BC-6800 Today, laboratories not only need more reliable routine CBC plus 5-part diff WBC testing by way of high processing speed, but are also looking for options that extend the analyzer's output in form of Reticulocytes, Nucleated RBCs, Fluorescent Platelet counts etc. for wider clinical application and research. On the other hand, they are restricted by limited budgets. BC-6800 can help to meet all these needs just perfectly and even exceed the expectations. Additional parameters for further clinical applications IMG(#,%) parameters provide information about immature granulocyte, including promyelocytes, myelocytes and metamyelocytes. HFC*(#,%) parameters represent high fluorescent cell population, such as blasts and atypical lymphocytes. RET(#,%) extend valuable help in the differential diagnosis and/or therapeutic monitoring of anemias. IRF is parameter concerning immature reticulocytes, which can assist in early diagnosis of anemia and monitoring the bone marrow response to therapy. InR*(#,‰) are parameters regarding infected red blood cell. The red blood cells may infected by plasmodium, which can cause malaria. * means research parameters SF Cube Technology SF Cube is a pathbreaking technology for reliable blood cell analysis, including WBC differential, Reticulocytes and NRBC with efficient flagging. After reaction with proprietory reagents, the targeted blood cells undergo 3D analysis using information from scatter of laser light at two angles and fluorescence signals. The 3D scattergram builds the power to better identify and differentiate blood cell populations, especially to reveal abnormal cell population undetected by other techniques. Minimizing interference to ensure more accurate results NRBCs are counted in a dedicated channel by SF cube method, which automatically corrects total WBC count and 5-part Diff results when NRBCs are detected. The Focusing Flow-DC method minimizes the interference traditionally encountered in DC technology to produce near gaussian histograms. PLT-O result avoids the interference from microcytic and fragmented RBCs, large platelets and/or platelet clumps by fluorescent stain, and enhances the results accuracy and sensitivity. High automation to minimize the workload Throughput for 125 tests/hour, autoloader for 100 sample tubes capacity Bi-directional LIS with HL7 or ASTM communication protocol Customizable re-exam rules allow users to define their re-exam criterion according to lab’s practice

n large laboratories, rows of instruments are seen working tirelessly like miniature factories – only they produce not commodities but medical test results. Mindray CAL 8000 new-generation cellular automation line is one of them, but unlike a typical workhorse, it is intelligent. It is a highly automated workstation for smarter, faster, and more accurate cellular analysis. It can perform competently in the face of these challenges. The workstation can hold up to four units of BC-6800 automated hematology analyzer, which utilizes the advanced SF Cube technology and 3-D scatter grams to help doctors better differentiate blood cell populations and reveal abnormal cells undetectable by conventional techniques. With 125 CBC tests per hour per unit, BC-6800 brings the process rate of the workstation to 20–30 percent higher than other similar models, effectively alleviating laboratory's stress during the peak processing hours. On CAL 8000, the hematology analyzer, slide maker and stainer, CRP analyzer, and HbA1c analyzer are all integrated into one seamless production line through automated track modules and trolley. Simply by loading a single tube of blood sample onto the automation system, one can get all the test results. This innovative walk-away automation functionality has made possible the CBC+CRP+HbA1c testing all in one streamlined workstation for the first time in the industry. It offers a smart solution, or rather, a smart expert – the labX pert 2.0. It is a software that can automatically sort out the suspected samples for manual validation. The pathologist then decides if rerun or microscopic review is warranted based on their clinical experience. It avoids wasting slides and reduces extra work. Moreover, the onboard automated re-exam functionality also helps enhance work efficiency. The CMU software The touch screen is the “brain” of CAL 8000. It optimizes the distribution of workload between each analyzer unit and decides which sample requires a blood smear. It displays the status of each analyzer or SC-120 installed on CAL 8000 as well as the volume of balance reagent. This intuitive software can tell the users all necessary information of CAL 8000 at any given time. Consequently, the users spend less time operating CAL 8000 and can arrange their working schedule better. Multi “R” tests The CAL 8000 can automatically distribute the samples with “Repeat”, “Rerun” and “Reflex” criteria which are pre-defined by users.The re-exam criteria on CAL 8000 can be defined by many conditions, such as time, patient’s age, gender, department, etc. This helps minimize the number of blood smears. Special tube racks The special tube racks utilize different barcodes to differentiate specific testing purposes, such as “QC”, “Slide making & staining only” and “RET test only”. The special tube racks can carry the tubes to perform these specific functions in the simplest way.

