Intended use: Toxoplasma IGG/IGM rapid test is a rapid immunochromatographic test for the simultaneous detection of IGM and IGG antibodies to toxoplasma gondii in human serum/plasma. The test can be used as a screening test for toxoplasma infection and as an aid for differential diagnosis of the self limiting primary toxoplasma infections and the potentially fatal secondary toxoplasma infections in conjunction with other criteria. Test principle: The toxoplasma IGG/IGM rapid test is a lateral flow chromatographic immunoassay. The test cassette consists of: 1) A burgundy colored conjugate pad containing toxoplasma recombinant envelope antigens conjugated with colloid gold (toxoplasma conjugates) and rabbit igg-gold conjugates, 2) A nitrocellulose membrane strip containing two test bands (t1 and t2 bands) and a control band (c band). The t1 band is pre-coated with the antibody for the detection of IGM anti-toxoplasma, t2 band is coated with antibody for the detection of igg anti-toxoplasma, and the c band is pre-coated with goat anti rabbit IGG. Absence of any t bands (t1 and t2) suggests a negative result. The test contains an internal control (c band) which should exhibit a burgundy colored band of the immunocomplex of goat anti rabbit igg/rabbit igg-gold conjugate regardless of the color development on any of the t bands. Otherwise, the test result is invalid and the specimen must be retested with another device. Reagents and materials supplied : 1. Test cassette individually foil pouched with a desiccant. 2. Plastic dropper 3. Buffer 4. Package insert. Storage and stability: The kit must be stored at 2-30pc. Warning and precautions: 1. For in vitro diagnostic use only. Not for medicinal use. 2. Do not use beyond expiry date. 3. Read the instructions careful y before performing the test. 4. Handle all specimen as potential y infectious. 5. Follow standard biosafety guidelines for handling and disposal of potential y infective material.
General Information One-Step Chagas IgG/IgM Rapid Test is detection of IgG anti-Trypanosoma cruzi (T. cruzi) in human blood. Sensitivity: 92.9% , Specificity: 100% Specimen : Serum, Plasma or Whole Blood Reading Time : 10 min
The COVID-19 IgG/IgM (Whole Blood/Serum/Plasma) Rapid Test Device utilizes lateral flow technology that is used for the qualitative, differential detection of both anti-SARS-CoV-2 IgM and IgG antibodies. In general, antibodies can be detected 1-3 weeks after infection. This test is intended to screen patients for COVID-19. Combining RNA and Antibody tests can significantly raise the sensitivity for detecting COVID-19 in infected individuals. This test has been authorized by the FDA under a EUA for professional use CLIA and CLIA WAIVED for Point Of Care. This test has been authorized only for the presence of IgM and IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens. This product is intended for professional use and not for home use. FACT SHEET FOR HEALTHCARE PROVIDERS This test has been authorized by the FDA under a EUA for use by authorized CLIA laboratories. This device is CLIA waived for point of care use for fingerstick whole blood specimens only. The user should be trained in the procedure. Wear appropriate protective attire for your safety when handling patient samples. This test has been authorized only for the presence of IgM and IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens. There should be a blue line in the control region (next to ) before testing, discard the device if there is no blue line.
