CRP binds to latex particles coated with anti-CRP antibodies.

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The Dengue Test Kit Combo is a diagnostic tool designed to detect Dengue virus infection in individuals. It is typically used to detect both Dengue NS1 antigen and Dengue IgM/IgG antibodies in human serum, plasma, or whole blood samples. This combination of tests allows for early detection of the virus and provides a more comprehensive understanding of the infection’s progression, aiding in diagnosis and treatment decisions.

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A3 Minute Papanicolaou Stain Kit

Product Details:

Rapid Diagnostic test for the detection of Leptospira specific IgM & IgG antibodies in Human Serum/Plasma 

Intended useAdvantage Leptospira IgM & IgG Card is a visual, rapid, sensitive, qualitative immnunoassay for the detection of Leptospira specific IgM and IgG antibodies in human serum or plasma.

Introduction
Leptospirosis is a world-wide occuring zoonotic disease, caused by infection with pathogenic spirochetes of the genus Leptospira. Although traditionally considered as an occupational risk among persons exposed to contaminated water or infected animal urine, leptospirosis is becoming recognised as a common cause of febrile illness in tropical environmments world-wide. The organism enters the human body through cuts or abrasions on the skin or through intact mucosa of the mouth, nose or conjunctiva. The clinical manifestations of leptospirosis range from a mild catarrh like fever, chills, nausea, muscle aches to icteric disease such as Weil’s syndrome, which are charaterized by renal failure, liver impairments & haemorrhages and have a high mortality rate. As clinical symptoms & signs of this infection resemble those of many other infectious diseases including Viral haemorrhage fever and Dengue fever, clinical findings need to be confirmed by laboratory diagnostic techniques.

Principle
(Antigen-antibody reaction) Advantage Leptospira IgM & IgG Card is based on immunochromatographic assay principle. The test uses monoclonal anti-human IgM antibody (test line M) and monoclonal anti-human IgG (test line G) immobilised on a nitrocellulose strip. The test sample is introduced to and flows laterally through an absorbent pad where it mixes with the conjugate. The conjugate contains colloidal gold conjugated to leptospira antigen which is prepared from culture of micro-organisms. If the sample contains Leptospira specific IgM and/or IgG antibodies, it forms a complex with the leptospira antigen gold conjugate making antigen antibodies complex. This complex then migrates through the nitrocellulose membrane by caplillary action. When the complex meets the line of immobilized monoclonal antibodies (Test line, ‘M & G’), it generates a red line, indicating that the sample is reactive. A red procedural control line should always develop at ‘C’ region to indicate that the test has been performed properly

Product Details:

Oscar Dengue antigen (NS-1) test is a rapid card test based upon lateral flow immuno assay for the qualitative detection of NS-1 antigen of Dengue virus in human serum / plasma as in aid of early diagnosis of dengue infection. The nitrocellulose membrane of the test is immobilized with cocktail of monoclonal antibodies of dengue at test line position ‘T’ and goat anti rabbit IgG at control line position ‘C’. The colloidal gold is conjugated with monoclonal antibody of dengue and rabbit IgG. Oscar Dengue antigen (NS-1) test is available in pack of 40 tests and each has four packs each of 10 tests. Each 10 tests pack contains individually pouched test device, sample dropper and product insert. NO buffer is required. Oscar Dengue antigen (NS-1) test has shelf life of 24 months from date of manufacturing if stored at 2-30â??°C in sealed condition

Product Details:

• Detection of NS-1 IgG & IgM antibodies separately and simultaneously : hence suitable for diagnosis of Dengue infection in all stages.

• Detection of all the serotypes DEN 1, DEN2, DEN3 ,DEN4 is possible.

• Fast Results in 15 minutes: Suitable for STAT Diagnosis with whole blood.

• Convenient Procedure & Interpretation: Minimum Chances of procedural errors

• No cross reaction with other flaviviruses for the detection of NS1 antigen.

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Hepalisa Ultra is designed for in-vitro qualitative detection of Hepatitis B Surface antigen (HBsAg) in human serum or plasma and is used as a screening test for testing of collected blood prior to transfusion.

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Intended useDengacheek™ Gombe is a rapid, qualitative immunochromatographic test system for the detection of Dengue NS 1 (DengueNon-Structural Protein-1) antigen and differential detection of IgG & IgM antibodies to Dengue virus in human serum orplasma. The test system can be used as a screening test for Dengue viral infection and as an aid for differential diagnosis of theself-limiting primary Dengue infections and the potentially fatal secondary Dengue infections in conjunction with other criteria.