Palm-sized, fitting easily into a doctor's bag or uniform pocket. The printer can be separated from the "PocketChem" analyzer, leaving it with a weight of just 180g. Corrective features for obtaining accurate test results Accurate readings can be obtained by eliminating the effects of chromaturia using the color correction test pad, by compensating measurements for the temperature of the surrounding environment using a built-in temperature sensor and by correcting specific gravity based on pH readings. Palm-sized analyzer driven by two batteries The analyzer is detachable from the printer. The analyzer is really portable and mobile. Simple operation. Just press the start button Measurement is performed by simply pressing the start button and placing a test strip. Test results can be simultaneously viewed on the display and printed out from the printer. Reliable test results with Creatinine correction Even with the use of spot urine, test results are reliable and are not affected by urine dilutions or concentrations. The P/C ration or A/C ratio is effective for the screening of renal diseases. Sample Urine Test strips AUTION Sticks/ Uriflet S (9UB)* / AUTION SCREEN * Except devices with 10V specifications Measurement items GLU (glucose), PRO (protein), BIL (bilirubin), URO (urobilinogen), S.G. (specific gravity), BLD (blood), PH (pH), KET (ketones), NIT (nitrite), LEU (leukocytes), CRE (creatinine) and ALB (albumin). Measurement principle Test strip: Dual wavelength reflectance method. (one wavelength for BLD measurement) Measurement wavelengths 3 wavelengths LED (565, 635, 760 nm) Sample supply method Manual dipping Measurement capacity 50 tests per hour Test strip reaction time About 60 seconds per test Measurement types Normal measurement and check measurement Display Custom LCD that displays information including type of test strip, measurement number (up to 4 digits), patient ID (up to 13 digits) and test results. Operator panel Panel sheet that provides 14 buttons including numeric buttons and start button. Memory capacity Test results for 100 samples External output Compliant with RS-232 C Measurement environment Temperature: 10 to 30 °C; Humidity: 30 to 60 % R.H. (non-condensing) *Temperature correction function used Dimensions 124 (W) x 81 (D) x 36 (H) mm Weight 180 g (without batteries) Power supply Instrument only: Two AA alkaline batteries or AC adapter Instrument with printer: AC adapter 7.5 V 3 A Power consumption 3 W Printer specifications Printer Thermal recording printer Printer paper High color development thermal paper (W 58 mm x φ26 mm) Dimensions 125 (W) x 133 (D) x 36 (H) mm Weight 180 g (without printer paper) Power supply AC adapter 7.5 V 3 A Power consumption 20 W

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.

Buy AccuTest Vitamin D Rapid Card Test (10 Tests) Online from Accurex. The Vitamin D test kit consists of 25 AccuTest Vitamin D individually packed test, devices in foil pouches, 25 pipettes for collecting 10 ul of whole blood, 25 lancets, 1 Buffer Vial (Buffer 5 mL) with stabilizers and, thimerosal, 1 Package Insert. Vitamin D Fast test kit is a rapid chromatographic immunoassay for the semi quantitative detection of Vitamin D levels in human blood/serum. This Vitamin D test provides a preliminary screening test result. INTENDED USE AccuTest Vitamin D is a rapid chromatographic immunoassay for the semi quantitative detection of Vitamin D levels in human blood/serum. This assay provides only a preliminary screening test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. The performance characteristics of this assay have not been established in a pediatric population. PRINCIPLE AccuTest Vitamin D is based on the principle of a competitive enzyme immunoassay. The assay is based on the competition for 25-OH Vitamin D present in blood/serum sample and Vitamin D present on the test line for fixed number of antibody-gold conjugate. Depending upon the concentration of Vitamin D in blood/serum, there will be free antibody-gold conjugate molecules that will bind to Vitamin D on the test strip and will show a colored line in the test line zone. A control line is present in the test window to work as procedural control. PRECAUTIONS 1. For in vitro diagnostic use only. 2. The test is designed for use with human blood/serum only. 3. Reagents must be at room temperature (8⁰C – 30 ⁰C). 4. Do not use if test device packaging is open or damaged. 5. Do not use the product beyond expiration date. 6. Handle all specimens as potentially infectious. Proper handling and disposal methods should be used according to good laboratory practices. 7. Read test results for 10 minutes as required. Results may deteriorate and may not be consistent after 10 minutes. 8. In order to avoid variable results, mix the blood sample thoroughly. 9. A serum sample subjected to repeated freeze thaw cycles may give variable results Direction for Use PROCEDURE 1. Remove the cassette from the sealed pouch and place it on a hard flat surface with the view window facing up (use the cassette as soon as possible). 2. Using a micropipette, add 10 µl of whole blood or 5ul of serum sample directly into the rectangular specimen well (marked with Red drop) of the cassette. 3. Add 3 full drops of Buffer into the square buffer well of the cassette (Do not move the cassette after addition of buffer). 4. Let the cassette sit for 10 minutes and read your results immediately. Results may deteriorate after the 10 minute mark. Other Info STORAGE AND STABILITY The test device should be stored at 8 ⁰C – 30 ⁰C and will be stable until the expiration date stated on the package. The product is humidity sensitive and should be used immediately after being open. INTERPRETATION OF RESULTS Match the color of the test line with the chart provided.

