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Immunoassay Reagents

INTENDED USE The Finecare™ 2019-nCoV lgM/lgG Test is a fluorescence immunoassay used along with Finecare™ FIA Meters for qualitative detection of IgG and IgM antibodies of novel coronaviruses (2019-nCoV) in human whole blood, serum and plasma specimen. Clinically, the test is to be used as an aid in the diagnosis of coronavirus infection disease (COVID-19), which is caused by 2019-nCoV. The test provides preliminary test results. Negative results cannot exclude the possibility of 2019-nCoV infection and they cannot be used as the sole basis for treatment or other management decision. STORAGE AND STABILITY 1. Store at 4-30°C in the sealed pouch up to the expiration date printed on the package. Do not freeze. 2. The test device should be used within 1 hour after taking out from the foil envelope. 3. Keep away from sunlight, moisture and heat. 4. Kit contents are stable until the expiration date printed on the outer box.

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Rapid Test

Intended Use Advantage Dengue NS1 Ag card is a rapid solid phase Immuno-chromatographic test for the qualitative detection of Dengue NS1 Antigen in Human serum /Plasma.This test is for in vitro diagnostic use only and is intended as an aid in the earlier diagnosis of Dengue Infection. Salient Features Rapid test based on lateral flow technique. Detection of Dengue in the seronegative stage i.e. from Day 1 of fever. Detection of all the 4 Dengue serotypes (DEN-1, DEN-2, DEN-3 and DEN-4). Results with in 20 minutes Longer shelf life : 30 months at 2-30°C. Convenient pack size : 25 tests Sensitivity-96% and Specificity- 98%

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Rapid Test

Intended Use The 4th Generation HIV TRI-DOT + Ag test is a visual, rapid, sensitive and accurate immunoassay for the differential detection of HIV-1 p24 antigen and HIV-1 & HIV-2 antibodies (IgM,IgG & IgA) in Human Serum or Plasma. The test is a screening test for p24 antigen (HIV-1), anti-HIV-1 & anti-HIV-2 and is for in vitro diagnostic use only. It is intended for screening of blood donors or other individuals at risk for HIV-1 & HIV-2 infection and for clinical diagnostic testing. Salient Features Rapid visual test ,based on enzyme immuno assay & Flow Through Technology. Rapid test for simultaneous and differential detection of p24 Antigen & antibodies for HIV on the same device. Ideal for Blood screening: detects sero-negative HIV Cases. Use of gp-41, C terminus of gp120 for HIV-1 antibodies & gp-36 for HIV -2 antibodies. Detection of Group ‘0’ & subtype ‘C’ of HIV-1, which is most prevalent in India. Unique washing steps for clear Interpretation of Results. Evaluated by National Institute of Biologicals- 100 % Sensitivity & 100 % Specificity. Long Shelf life: 15 months at 2-8° C.

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Rapid Test

Intended Use HIV Ag & Ab Card (4th Generation) is a visual, rapid qualitative and sensitive solid phase immunochromatographic assay for the differential detection of HIV-1 p24 Antigen and Antibodies (IgM, IgG & IgA) to HIV-1& HIV-2 in Human Serum/ Plasma/ Whole blood (collected by venipuncture or Fingerprick). The test is a screening test for p24 antigen (HIV-1) and HIV antibodies (anti-HIV-1 & anti-HIV-2) and is for in vitro diagnostic use only. It is intended for screening of blood donors or other individuals at risk for HIV-1 & HIV-2 infection and for clinical diagnostic testing. It is a screening test for p24 antigen (HIV-1) and HIV antibodies (anti-HIV-1 & anti-HIV-2). The test is for in vitro diagnostic use only and is intended for screening of blood donors or others individuals at risk for HIV-1 and/or HIV-2 infection and for clinical diagnostic testing. Salient Features • Finger prick, rapid, visual and qualitative Immunoassay. • 4TH Generation Rapid test for differential detection of p24 Antigen & antibodies for HIV in serum/plasma /whole blood. • Ideal for Blood screening, detects sero-negative HIV Cases. • Use of gp-41, C terminus of gp120 for HIV-1 , gp-36 for HIV -2 antibodies and Anti-p24 for HIV p24 Ag detection. • Detection of Group ‘0’ & subtype ‘C’ of HIV-1, which is most prevalent in India. • Based on Immunochromatography Technique. • See through device for easy interpretation of results. • Sensitivity : 100 % & Specificity: 100% • Analytical Sensitivity of HIV p24 Ag : 100 IU/ml (traceable to p24 Antigen NIBSC Standard, U.K. Code No. 90/636) • Long Shelf life 30 months at 2-30°C • Convenient pack size: 25 T.