Summary
Dengue virus (serotypes 1-4} belongs to the family of Flaviviridae, which is widely distributed in the epidemic and endemicareas throughout tropical and subtropical regions of the world. Dengue virus infection is considered significant in terms ofmorbidity, mortality and economic cost associated with it an estimated 100 million cases of dengue fever occurring throughoutthe world yearly. Dengue virus is transmitted in nature principally by the Aedes aegyptfand Aedes albopictus mosquitoes. Themosquito vector is highly domesticated and an urban species. Dengue presents typically as a fever of sudden onset withheadache, retro-orbital pain, pain in the back and limbs (break-bone fever), lymphadenopathy and maculopapular rash.Primary dengue virus infection is characterized by elevation in dengue virus specific NS 1 antigen level in patient's bloodstream from 1-6 days after onset of symptoms. Patients diagnosed with dengue infection in endemic areas generally havesecondary infection, whereas patients in non-endemic areas are usually diagnosed with primary infection. Specific antibodyresponse to Dengue virus enables serodiagnosis and differentiation between primary and secondary dengue infections anddetection of potentially life-threatening conditions such as DHF and DSS.

Principle
Dengacheck™ Combe test kit consists of two devices held in a tray, one device for detection of Dengue NS 4 antigen andsecond device for differential detection of IgG & IgM antibodies to dengue virus in human serum plasma specimen. In both thedevices -Dengue NS 1 antigen and IgG/IgM to dengue virus, the detection system utilizes the principle of agglutination ofantibodies/ antisera with respective antigen in immuno-chromatography format along with use of nano gold particles asagglutination revealing agent. In NS 1 detection device, as the test sample flows through the membrane assembly of thedevice, the highly specific Agglutinating sera for dengue NS 1 - colloidal gold conjugate complexes with dengue NS 1 antigenpresent in the sample and travels on the membrane due to capillary action. The complex moves further on the membrane tothe test region 'T' where it is immobilized by another specific Agglutinating sera for dengue NS 1 coated on the membraneleading to the formation ofa pink-purple band. Absence of this colored band in the test region indicates a negative test result fordengue NS 1/ antigen. In IgG/IgM detection device, as the test sample flows through the membrane assembly within the testdevice, the Dengue specific antigen colloidal gold conjugate complexes with specific antibodies (IgG and/ or IgM) to Denguevirus, if present in the sample. This complex moves further on the membrane to the test region where it is immobilized by thespecific Agglutinating sera for human IgG and/or Agglutinating sera for human IgM coated on the membrane leading toformation of colored band/s which confirms a positive test result. Absence of these colored bands in the test region indicates anegative test result for IgG & IgM antibodies to dengue virus.

Product Details:

Sd bioline dengue NS1 Ag rapid test is an in vitro immunochromatographic, one step assay designed to detect Dengue virus NS1 antigen in human serum, plasma or whole blood.

Benefits

• Diagnosis of early acute dengue infection to detect dengue NS1 antigen
• Dengue NS1 antigen can be detected from the 1st day after onset of fever
• Specimen : Serum, plasma or whole blood (100μl)
• Test result : 15~20 minutes

Product Details:

FERRITINE TET KIT FOR MISPA I2 MACHINE (15 TEST)
Serum ferritin is routinely used as a screen for iron deficiency for a variety of populations like blood donors and people who are receiving regular blood transfusions or iron replacement therapy.

Additional Information:

• Delivery Time: WITHIN 7 DAYS

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Orchid ELISA Kits are diagnostic test kits that use the Enzyme-Linked Immunosorbent Assay (ELISA) technique to detect and quantify specific substances in various biological samples, such as serum, plasma, or urine. Orchid ELISA kits are widely used in clinical diagnostics, biomedical research, and immunology for detecting a variety of biomarkers, such as hormones, infectious agents, autoimmune markers, and tumor antigens. These kits are designed to provide high sensitivity and specificity, making them essential tools in disease diagnosis, monitoring, and research.

Additional Information:

• Packaging Details: 25 Tests

Product Details:

Introduction
Malaria is a serious, sometimes fatal, parasitic disease characterized by fever, chills, and anaemia and is caused by a parasite that is transmitted from one human to another by the bite of infected Anopheles mosquitoes. There are four kinds of malaria parasite that can infect human : Plasmodium falciparum, P. vivax, P. ovale, and P. malariae. As per WHO estimation. in 2012, there were an approximately 207 million cases and an estimated 627 000 deaths . Approximately 90% of all malaria deaths occur in sub-Saharan Africa, and 77% occur in children under 5 years. Malaria remains endemic in 104 countries, and, while parasite-based diagnosis is increasing, most suspected cases of malaria are still not properly confirmed, resulting in over-use of antimalarial drugs and poor disease monitoring. The use of antigen detecting rapid diagnostic tests (RDTs) is a vital part of malaria case management forming the basis for extending access to malaria diagnosis. 

