Biocredit DUO COVID-19 rapid test for the detection of IgG+IgM antibodies, 50pcs

Action

A set of reagents for immunochromatographic detection of IgM/IgG antibodies to the SARS-CoV-2 virus in whole blood, serum or plasma samples (BIOCREDIT COVID-19 IgG+IgM Duo) is designed to perform fast and high-quality immunochromatographic analysis for detecting IgG and IgM antibodies specific to the SARS-CoV-2 coronavirus antigen in human biological material samples (serum, plasma or whole blood samples). The structure of the device includes a substrate with the addition of colloidal gold nanoparticles to form conjugated complexes made using the Black Gold Particle technology developed just a year ago by scientists from the Tata Institute of Fundamental Research (TIFR). Also included in the structure of the device is a membrane reagent strip (according to the T testing line), which is pre-coated with IgG and IgM antibodies specific to the SARS-CoV-2 coronavirus antigen. If there is a SARS-CoV-2 coronavirus antigen in the test biological sample, as a result of the formation of an antibody-antigen-antibody complex with the involvement of an indicator (colloidal gold nanoparticles), a visible black stripe appears along the testing line (marked with the letter T). The control line (marked with the letter C) is provided in the test cassette as a means for integrated verification of the correct execution of the test procedure. Staining of the control line (C) must occur under all conditions, regardless of the test results, if the test procedure is performed correctly

Indications

For the qualitative determination of the presence of IgM or IgG antibodies to the coronavirus(SARS-CoV-2) in samples of serum, plasma (with the addition of sodium citrate retiredmilitary acid or heparin) and whole blood, suitable vesnakov or blood from a finger, taken by a capillary method in patients with clinicalscientific respiratory diseases with suspected infection COVID-19, as well as in individuals with no signs of catarrhal diseases and do not yavlyayushchikhsya with patients with COVID-2019.

Recommendations for use

Collection and storage of biological samples 1. Taking a whole blood sample(1) Taking a whole blood sample from the finger a) Using a cotton swab soaked in alcohol, wipe the area of the finger from which the whole blood sample will be taken; b) Squeeze the tip of the finger and make a puncture using a sterile scarifier (lancet); c) Using a sterile cotton swab or gauze, remove the first drop of blood;d) Use a micro-pipette (not included in the Kit) to take the sample. While maintaining compression, immerse the micro-pipette in a drop of blood on the surface of the finger, then carefully stop compressing to ensure that the blood leaves the puncture freely (volume 20 µl). (2) Taking a whole blood sample from a venusfor taking a whole blood sample from a vein, use the standard procedure. Collect blood in a test tube that contains a suitable anticoagulant (for example, sodium salt of ethylenediaminetetraacetic acid, sodium heparin or sodium citrate).2. Plasma Sampling To take a whole blood sample from a vein, use the standard procedure. Collect blood in a test tube that contains a suitable anticoagulant (for example, sodium salt of ethylenediaminetetraacetic acid, sodium heparin or sodium citrate). The resulting whole blood sample is then centrifuged to separate the plasma. 3. Taking a serum sample To take a whole blood sample from a vein, use the standard procedure. Collect blood in a test tube that DOES NOT CONTAIN an anticoagulant (for example, sodium salt of ethylenediaminetetraacetic acid, sodium heparin or sodium citrate). Allow the whole blood sample to stand for 30 minutes for clotting, then centrifuge to separate the supernatant layer. Sample storage procedures Perform testing immediately after taking the sample. It is forbidden to leave biological samples for a long time at room temperature (1 ~ 40 °C). If it is not possible to perform an immediate analysis, it is allowed to store whole blood samples for a maximum of 24 hours in the refrigerator, at a temperature in the range of 2-8 °C. Serum and plasma samples can be stored for 72 hours in the refrigerator, at a temperature in the range of 2-8 °C, or for a longer time in the freezer at a temperature not exceeding -20 °C.

Contraindications

1. Expired shelf life of the test 2. Product packaging is broken 3. Improper storage and transportation conditions. 4. There are no other contraindications, except for cases when the material can be collected for medical reasons.