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Instruments

The new and improved RTR-1 uses an image processing method. During measurement, the lateral flow device is captured using a 5-mega pixel camera and the picture is analyzed using image processing algorithms for identification of either presence or absence of test line bands or test line band intensity levels. The reader converts the image into a grayscale and then classifies the intensity levels of the image in 0 to 255 grayscale range. The image processing algorithm undergoes various levels of filtering and segmentation to yield the correct intensity levels from the picture. Based on the preconfigured intensity levels, the reader classifies the band intensity and reads out the results as either positive or negative. ACCURACY: Less than 3% intra-run CV Eliminates subjective interpretation by operator FLEXIBILITY: Single mode for low volume test setting Batch mode allows for high volume test setting Result output as semi-quantitative line intensity and visual image EASE-OF-USE: Built in barcode reader provides faster test setup Touch screen interface for easy operation Lightweight (0.7kg) and portable DATA MANAGEMENT: Results presented on screen, on a printout or uploaded to reader database Storage capacity of 1,000 test results (including images) Laboratory Information System (LIS) and Wi-Fi compatible Human Machine Interface 4-inch resistive touch screen Camera 5 mega pixel CMOS camera Barcode Scanner Integrated 1 dimensional barcode scanner Printer 48 mm inbuilt thermal printer Mode Single mode and batch mode operations Port/USB Data export and software upgrade through 2 USB ports Storage Storage capacity of 1000 test results (including images) Result output “Positive or Negative” as well as quantitative test line intensity Power 12V 2A Processor ARM Cortex-A53 Platform Embedded Linux Dimension 220 mm X 170 mm X 110 mm (L x B x H) Weight 0.7 kg (Approx CATALOG # PRODUCT RTR-1 Rapid Test Reader OTHER PRODUCTS YOU MIGHT BE INTERESTED IN.. CATALOG # PRODUCT ADX-110 ELISA Reader ADX-120 Microplate Washer