SARS-CoV-2 IgG/IgM Cartridge Kit include : 1 Test Box + 1 Cartridge + 1 UV Touch SARS-CoV-2 IgG/IgM Kit is used for rapid and accurate screening of the COVID-19, which helps identify suspected patients and reduce false negative rate. Rapid detection of recent SARS-CoV-2 infection In ONLY 12 minutes ONE-STEP operation Single cartridge, NO additional buffers TRFIA Europium particles displays Clear and Bright results Dual capturing antigens (S and N) enhanced sensitivity Important complement to PCR detection in COVID-19 diagnosis
Rapid Influenza A + B Test Card Intended Use Influenza A+B Test is an in vitro immunochromatographic assay for the qualitative detection of influenza type A and type B nucleoprotein antigens in nasopharyngeal swab, nasal swab and nasal aspirate samples. The identification is based on the monoclonal antibodies specific for the nucleoprotein of Influenza virus A. It is intended to aid in the rapid diagnosis of influenza infection. Negative results should be confirmed by other methods, such as cell culture. Contents of Kit Flu A + B Test Card 20 ea Sample Extraction Buffer 1 ea Extraction Tube 20 ea Nozzle With Filter 21 ea Sterilized Swab 20 ea Tube Stand 1 ea Instructions For Use 1 ea Storage And Stability Store the Influenza A+B Rapid Test at room temperature or refrigerated (2-30ípC). Do not freeze. All reagents are stable until the expiration dates marked on their outer packaging and buffer vial. Pre Cautions 1. For in vitro diagnostic use only. 2. Do not use after the expiration date. 3. The test device should remain in the sealed pouch until use. 4. If the Influenza A+B Rapid Test kit was kept refrigerated, let all the reagents warm up to room temperature (15ípC -30ípC) before proceeding with the test. 5. Wear gloves when handing the samples, avoid touching the reagent membrane with your fingers. 6. Discard gloves, swabs, test tubes, and test devices in accordance with the local regulation. 7. Visibly bloody samples should not be used for the testing. 25 tests/kit, 40 kits/carton
Product Name: Coronavirus (COVID-19) Antigen Rapid Test Cassette (Swab), COVID-19 Antigen Test Kit, SARS COV 2 Variant Test Kits Sample type Throat OR nasal swab Detection type Qualitative Method: Colloidal Gold Rapid Test Function: Diagnose Certificate: ISO9001/ ISO13485/CE Format: Strip, Cassette, Midstream Sensitivity: 96.23% Specificity: 99.11% Accuracy: 98.56% Reading time: 15 minutes Packaging Details: Pouch+Box+Carton packaging (1) With our company's Logo (2) With the natural package (3) With OEM package (4) ODM
Product Name: Coronavirus (COVID-19) Antigen Rapid Test Cassette (Swab), COVID-19 Antigen Test Kit, SARS COV 2 Variant Test Kits Sample type Throat OR nasal swab Detection type Qualitative Method: Colloidal Gold Rapid Test Function: Diagnose Certificate: ISO9001/ ISO13485/CE Format: Cassette Sensitivity: 96.23% Specificity: 99.11% Accuracy: 98.56% Reading time: 15 minutes Packaging Details: Pouch+Box+Carton packaging (1) With our company's Logo (2) With the natural package (3) With OEM package (4) ODM
Uncut Sheet HIV 1/2 Tri-Lines Rapid Test Package:30sheets/pouch Specimen:Whole blood/Serum/plasma INTENDED USE The HIV-1/2 Rapid Screen Test (RST) is a qualitative test for the detection of antibodies to Human Immunodeficiency Virus type 1 and 2(HIV-1/2) in human serum/plasma and whole blood. It is considered as an initial screening test for HIV-1/2 antibodies. All positive specimens must be confirmed with Western Blot or other qualified EIA. PRECAUTION 1.For in vitro diagnostic uses only. 2.All patient samples should be treated as if capable of transmitting diseases. 3.Do not use test kit beyond expiration date. 4.Icteric, lipemic, hemolysed, heat treated and contaminated sera may cause erroneous results. SUMMARY AND EXPLANATION OF THE TEST It has been shown that the acquired immunodeficiency syndrome (AIDS) is caused by viruses transmitted by sexual contact, transfusion, use of contaminated blood products and sharing contaminated needles. HIV-1 and HIV-2 viruses have been isolated from patients with AIDS and AIDS-related complex (ARC), high-risk persons for AIDS. HIV-1 and HIV-2 viruses delete T helper cells, a subpopulation of T cells for body defense, thus causing AIDS patients susceptible to opportunistic infections and developing malignant tumors. The incidence of specific antibodies to HIV-1/2 is high in AIDS, ARC and persons with high risk for AIDS. The HIV-1/2 Rapid Screen Test is designed to detect antibodies to HIV-1/2 in AIDS patients, ARC or high risk persons and identify any potential donors carrying these antibodies in serum specimens. PRINCIPLE HIV-1/2 RST is a chromatographic immunoassay (CIA) for the detection of antibodies to HIV-1/2 in human serum/plasma and whole blood. HIV-1/2 specific antigens are precoated onto membrane as a capture reagent on the test region. During the test, specimen is allowed to react with the colloidal gold particles, which have been labeled with HIV-1/2 specific antigens. Antibodies to HIV-1/2, if present, a red colored band will develop on the membrane in proportion to the amount of HIV-1/2 antibodies present in the specimen. Absence of this red colored band in the test region suggests a negative result. To serve as a procedural control, red colored band in the control region will always appear regardless the presence of antibodies to HIV-1/2.