Intended useAdvantage mal card is a visual, rapid, qualitative and sensitive solid phase immuno chromatographic assay based on antigen detection and is as an aid in the qualitative diagnosis of infection with pLDH (Plasmodium Lactate Dehydrogenase) antigen specific to Plasmodium falciparum and other Plasmodium Species (P. vivax / P. malariae / P. ovale) in human whole blood. The kit is intended for professional use and as a screening test. All reactive samples should be confirmed by a supplental assay like microscopic examination of thick smear and thin blood films. It assists trained competent users in detecting plasmodium infections. 

Principle (antigen-antibody reaction)
Advantage mal card is an immunoassay based on the “sandwich” principle. The conjugate contains colloidal gold conjugated to monoclonal anti-pan specific pLDH (Plasmodium Lactate Dehydrogenase) antibody. The test uses monoclonal anti-P.f pLDH antibody (test line F) & monoclonal anti-Pan specific pLDH antibody (test line P) immobilized on a nitrocellulose strip. The test sample is added to the device. On addition of assay buffer, the red blood cells get lysed. If the sample contains P. falciparum and/or P. vivax/P. malariae/P. ovale, the colloidal gold antibody conjugate complexes the P.f. specific pLDH/Pan specific pLDH in the lysed sample. This complex migrates through the nitrocellulose strip by capillary action. When the complex meets the line of the corresponding immobilized monoclonal antibody, the complex is trapped forming a purplish pink band which confirms a reactive test result. Absence of a coloured band in the test region indicates a non-reactive test result. A red procedural control line should always develop at ‘C’ region to indicate that the test has been performed properly

Product Details:

‘oscar corona antibody detection test” is a rapid test kit which is quite simple to use and perform the even at bed side of the patient or at home. A small drop of finger pricked whole blood or Serum / plasma is sufficient to perform the tests and visual results can be obtained within 5 to 20 minutes. It is a qualitative rapid in-vitro diagnostic test which provides the information that whether suspected person has been exposed or not to Covid-19. The test is quite simple to perform in any general healthcare facilities without needs of specialized laboratory technologist and additional equipment. The kit is very stable at room temperature and its storage and transportation will not be an issue as per Indian climate.
The product has been validated and approved by ICMR lab-National Institute of Virology-Pune. As per ICMR report, OSCAR Corona Antibody detection test has sensitivity of more than 97.66 % and specificity of 99%.  

Product Details:

• Immucheck Malraia pf/pv Antigen Rapid Test uses monoclonal antibodies to the P. falciparum specific histidine rich protein- 2 (HRP-2) and Plasmodium vivax specific lactate dehydrogenase (pLDH). Thus, helping in detection and differentiation of malaria by Plasmodium falciparum and vivax. 

• Read clear and reliable rapid results in 20 minutes.

• Uses whole blood, thus can be used as point of care test in any setup.

• Available in 20 and 50 tests package

• Stored at 4-30 ° C

• Ready to use devices

• Offers inbuilt procedural control 

• Approved by WHO

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Product Details:

The Oscar HCV Card is a diagnostic tool used for the rapid detection of antibodies to the Hepatitis C virus (HCV) in human serum, plasma, or whole blood samples. This rapid immunoassay provides a simple and efficient way to screen for HCV infection, particularly in settings where laboratory facilities may not be available or where quick results are required. The test works on the principle of immunochromatography and is designed to detect anti-HCV antibodies, which indicate exposure to the virus.

Product Details:

The Chikungunya Rapid Test Kit is a diagnostic tool designed to quickly detect Chikungunya virus infection. The test is primarily used to detect IgM and IgG antibodies against the Chikungunya virus in human serum, plasma, or whole blood samples. This rapid test is especially useful in areas where Chikungunya is endemic or where outbreaks are occurring, as it provides fast results that can guide treatment and containment efforts.

Product Details:

The HCV Tridot Test Kit is a rapid diagnostic test used for the qualitative detection of antibodies against the Hepatitis C virus (HCV) in human serum, plasma, or whole blood. This immunoassay is designed to detect the presence of anti-HCV antibodies, which are produced by the immune system in response to an HCV infection. The test provides results in 20 minutes, offering a quick and simple method for screening individuals who may have been exposed to HCV.