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Rapid Test

Buy AccuTest COVID-19 IgG/IgM Rapid Test (Pack of 10 Tests) Online. COVID-19 IgG/IgM Rapid Test Kit is a qualitative immuno chromatographic assay for the detection of IgG & IgM antibodies produced against COVID-19 virus in human whole blood/Serum/ Plasma. COVID-19 IgG/IgM Rapid Test Kit is only intended for initial screening and reactive samples should be confirmed by a supplemental assay. Intended Use: COVID-19 IgG/IgM Rapid Test Kit is a qualitative immuno chromatographic assay for the detection of IgG & IgM antibodies produced against COVID-19 virus in human whole blood/Serum/ Plasma. COVID-19 IgG/IgM Rapid Test Kit is only intended for initial screening and reactive samples should be confirmed by a supplemental assay. SUMMARY & TEST DESCRIPTION: COVID-19 [Coronavirus Disease- 2019] is an infectious disease caused by SARS-CoV2 [Severe Acute Respiratory Syndrome coronavirus 2] virus, which is a contagious, novel strain of CoronaVirus that emerged from Wuhan, China in December 2019, which grew as a pandemic threatening human survival across the globe. The virus is thought to be of zoonotic origin and likely to have spread from large seafood and animal markets by human-animal contact in the city of Wuhan, where consumption of such products is in large. The virus causes respiratory infection with symptoms including fatigue, fever, shortness of breath, respiratory failure, renal failure and death. Patients can become infected with SARS-CoV-2 virus by person-person contact (through contact with a contaminated environment or person). The young and old (and other immune-compromised individuals) are most at risk of serious complications; however, approximately 20% of those infected can develop a critical condition. COVID-19 IgG/IgM Rapid Test device utilizes Anti-human IgG and Anti-human IgM antibodies as the capture molecules. COVID-19 Recombinant Antigens-colloidal gold conjugate are used as detection antigen. Intended Use: COVID-19 IgG/IgM Rapid Test Kit is a qualitative immuno chromatographic assay for the detection of IgG & IgM antibodies produced against COVID-19 virus in human whole blood/Serum/ Plasma. COVID-19 IgG/IgM Rapid Test Kit is only intended for initial screening and reactive samples should be confirmed by a supplemental assay. SUMMARY & TEST DESCRIPTION: COVID-19 [Coronavirus Disease- 2019] is an infectious disease caused by SARS-CoV2 [Severe Acute Respiratory Syndrome coronavirus 2] virus, which is a contagious, novel strain of CoronaVirus that emerged from Wuhan, China in December 2019, which grew as a pandemic threatening human survival across the globe. The virus is thought to be of zoonotic origin and likely to have spread from large seafood and animal markets by human-animal contact in the city of Wuhan, where consumption of such products is in large. The virus causes respiratory infection with symptoms including fatigue, fever, shortness of breath, respiratory failure, renal failure and death. Patients can become infected with SARS-CoV-2 virus by person-person contact (through contact with a contaminated environment or person). The young and old (and other immune-compromised individuals) are most at risk of serious complications; however, approximately 20% of those infected can develop a critical condition. COVID-19 IgG/IgM Rapid Test device utilizes Anti-human IgG and Anti-human IgM antibodies as the capture molecules. COVID-19 Recombinant Antigens-colloidal gold conjugate are used as detection antigen. PRECAUTIONS & WARNING 1. This package insert must be read completely before performing thetest. Failuretofollow directions in insert may yield inaccurate test results. 2. Test results should be read between 10 and 15 minutes after aspecimenisapplied to the sample well. Results read after 20 minutes may giveerroneousresults.3. Do not open the sealed pouch until you are ready to conduct theassay.Onceopened, the cassettes should be used immediately. 4. Do not use expired devices. 5. Bring all reagents to room temperature (15-30°C) prior to use. 6. Do not mix components from different kits. Use only the buffer suppliedalongwith the kit. 7. Wear protective clothing and disposable gloves while handling thekit reagentsand clinical specimens. Wash hands thoroughly after performing thetest. 8. Do not smoke, drink, or eat in areas where specimens or kit reagents arebeinghandled. 9. Dispose of all specimens and materials used to performthe test as biohazardouswaste. 10. Handle the negative and positive controls in the same manner as patientspecimens for operator protection. 11. Do not perform the test in a room with strong air flow, i.e. an electricfanorstrong air-conditioning. 12. Do not touch result window. 13. Use only for in-vitro diagnostic purpose.