Uncut Sheet Influenza A/B Rapid Test Specimen:nasal swab Intended Use The Influenza A +B Test is a rapid chromatographic immunoassay for the qualitative detection of influenza type A and B nucleoprotein antigens in nasopharyngeal swab and nasal aspirate specimens. This kit is intended to be used as an aid in the diagnosis of influenza A and influenza B virus in nasal swab specimens. Principle The Influenza A +B Test is a qualitative membrane strip based immunoassay for the detection of influenza type A and B nucleoprotein antigens in nasopharyngeal swab and nasal aspirate specimens. In this test procedure, influenza type A antibody is immobilized in the A line, influenza type B antibody is immobilized in the B line. After a specimen is placed in the specimen well, it reacts with influenza type A antibody and/or B antibody coated particles that have been applied to the specimen pad. This mixture migrates chromatographically along the length of the test strip and interacts with the immobilized antibody. If the specimen contains influenza type A, a colored line will appear in the A line region indicating a influenza type A positive result. If the specimen contains influenza type B, a colored line will appear in the B line region indicating a influenza type B positive result. Absence of any T lines (A and B) suggests a negative result. To serve as a procedural control, a colored line will always appear at the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred. Storage and Stability 1.Store as packaged in the sealed pouch at room temperature or refrigerated (4-30 or 40-86). The test device is stable through the expiration date printed on the sealed pouch. 2.The test must remain in the sealed pouch until use.
MOR Test SUMMARY AND EXPLANATION OF THE TEST The MOR Gold Rapid Screen Test Strip is a fast and easy to read membrane chromatographic immunoassay with no need for instrument. The method employs a unique combination of monoclonal and polyclonal antibodies to specifically identify Morphine in urine with a high degree of sensitivity. Morphine, one of opiates�¢?? derivatives, is central nervous system stimulants that produce alertness, wakefulness, increased energy, reduced hunger, and an overall feeling of well-being. Morphine has been the preferred drug for the management of pain in cases of advanced cancer and other severe conditions. Morphine and other Opiates�¢?? metabolites may be detected in urine as a result of heroin morphine, codeine, or poppy seed intake. Administration of large doses of Morphine can cause tolerance and physiological dependence in users, and can lead to substance abuse. D-Morphine is controlled substances. GC/MS or immunoassay method has been developed for the determination of 300ng/ml for Morphine. MOR Test PRINCIPLE During a test labeled antibody-dye conjugate mixes with urine specimen and binds to the free drug if it is presented in the sample, to form an antibody-antigen complex. This complex prevents the formation of pink color bands in the test zone of the dip-stick if drug to be detected in specimen is above the detection levels (300ng/ml for Morphine). In case of absent of drug and its metabolites, unbound dye conjugate will bind to the antigens immobilized in the test zone to form a pink reaction line. To serve as a quality control for the assay, another pink line will always appears in the test zone regardless positive or negative result. Packaging Details: Pouch+Box+Carton packaging (1) With our company's Logo (2) With the natural package (3) With OEM package (4) ODM
After the virus infection, the antibody IgM appears and rises in the early stage, while antibody IgG appears and rises in the late stage. â?¢ By combining IgG and IgM, we can know if the body is infected and at which stage . the Kit inckude: Novel Coronavirus (2019-nCoV) IgG/IgM Test Kit (Colloidal Gold) â?¢ Transport or store at room temperature from 2 to 30°C â?¢ If individual pouch unopened, the kit can be stored for 12 months. â?¢ Once the individual pouch is opened, this test card should be used within 1 hour.