How to take, course of use and dosage

Test Procedure 1. Before performing the test, stabilize the temperature of the biological sample and all components of the Kit at room temperature. 2. Open the individual packaging envelope and remove the test cassette. Place the cassette on a dry, flat surface. Testing procedure for COVID-19 IgG class antibodies: 1. Using a disposable capillary pipette (included with the Kit), transfer 10 µl of a serum or plasma sample or 20 µl of a whole blood sample (using a micropipette) to the center of the sample recess on the surface of the test cassette marked with the letter S. 2. Add 3 drops of sample diluent to the center of the buffer solution recess on the surface of the test cassette marked B ( * ). Make sure that an adequate volume of diluent and a sufficient volume of biological sample are used for the test. Insufficient or excessive sample volume, as well as insufficient or excessive diluent volume, may result in inaccurate (unreliable or distorted) test results. 3. Read the test result in 5-10 minutes Attention: do not interpret the result obtained 10 minutes after testing. Testing procedure for COVID-19 IgM antibodies: 1. Using a disposable capillary pipette (included with the Kit), transfer 10 µl of a serum or plasma sample or 20 µl of a whole blood sample (using a micropipette) to the center of the sample recess on the surface of the test cassette marked with the letter S. 2. Add 3 drops of sample diluent to the center of the buffer solution recess on the surface of the test cassette marked B ( * ). Make sure that an adequate volume of diluent and a sufficient volume of biological sample are used for the test. Insufficient or excessive sample volume, as well as insufficient or excessive diluent volume, may result in inaccurate (unreliable or distorted) test results. 3. Read the test result in 5-10 minutes Attention: do not interpret the result obtained 10 minutes after testing. Interpretation of resultsnegative test resultsif only the control line (C) is colored red in the result display window: the analysis gave a negative result for the presence of antibodies to coronavirus. Positive test resultif the control line (C) is colored red in the result display window and the IgG class antibody test line (T) is colored black: the test showed a positive result for the presence of IgG class antibodies to coronavirus;If the control line (C) is colored red in the result display window and the IgM class antibody test line (T) is colored black: the test showed a positive result for the presence of IgM class antibodies to coronavirus. Invalid test Resultif there is no red-colored control line (C) in the result display window, the test result is invalid. The reason for this result may be a violation of the requirements of the procedures for taking a biological sample, and/or procedures for conducting analysis, or the unusability of the test cassette (test system) used. In these circumstances, it is recommended to perform a second analysis using a new test cassette. Note: the width of the strip or the intensity of staining does not matter.

Description

Designed for high-quality detection of IgM and IgG antibodies to the COVID-19 coronavirus in whole blood samples (venous and capillary), serum or plasma. The kit is an auxiliary tool for the diagnosis of SARS-CoV-2. When testing biological samples using a Kit, the results obtained indicating the reactivity of the sample should be confirmed using alternative methods of analysis. The kit is intended only for performing laboratory diagnostics in vitro. The medical device is intended for use only by professional healthcare professionals.

Description

The new variety identified in 2019 (2019-nCoV-2) is a single-stranded RNA coronavirus. The respiratory disease caused by the new virus is called coronavirus infection COVID-19. The 2019-nCoV virus belongs to the beta-coronavirus genus. This family includes the coronavirus that causes the development of severe acute respiratory syndrome (SARSCoV,2003) and the development of Middle East respiratory syndrome (MERS-CoV,2012). The structure of coronaviruses includes four types of viral proteins, called spike protein (S), envelope protein (E), membrane protein (M), and nucleocapsid protein (N). The group of most common symptoms of coronavirus infection includes symptoms from the respiratory system, high fever (fever, fever), cough, shortness of breath and various degrees of difficulty breathing.With a more severe course of the disease, the infection can cause the development of pneumonia, severe acute respiratory syndrome, kidney failure, and even lead to death. The standard set of recommendations for preventing the spread of infection includes regular and thorough hand washing, covering the mouth and nose when coughing and sneezing, and careful heat treatment of food products, including meat and eggs. It is also recommended to avoid close contact with people who show signs and symptoms of a painful condition, such as coughing and sneezing. The target analyte is IgM or IgG antibodies to coronavirus (SARS-CoV-2). In the course of the study, a qualitative characteristic is established – the presence or absence of antibodies. Class M immunoglobulins (IgM) as well as Class G immunoglobulins (IgG) are immunoglobulins that are produced by the immune system. Usually, IgM levels start to rise 1 week after the initial infection, whereas IgG appears later than IgM (usually about 14 days after infection)

Functional Features

1. Sensitivity and specificity Tests of a set of reagents for immunochromatographic detection of IgM/IgG antibodies to the SARS-CoV-2 virus in whole blood, serum or plasma samples (BIOCREDIT COVID-19 IgG+IgM Duo) were performed using a sample of biological samples previously tested using equipment that uses the real-time polymerase chain reaction (PCR) method. For each test sample, data were recorded on the time of sample collection relative to the time of onset of symptoms of the disease. The results obtained are presented in Table 1. Table 1. Analytical sensitivity data Analytical sensitivity

Tests of a set of reagents for immunochromatographic detection of IgM/IgG antibodies to SARS-CoV-2 virus in whole blood, serum or plasma samples (BIOCREDIT COVID-19 IgG+IgM Duo) were performed using a sample of biological samples previously tested using equipment that uses the method of solid-phase enzyme immunoassay (ELISA). The results obtained are presented in Table 2/Table 2.