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Rapid Test

Buy AccuTest Typhoid IgG/IgM Rapid Card Test (5 Tests) Online from Accurex. The Typhoid IgG/IgM Rapid Test is used for detection & differentiation of anti-Salmonella typhi (S. typhi) IgG and IgM in human whole blood / serum / plasma. This Typhoid test is used as a screening test and as an aid in the diagnosis of infection with S. typhi. Salmonella typhi bacteria causes typhoid Typhoid fever, typhoid symptoms symptoms are likely to develop gradually – appearing one to three weeks after exposure to the disease. There are various typhoid treatment & typhoid vaccine which can be opted after the detetction of Typhoid. Typhoid fever is caused by S. typhi, a Gram-negative bacterium. Worldwide an estimated 17 million cases and 600,000 associated deaths occur annually. Patients who are infected with HIV are at significantly increased risk of clinical infection with S. typhi. Evidence of H. pylori infection also presents an increased risk of acquiring typhoid fever. 1-5% of patients become chronic carrier harboring S. typhi in the gall bladder. The clinical diagnosis of typhoid fever depends on the isolation of S. typhi from blood, bone marrow or a specific anatomic lesion. In the facilities that can not afford to perform this complicated and time-consuming procedure, Filix-Widal test is used to facilitate the diagnosis. However, many limitations lead to difficulties in the interpretation of the Widal test. In contrast, the Typhoid IgG/IgM Rapid Test is a simple and rapid laboratory test. The test simultaneously detects and differentiates the IgG and the IgM antibodies to S. typhi specific antigen thus to aid in the determination of current or previous exposure to the S. typhi. PRINCIPLE The Typhoid IgG/IgM Rapid Test is a lateral flow immunochromatographic assay. The test cassette consists of: 1) a pink-purple colored conjugate pad containing recombinant S. typhi H antigen and O antigen conjugated with colloid gold (Typhoid conjugates) and rabbit IgG-gold conjugates, 2) a nitrocellulose membrane strip containing two test region (Test line M and G) and a control region (control line). The test line ‘M’ is pre-coated with monoclonal anti-human IgM for the detection of IgM anti-S. typhi, test line ‘G’ is pre-coated with monoclonal anti-human IgG for the detection of IgG anti-S. typhi , and the C band is pre-coated with goat anti rabbit IgG. When an adequate volume of test specimen is dispensed into the sample well of the cassette, the test specimen migrates by capillary action across the test cassette. Anti-S. typhi IgM if present in the patient specimen will bind to the Typhoid conjugates. The immunocomplex is then captured on the membrane by the pre-coated anti-human IgM antibody at test region ‘M’, forming a pink-purple line at ‘M’ region, indicating a S. typhi IgM positive test result. Anti-S. typhi IgG if present in the patient specimen will bind to the Typhoid conjugates. The immunocomplex is then captured by the pre-coated reagents on the membrane, forming a pink-purple line at test region ‘G’, indicating a S. typhi IgG positive test result. Absence of any pink-purple line at test region (M and G) suggests a negative result. The test contains an internal control (control line) which should exhibit a pink-purple line of the immunocomplex of goat anti rabbit IgG/rabbit IgG-gold conjugate regardless of the color development on any of the test region. Otherwise, the test result is invalid and the specimen must be retested with another device. PRECAUTION 1. This package insert must be read completely before performing the test. Failure to follow the insert gives inaccurate test results. 2. Do not open the sealed pouch, unless ready to conduct the assay. 3. Do not use expired devices. 4. Bring all reagents to room temperature (15°C-30°C) before use. 5. Do not use the components in any other type of test kit as a substitute for the components in this kit. 6. Do not use hemolized blood specimen for testing. Wear protective clothing and disposable gloves while handling the kit reagents and clinical specimens. Wash hands thoroughly after performing the test. 7. Users of this test should follow the US CDC Universal Precautions for prevention of transmission of HIV, HBV and other blood-borne pathogens. 8. Do not smoke, drink, or eat in areas where specimens or kit reagents are being handled. 9. Dispose of all specimens and materials used to perform the test as biohazardous waste. 10. Handle the Negative and Positive Control in the same manner as patient specimens. 11. The testing results should be read within 15 minutes after a specimen is applied to the sample well or sample pad of the device. Read result after 15 minutes may give erroneous results. 12. Do not perform the test in a room with strong air flow, ie. an electric fan or strong air-conditioning. Other Info STORAGE AND STABILITY Typhoid IgG/IgM test card should be stored at 4-40°C. The card may be stored at room temperature but not exceeding 40°C in the original sealed pouch. The shelf life or expiry of the card is printed on Pouch as well as carton label. The test kit should be kept away from direct sunlight, moisture and heat.