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.

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.

Buy AccuTest Malaria Pf(HRP II)/Pv Rapid Card Test (50 Tests) Online from Accurex. This Malaria test is a rapid qualitative, chromatographic immunoassay for the detection of malaria infection in human blood sample indicating differential diagnosis between Plasmodium falciparum and Plasmodium vivax species. This Malaria parasite test kit has test strips coated with Monoclonal Anti-p LDH antibodies (test line Pv) specific to the lactate dehydrogenase of P. vivax species and the other (test line Pf) with Monoclonal Anti-HRP-II which is specific to the Histidine Rich Protein-II of P. falciparum. AccuTest Malaria Pf(HRP II)/Pv is a rapid qualitative, chromatographic immunoassay for the detection of malaria infection in human blood sample indicating differential diagnosis between Plasmodium falciparum and Plasmodium vivax species. PRINCIPLE: AccuTest Malaria Pf (HRP II)/Pv test utilizes the principle of immuno-chromatography. It has the test strip coated with Monoclonal Anti-pLDH antibodies (test line Pv) specific to the lactate dehydrogenase of P.vivax species and the other (test line Pf) with Monoclonal Anti-HRP-II which is specific to the Histidine Rich Protein-II of P.falciparum. As the test sample flows through the membrane assembly of the device after addition of the buffer solution, the colored colloidal gold, anti-pLDH antibody and the anti-HRP-II antibody conjugate complexes with the lysed blood sample. The Malaria antigens get immobilized on the respective test lines on the nitrocellulose membrane which leads to the formation of red/purple colored band/s. The un-reacted conjugate and unbound complex if any moves further on the membrane and are subsequently immobilized at the control “C” region forming a red/purple band. This control band serves to validate the test performance and should always appear. This test is intended for professional use and must be used by trained personnel. Related products Safety Information PRECAUTIONS: 1. For in-vitro diagnostic use only. 2. The device is sensitive to humidity as well as to heat. So, it’s very important to take out the device from the sealed pouch just before use. 3. Do not use the kit after the expiration date. 4. Dispose all the samples and kits properly after test, in accordance with GLP. 5. Do not pipette reagent or blood by mouth. Direction for Use Procedure: 1. Disinfect with alcohol swab 2. Punture by lancet 3. Collect blood upto marking on sample dropper Other Info STORAGE AND EXPIRATION: 1. AccuTest Malaria Pf(HRP II)/Pv test kit should be stored between 4 – 30ºC. 2. Expiration date of this kit is 18 months after its manufacture date.