Additional Information:

• Delivery Time: 1-4 DAYS
• Packaging Details: Available in the pack size of 10 Test & 50 Test

Product Details:

Oscar Chikungunya test is a rapid test based upon immuno-chromatography principle for qualitative detection of IgM & IgG antibodies of Chikungunya in human serum / plasma. The nitrocellulose membrane is immobilized with anti-human IgG, anti-human IgM and control line protein. The colloidal gold conjugate contains recombinant protein of Chikungunya. It is available in pack of 10 test tests. Each kit contains 10 pieces of individually sealed pouches containing test cards, one buffer vial and one piece of product insert. Product has shelf life of 24 months from date of manufacturing if stored at 2-30°C.

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The HCV Test Kit is a diagnostic tool designed to detect Hepatitis C virus (HCV) infection in individuals. This test typically detects anti-HCV antibodies in human blood, serum, or plasma. The presence of these antibodies indicates that a person has been exposed to the virus, though it does not necessarily confirm an active infection. Further testing, such as viral load tests or RNA PCR tests, is often required to determine the presence of the virus and its activity in the body.

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Microwell ELISA Test for the Detection of Antibodies to Hepatitis C Virus in Human Serum/Plasma.

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• Packaging Details: 96 Tests

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The HBsAg ELISA Test Kit is a diagnostic tool used to detect the presence of the Hepatitis B surface antigen (HBsAg) in human serum or plasma samples. HBsAg is a protein present on the surface of the Hepatitis B virus (HBV) and is typically the first detectable marker during an acute HBV infection. Its presence in the bloodstream can also indicate chronic infection or a carrier state in individuals.

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I. HIST Orical review and aetiology of aids (acquired immuno deficiency syndrome)
First confirmed case of Aids was identified in 1983 and by 1984 the etiologic agent, the Human Immunodeficiency Virus (HIV), subsequently named HIV-1 was isolated. Shortly afterwards in 1985 another retrovirus subsequently named HIV-2 was isolated in Africa. These two viruses belong to the retrovirus group and are slow viruses. The structure, gene organisation and serological behaviour of HIV-1 & HIV-2 and their complete nucleotide sequence has been determined. This knowledge has laid a foundation for the development of a new assay based on Recombinant DNA technology leading to the differential detection of antibodies to HIV-1 & HIV-2 (if present) in Human Serum or Plasma. Research has shown that antibodies produced against envelope gene are found in infected people as shown in graph, (Fig.-1).

HIV TRI-DOT has been developed and designed using gp41, C terminal of gp120 & gp36 representing the immunodominant regions of HIV-1 & HIV-2 envelope gene structure respectively. The device (an immunofiltration membrane) includes a "Built-in Quality Control DOT" which will develop colour during the test, thereby, confirming proper functioning of the device, reagents and correct procedural application. This Control dot is the "Built-in Quality Control." (Fig.2) HIV TRI-DOT has been specially researched, developed and engineered using several thousands of serum/plasma specimens. It has also been evaluated by UNAIDS (WHO) Geneva, using samples of European, Asian, Latin American & African origin. The Sensitivity and Specificity has been extremely high in these samples of diverse origin. The panel used for evaluation of HIV TRI-DOT by Institute of Tropical Medicine, WHO Collaborating Centre in AIDS, Belgium also included HIV-O Virus, which was found reactive with HIV TRI-DOT.

2. Intended use 

The HIV TRI-DOT Test is a visual, rapid, sensitive and accurate immunoassay for the differential detection of HIV-1 & HIV-2 antibodies (IgM, IgG & IgA) in Human Serum or Plasma using HIV-1 & HIV-2 Antigens immobilized on an immunofiltration membrane. The test is a screening test for anti-HIV-1 & antiHIV-2 and is for in vitro diagnostic use only.

3. Description of symbols used
The following are graphical symbols used in or found on J. Mitra diagnostic products and packing. These symbols are the most common ones appearing on medical devices and their packing. They are explained in more detail in the British and European Standard EN ISO 15223-1:2016.

4. Principle of the test
HIV antigens are immobilized on a porous immunofiltration membrane. Sample and reagents pass through the membrane and are absorbed into the underlying absorbent. As the patient''s sample passes through the membrane, HIV antibodies, if present, bind to the immobilized antigens. Conjugate binds to the Fc portion of the HIV antibodies to give distinct pinkish purple DOT(s) against a white background. (Fig.-3)