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Rapid Test

Buy AccuTest Syphilis Rapid Card Test (50 Tests) Online from Accurex. This Syphilis test is a special test kit designed to detect Syphilis (Treponema Pallidum- IgA, IgM, IgG) antibodies in serum/plasma. Syphilis is caused by the bacterium Treponema pallidum. There different types of test like VDRL test, RPR test, FTA-ABS, etc. AccuTest Syphilis Test Kit is easy to use at home and gives you 99% accurate result in just 5 -20 minutes, with sensitivity & specificity of 99.67%. Recombinant syphilis antigen (17KDa, 15KDa, 47KDa) is immobilized in the lest line region of the device. AccuTest Syphilis Rapid Test is a special test kit designed to detect Syphilis (Treponema Pallidum- IgA, IgM, IgG) antibodies in serum/plasma. This kit is easy to use at home and gives you 99% accurate result in just 5 -20 minutes, with sensitivity and specificity of 99.67%. 1. AccuTest Syphilis is a chromatographic immunoassay kit for rapid qualitative detection of Treponemal antibodies (IgA, IgM, IgG) generated against Treponema pallidum Antigens (17KDa, 15KDa, 47KDa) in human serum or plasma with high sensitivity and specificity. 2. Results just in 5-20 minutes 3. Accu Test Syphilis exhibits sensitivity and specificity of 99.67%. Features: Based on Chromatographic Immunoassay assay for detection of Treponema pallidum antigens Sample: Human Serum or Plasma 2-3 drops of Serum/Plasma sample required for testing Fast: 1 step method, result in just 5 to 20 minutes Excellent sensitivity and specificity of 99.67% Store unused kit at 2-30C Pack size: 50 T Recombinant syphilis antigen (17KDa, 15KDa, 47KDa) is immobilized in the lest line region of the device. After the specimen is added to the specimen well in the device, it reacts with syphilis antigen coated particles in the test. The mixture migrates chromatographically along the length of the test strip and interacts with the immobilized syphilis antigen. The double antigen test format can detect IgA, IgG & IgM in specimens. If the specimen contains TP antibodies a coloured band will appear in the lest line region indicating a positive result. In the absence of TP antibodies a coloured band will not appear in the region indicating a negative result. To serve as a procedural control, a coloured band will always appear in the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred. Based on Chromatographic Immunoassay assay for detection of Treponema pallidum antigens Sample: Human Serum or Plasma 2-3 drops of Serum/Plasma sample required for testing Fast: 1 step method, result in just 5 to 20 minutes Excellent sensitivity and specificity of 99.67% Store unused kit at 2-30C Pack size: 50 T Direction for Use Procedure: 1. Bring the pouch to room temperature before opening to avoid condensation of moisture on the membrane of the device. Also bring the specimen to R.T. prior to testing. 2. Label the device with patient’s identification. 3. Add 2-3 drops (approx. 30 pl) of sample into the sample well of the test device. Avoid overflowing. 4. Wait for 5 – 20 minutes and read the result. It is important that the background is clear beforg the result is read. Note: Do not read the result after 30 minutes since specimen back flow may cause false result. STORAGE, STABILITY & HANDLING 1. The kit should be stored at 2 – 30° C. Do not freeze. 2. Do not use the kit past the expiration date stated on label. 3. Take off the device from the sealed pouch just before use as the device is sensitive to humidity and heat.