Buy AccuTest HIV – 1/2 Ab Rapid Card Test (50 Tests) Online from Accurex. This Rapid HIV test is a visual, solid phase immunochromatographic assay for qualitative in-vitro diagnostic detection of antibodies against HIV-1 and HIV-2 in human serum/plasma. This HIV test may be used as an aid in diagnosis of HIV infection. In the HIV blood test – A reactive result should be confirmed by supplemental testing as part of a validated HIV testing algorithm. INTENDED USE: AccuTest HIV – 1/2 Ab test is a visual, solid phase immunochromatographic assay for qualitative in-vitro diagnostic detection of antibodies against HIV-1 and HIV-2 in human serum/plasma. The product may be used as an aid in diagnosis of HIV infection. A reactive result should be confirmed by supplemental testing as part of a validated HIV testing algorithm. INTRODUCTION: The Human Immunodeficiency Virus (HIV) is a retrovirus that infects cells of the immune system, destroying or impairing their function. The most advanced stage of HIV infection is Acquired Immunodeficiency Syndrome (AIDS). The general method of detecting infection with HIV is to observe the presence of antibodies to the virus by an EIA method followed by confirmation with any confirmation method. AccuTest HIV – 1/2 Ab is a simple, visual qualitative test that detects antibodies in human serum/plasma. The test is based on immunochromatography and can give a result within 15 minutes. PRINCIPLE: AccuTest HIV – 1/2 Ab employs chromatographic lateral flow device in a cassette format. Colloidal gold conjugated recombinant antigens (Au-Ag) corresponding to HIV-1 (gp120 + gp41) and HIV-2 (gp-36) are dry-immobilized at the end of nitrocellulose membrane strip. HIV-1 & HIV-2 antigens are bound at the Test Zone (1 & 2) respectively. Goat Anti-Mouse IgG antibodies are bound at the Control Zone(C). When the sample is added, it migrates by capillary diffusion rehydrating the gold conjugate. If there are HIV-1 or HIV-2 antibodies in sample, they will bind with the gold conjugated antigens forming particles. These particles will continue to migrate along the strip until the Test Zone (1 or 2) where they are captured by the HIV-1 or HIV-2 antigens generating a visible purple line. If the specimen contains antibodies to HIV-1, the specimen will bind to the 1 test line and produce line. If specimen contains antibodies to HIV2, the specimen will bind to the 2 test line. If there are no HIV-1 or HIV-2 antibodies in sample, no purple line is formed in the Test Zone. The gold conjugate will continue to migrate alone until it is captured in the Control Zone (C) by the Goat Anti Mouse IgG antibodies aggregating in a purple line, which indicates that the migration of liquid has been successful. The control line must be present for the test to be valid. PRECAUTIONS: 1. For best results, adhere to instructions provided. 2. All specimens should be handled as potentially infectious. 3. The test device is sensitive to humidity as well as heat. 4. Do not use beyond expiration date. 5. Do not use test kit if pouch is damaged or seal is broken. 6. Use test device immediately after removing from the pouch. 7. The components (test device and assay diluents) in this kit have been quality control tested as a standard batch unit. Do not mix components from different lot numbers. 8. The AccuTest HIV – 1/2 Ab Test devices should be stored at 4 to 30 °C. Do not expose the kit to temperature over 30 °C. 9. Specimen with extremely high concentrations of red blood cells, fibrin should be recentrifuged before use. 10. AccuTest HIV – 1/2 Ab Test Device (Serum/Plasma) is for in vitro diagnostic use only. 11. AccuTest HIV – 1/2 Ab Test Device (Serum/Plasma) will only indicate the presence of antibodies to HIV-1/2 in the specimen and should not be used as the sole criteria for the diagnosis of HIV-1, HIV-2, and/or HIV-1 subtype O infection. 12. For confirmation of reactive test results, specimens should undergo further testing using different assays, such as rapid diagnostic tests, EIA and/or Western blotting in accordance with a validated HIV testing algorithm. 13. As with all diagnostic tests, all results must be interpreted together with other clinical information available to the physician. 14. Results should not be used to determine the serotype of HIV infections TEST PROCEDURE: 1. Allow the test device, buffer and specimen to reach room temperature (15-30 °C) prior to testing. 2. Remove the test device from the foil pouch and use the test device as soon as possible (within one hour). 3. Place the device on a flat, dry surface. Label with specimen ID. 4. Holding the sample dropper vertically above the test disk, slowly transfer 1 drop (10µl) of sample in to the sample well, then add 2 drops of assay diluent (about 75 µl) and start the timer. 5. As the test begins to work, you will see purple color moving across the result Window in the center of the Test Disk. 6. Wait for the colored lines to appear. Interpret test results at 15 to 20 minutes. Do not interpret test result after 20 minutes. STORAGE AND STABILITY Store as packaged in the sealed pouch at 4-30 °C (storage in refrigerator is permitted). Do not store in the freezer. Protect the test kit from humidly. The test device is stable until the expiration date printed on the test kit and/or sealed test device pouch. Do not use beyond the expiration date. The test device must remain in the sealed pouch until use.