During clinical and laboratory tests in the Russian Federation, the following diagnostic characteristics were obtained: diagnostic sensitivity of Ig G 89.29% (95% confidence interval (CI) 71.77-97.73%), Ig M 78.12% (95% confidence interval, CI 60.03-90.72%) and diagnostic specificity of Ig G 98.04% (95% confidence interval, CI 89.55-99.95%), Ig M 96.15% (95% confidence interval, CI 86.79-99.53%).2. Reproducibility To check the accuracy and reproducibility indicators within the same series and for different experimental series, samples from three different product series were used to test the following sample set: samples with a negative determination result, samples with a weak, moderate and strongly pronounced positive determination result. All tests were performed in three replicates. In all replicates of all experimental series, the result of identifying the results was 100%.3. Cross-reactivity To test the potential of cross-reactivity, A reagent kit for immunochromatographic detection of IgM/IgG antibodies to SARS-CoV-2 virus in whole blood, serum or plasma samples (BIOCREDIT COVID-19 IgG+IgM Duo) it was tested against samples containing the following antibodies: antibodies to the causative agent of syphilis, IgG class antibodies to the hepatitis A virus, antibodies to the hepatitis B virus, IgG class antibodies to the human immunodeficiency virus, IgM class antibodies to the human immunodeficiency virus, and antibodies to the hepatitis C virus. For all the antibodies tested, the SARS-CoV-2 Immunochromatographic Antibody Detection Kit in whole blood, serum, or plasma samples (BIOCREDIT COVID-19 IgG+IgM Duo) showed no potential for cross-reactivity. 4. Interferenceto check interference, a set of reagents for immunochromatographic detection of IgM/IgG antibodies to SARS-CoV-2 virus in whole blood, serum or plasma samples (BIOCREDIT COVID-19 IgG+IgM Duo) was tested against samples containing 14 endogenous and exogenous substances with established interaction potential. The obtained test results showed that the Set of reagents for immunochromatographic detection of IgM/IgG antibodies to SARSCoV-2 virus in whole blood, serum or plasma samples (BIOCREDIT COVID-19 IgG+IgM Duo) did not interact with the analyzed substances of endogenous and exogenous nature. 5. Stability The results of stability studies of a Set of reagents for immunochromatographic detection of IgM/IgG antibodies to SARS-CoV-2 virus in whole blood, serum or plasma samples (BIOCREDIT COVID-19 IgG+IgM Duo) by the method of “accelerated aging” at a temperature of 50 °C showed that the Kits are stable for 129%%3. Disposable capillary pipettes – 50 pcs. 4. Instructions for use – 1 pcMaterials not included in the delivery package:- Protective gloves;- Safety glasses;- Alcohol-soaked napkin; – Micropipette; – Scarifier (lancet);- Blood collection tubes.

Functional advantages

The kit is used as an auxiliary tool in diagnostics.The results of antibody testing should not be used as the sole basis for confirming or excluding SARS-CoV-2 infection or for informing about the status of infection.

Special instructions

1. The kit is intended for in vitro laboratory diagnostics only. 2. Exposure to moisture or heat radiation can reduce the stability of reagents. Given this circumstance, the medical device should be used as soon as possible after opening the foil packaging envelope, without exposing the test system to the external environment for a long time. 3. Do not use the Kit if there is damage to the packaging elements (the envelope for packaging the individual test cassette or the aluminum foil membrane for sealing the diluent bottle).4. After testing is completed, all samples and materials must be properly disposed of. When handling and disposing of any biological materials that may potentially be infectious, all requirements set out in biosafety standards, guidelines, and procedures must be strictly observed. For disposal, it is necessary to use special containers for biological waste. 5. Use protective gloves, protective outer clothing and safety glasses when handling test samples. Wash your hands thoroughly after testing. 6. Performing repeated cycles of freezing and thawing biological samples may result in false positive or false negative results. 7. Before disposal of solid waste, it is necessary to decontaminate it by autoclaving it for 1 hour at a temperature of 121 °C. 8. The solution for diluting the biological sample contains sodium azide in an amount of less than 0.1%. If the diluent comes into contact with the skin or eyes, the affected person should wash the affected areas of the skin or eyes with plenty of running water and seek qualified medical attention, if necessary. 9. Do not use the medical device after the expiration date. 10. The medical device is not intended for repeated use. 11. When testing, it is forbidden to use components of the Kit from different series. 12. It is forbidden to use for testing biological samples that have been subjected to hemolysis procedures, or samples with signs of contamination by microorganisms, because when analyzing such samples, erroneous test results may be obtained. 13. If you receive controversial (doubtful) results, it is recommended to perform an analysis using alternative methods available in these clinical conditions. Just as in the case of any other testing methods and systems, the results of this type of testing should not be used as the sole basis for making a diagnosis. The final decision should be made by the doctor (clinical specialist) after reviewing the results of all laboratory tests and analyzes, taking into account the assessment of the overall clinical picture.

Storage conditions

* Store the kit in its original packaging at a temperature of 1-40 °C. * The test cassette should be stored in an unopened packaging envelope until the analysis is completed immediately. * Do not freeze.

Shelf

life is 24 months from the date of manufacture. Do not use after the expiration date of the