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Rapid Test

Buy AccuTest HCV Rapid Card Test (30 Tests) Online from Accurex. HCV means Hepatitis C Virus which is a is a small, enveloped, positive-sense, single-stranded RNA virus. Hepatitis C symptoms are fever, fatigue, decreased appetite, nausea, vomiting, abdominal pain, dark urine, pale feces, joint pain and jaundice. HCV test is a rapid Chromatographic Immunoassay work on principle of the double antigen sandwich technique, Qualitative detection of antibodies generated against proteins that are encoded by conserved sequence of core NS3, NS4, NS5 parts of HCV genome in human whole blood/serum or plasma. AccuTest HCV Test is a rapid Chromatographic Immunoassay for the Qualitative detection of antibodies generated against proteins that are encoded by conserved sequence of core NS3, NS4, NS5 parts of HCV genome in human whole blood/serum or plasma. Hepatitis C Virus (HCV) is a small, enveloped, positive-sense, single-stranded RNA virus. Antibody to HCV is found in over 80% of patients with well documented non-A, non-B hepatitis. Conventional methods fail to isolate the virus in cell culture or visualize it by electron microscope. Cloning the viral genome has made it possible to develop serologic assays that use recombinant antigen, multiple antigens using recombinant protein and/or synthetic peptides have been added in new serologic tests to avoid nonspecific cross-reactivity to increase the sensitivity of HCV antibody tests. Storage and Stability: AccuTest HCV should be stored at 4-30C. However, the card may be stored at room temperature not exceeding 30C in the original sealed pouch. Test Procedure: 1. Allow the test, specimen and or control to room temperature prior to the testing 2. Remove one test card from the pouch and place it on a clean flat surface 3. Using the dropper provided one drop of serum/plasma or W. blood sample (30ul) then two drops of buffer (40ul) immediately into the sample well. Avoid overflowing 4. Read results within 15 minutes. Strong positive reaction may visible within 5 minutes. Do not read results after 15 minutes. 5. If negative or quest Principle: AccuTest HCV Rapid Hepatitis C Virus Test (Serum/Plasma/Whole Blood) is a lateral flow chromatographic immunoassay based on the principle of the double antigen-sandwich technique. The membrane is coated with recombinant HCV antigen on the test line region of the device. During testing, the serum/plasma or W.Blood specimen reacts with HCV antigen coated particles. The mixture migrates upward on the membrane chromatographically by capillary action to react with recombinant HCV antigen or membrane and generate a colored line. Presence of this colored line indicates a positive result, while its absence indicates a negative result. To serve as a procedural control, a colored line will always appear at the control line region, indicating that the correct volume of specimen has been added and membrane wicking has occurred. Storage and Stability: AccuTest HCV should be stored at 4-30C. However, the card may be stored at room temperature not exceeding 30C in the original sealed pouch. Test Procedure: 1. Allow the test, specimen and or control to room temperature prior to the testing 2. Remove one test card from the pouch and place it on a clean flat surface 3. Using the dropper provided one drop of serum/plasma or W. blood sample (30ul) then two drops of buffer (40ul) immediately into the sample well. Avoid overflowing 4. Read results within 15 minutes. Strong positive reaction may visible within 5 minutes. Do not read results after 15 minutes. 5. If negative or questionable results are obtained, the HCV infection is suspected, the test should be repeated ona fresh serum specimen. Safety Information •Positive: If a distinct purple line is formed at the test one marked ‘T’ (Test Line) and the Control Zone marked ‘C’ (Control Line) the test result is positive, indicating the sample contains Hepatitis C antibody. The interpretation of test results (+ve for hepatitis) remains unchanged even if there is a difference in intensity of color in positive line and control line as is many a time found. •Negative: If a distinct purple line is formed only at the control zone marked ‘C’ (control line) the test result is negative • Invalid: A total absence of color in both © and (T) regions or no colored band appears on the control © region is an indication of procedure error and/or the test reagent has deteriorated. Repeat with a new test kit. Direction for Use Test Procedure 1. Allow the test, specimen and or control to room temperature prior to the testing 2. Remove one test card from the pouch and place it on a clean flat surface 3. Using the dropper provided one drop of serum/plasma or W. blood sample (30ul) then two drops of buffer (40ul) immediately into the sample well. Avoid overflowing 4. Read results within 15 minutes. Strong positive reaction may visible within 5 minutes. Do not read results after 15 minutes. 5. If negative or questionable results are obtained, the HCV infection is suspected, the test should be repeated ona fresh serum specimen. Other Info Storage and Stability AccuTest HCV should be stored at 4-30C. However, the card may be stored at room temperature not exceeding 30C in the original sealed pouch.

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