Uncut Sheet Leishmania IgG/IgM Rapid Test Specimen:Whole Blood/ Serum/ Plasma INTENDED USE The Leishmania IgG/IgM Rapid Test is a lateral flow immunoassay for the qualitative detection of antibodies including IgG and IgM to the subspecies of the Leishmania donovani (L. donovani), the Visceral leishmaniasis causative protozoans in human serum or plasma. This test is intended to be used as a screening test and as an aid in the diagnosis of the disease of Visceral leishmaniasis. Any reactive specimen with the Leishmania IgG/IgM Rapid Test must be confirmed with alternative testing method(s). SUMMARY AND EXPLANATION OF THE TEST Visceral leishmaniasis, or Kala-azar, is a disseminated infection caused by several subspecies of the L. donovani. The disease is estimated by the World Health Organization (WHO) to affect approximately 12 million people in 88 countries1. It is transmitted to humans by bites of the Phlebotomus sandflies, which acquire infection from feeding on infected animals. Though it is a disease for poor countries, in Southern Europe, it has become the leading opportunistic infection in AIDS patients2-3. Identification of L. donovani organism from the blood, bone marrow, liver, lymph nodes or the spleen provides a definite means of diagnosis. However, these test methods are limited by the sampling method and the special instrument requirement. Serological detection of anti-L. donovani Ab is found to be an excellent marker for the infection of Visceral leishmaniasis. Tests used in clinic include: ELISA, fluorescent antibody and direct agglutination tests4-5. Recently, utilization of L. donovani specific protein in the test has improved the sensitivity and specificity dramatically6-7. The Leishmania IgG/IgM Rapid Test is a recombinant protein based serological test, which detects antibodies including IgG, IgM and IgA to the L. Donovani. This test provides a reliable result within 10 minutes without any instrumentation requirements.
INTENDED USE The test kit utilize purified Chlamydia Trachomatis Antibody antigen, based on GIFA principle and use indirect method to detect Urea Plasma Urealyticum antibody in human serum. TEST PROCEDURE 1. Remove the test kit and put it at room temperature (for about 20-30mins) before testing. 2. Add 1 drop of Wash Buffer into the hole and allow the liquid soak the membrane completely. 3. Add 150�l of the serum specimen into the hole and allow it to sufficient absorption. 4. Add 3 drops of Colloidal Conjugate into the hole and allow it to sufficient absorption. 5. Add 3 drops of Wash Buffer into the hole and allow it to sufficient absorption. Read the results within 3 minutes. STORAGE The kit can be stored at room temperature (2-30°C). The test kit is stable through the expiration date (18 months) marked on the foil pouch. DO NOT FREEZE. Do not store the test kit in direct sunlight.
We are a manufacturer of SARSCoV2 RAPID TEST CASSETTE in China. We can provide customers following SARSCoV2 rapid testing products that have obtained the CE or other certifications. And has been exported to Thailand, the Philippines, Germany, Italy, Ecuador, South Africa and other countries. SARSCoV2 IgG/IgM Rapid Test Cassette; SARSCoV2 Antigen Rapid Test (nasopharyngeal swab); SARSCoV2 Antigen Rapid Test (Saliva); SARSCoV2 and Influenza A+B Antigen Combo Rapid Test; SARSCoV2 Neutralizing Antibody Test Kit;
Test type : Antibody (one drop of finger stick blood, 15 minutes detection time) Packing : Individually packed 10 test kits per box Available Certificates : FDA registered, CE, ISO 13485:2016 MOQ : 8000 pcs / 1 Pallet
WONDFO SARS-CoV-2 Antibody test kits (Later Flow Method), Rapid response 15 minutes - Easy to use, no equipment required - Multiple sample types, including fingerstick blood - Instant result in 15 minutes - CE marked in vitro diagnostics for professional use in the EU - Measuring IgG/IgM - Specificity 99.57% In Stock Now ready to ship or for inspection 10,000 Test Kits Stockholm 50,000 Test kits in Hong Kong 50,000 Test kits in Jakarta
INTENDEDUSE:2019-nCoV IgG/IgM Antibody Test is an immunochromatographic assay for the rapid, qualitative and differential detection of IgG and IgM antibodies to 2019 Novel Coronavirus in human whole blood, serumorplasma sample.Thetestistobeusedasanaidinthediagnosisofcoronavirusinfectiondisease (2019-nCov),whichiscausedbySARS-CoV-2. This test provides only a preliminary test result. Any reactive specimen with the 2019-nCoV IgG/IgM test must be confirmed with alternative testing method(s) and clinical findings. INTRODUCTION: Coronaviruses are enveloped RNAviruses that are distributed broadly among humans, other mammals, and birds and that cause respiratory, enteric, hepatic, and neurologic diseases. Seven coronavirus species are known to cause human disease. Four viruses - 229E, OC43, NL63, and HKU1 - are prevalent and typically cause common cold symptoms in immunocompetent individuals.4 The three other strains - severe acute respiratory syndrome coronavirus (SARS-CoV), Middle East respiratory syndrome coronavirus (MERS-CoV) and 2019 Novel Coronavirus (2019-nCoV) - are zoonotic in origin and have been linked to sometimes fatal illness. IgG and IgM antibodies to 2019 Novel Coronavirus can be detected with 2-3 weeks after exposure. IgG remains positive, but the antibody level dropsovertime.
The outbreak of the novel coronavirus (COVID-19) rapidly transmit all over China and lots of countries. Although molecular test (RT-PCR) has become the standard method for diagnosis of this disease, the method has many limitations. In addition, the high false negative rates were reported. There is an urgent need for an accurate and rapid testing method that quickly identify large number of infected patients and asymptomatic carriers to prevent virus transmission and assure timely treatment of patients. GenBody COVID-19 IgM/IgG device is a chromatographic immunoassay kit for the rapid and differential detection of immunoglobulin M (lgM) and immunoglobulin G (IgG) against COVID-19 using serum, plasma and whole blood.
CLIA Waived Use of this test with all authorized specimen types is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, that meet requirements to perform moderate or high complexity tests. This test is also authorized for use with fingerstick whole blood specimens only at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. The COVID-19 IgG/IgM Rapid Test Device is an in vitro immunoassay for the direct and qualitative detection of anti-SARS-CoV-2 IgM and anti-SARS-CoV-2 IgG in human whole blood, serum, or plasma. The test is for professional use only. Indication: Qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human venous whole blood (sodium EDTA), serum, or plasma (sodium EDTA). Intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. About Test Device EUA Authorized Gives Positive or Negative Result for COVID-19 virus Read Results in 15 Minutes 24 Month Expiration from Date of Manufacture Contents 20 Test Devices 20 Disposable Pipettes 20 Alcohol Prep Pads Sterile Safety Lancets Buffer Package Insert
The GENEDIA W COVID-19 Ag is an in vitro diagnostic single-use test and qualitative immunoassay to detect SARS-CoV-2 antigen in nasopharyngeal swab and sputum specimen from human. This assay is designed for professional personnel in laboratory and at point-of-care as an aid in screening patients suspected of being infected and asymptomatic patients. Allow wider testing with fast test time (10 minutes) Clinically proven data of asymptomatic patients available Separately packed extraction solution to minimize the possibility of contamination No additional instruments required Package Unit : 20 Tests/Kit Expiration Date : 24 Months (while sealed in the original aluminum foil pouch) GCMS manufactures COVID-19 antigen test kit, the GENEDIA W COVID-19 Ag which is listed on the EU common list, also with GMP and ISO certifications. GENEDIA W COVID-19 Ag is unaffected based on the in-silicon analysis of the mutations in the nucleocapsid (N gene) of Omicron viruses. Letter of statement is available upon your request. To get over COVID-19 pandemic, especially the recent Omicron breakout, currently we are doing big promotions for three kinds of COVID-19 Ag kit. All are in stock and available right away. 1. Nasopharyngeal 2. Nasal 3. Saliva The price is negotiable according to the amount of your order and shipping term. No MOQ is required but we prefer 1 pallet with 9,600 tests. (20 tests/kit, 30 kits/carton, 16 cartons/pallet)
