Biocredit COVID-19 Ag rapid coronavirus test, 20pcs

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A set of reagents for immunochromatographic detection of the SARS-CoV-2 antigen (BIOCREDIT COVID-19 Ag) is designed to perform fast and high-quality immunochromatographic analysis. The device is based on the principle of using a two-color system. The structure of the device includes a substrate with the addition of colloidal gold nanoparticles to form conjugated complexes, and a membrane strip of reagents (according to the T test line), on which antibodies specific to the SARS-CoV-2 coronavirus antigen are pre-applied.

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 system 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

To qualitatively determine the presence of SARS-CoV-2 antigen in a nasopharyngeal smear in individuals with clinical symptoms of respiratory disease with suspected COVID-19 infection.

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 cannot be collected for medical reasons.

Side effects

Not applicable for this MI.

How to take, course of use and dosage

Taking samples

1. Biological samples should only be taken by trained medical personnel. The handling of biological samples taken should be carried out carefully, taking into account the existing risk of infection.

2. When handling biological samples, care must be taken; any violation of the prescribed procedures may adversely affect the sample, and lead to unreliable test results.

3. To get more accurate test results, it is recommended to perform a smear on several areas of the nasopharyngeal region when taking a biological sample.

4. Perform testing immediately after taking the sample. If this is not possible, it is allowed to store the swab with the smear for a maximum of 12 hours in the refrigerator, at a temperature in the range of 2-8 °C, or for a maximum of 24 hours in the freezer at -20 °C.

Nasopharyngeal smear procedure To take a biological sample from the nasopharyngeal region, carefully insert a swab on a stick into the nasal cavity. Continue to gently insert the swab until there is no resistance in the nasal cavity. With gentle finger movements, turn the swab stick around several times and remove it from the nasal cavity. Visually make sure that the tip of the tampon is moistened.

Testing procedure

Preparatory stage

1. Before performing the test, stabilize the temperature of the biological sample and all components of the Kit at room temperature.

2. Do not open the individual packaging of the test cassette until all preliminary manipulations have been completed and the test procedure is ready for immediate use.

Testing steps

1. Remove the aluminum foil membrane from the vial containing the dilution buffer for biological samples. Place the swab with the nasopharyngeal swab in the buffer container, and press the tip of the swab against the inner wall or bottom of the vial to release the biological sample and transfer it to the buffer medium. While continuing to press the tip of the tampon against the wall or bottom, perform 5-10 circular movements.

2. Press the tip of the swab against the inner wall to squeeze the liquid out of it, then remove the swab from the bottle and dispose of it in accordance with the requirements that are established for the disposal of hazardous biological waste.

3. Securely close the bottle using the dropper attachment from the Kit.

4. Open the individual packaging envelope and remove the test cassette. Place the cassette on a dry, flat surface.

5. Turn the bottle with the buffer and biological sample upside down, and press lightly on its sides to release 3 to 4 drops (90 to 150 µl). The selected volume should be placed in the center of the sample recess on the surface of the test cassette, marked with the letter S. ( * ) Make sure that an adequate volume of the buffer containing the biological sample is used for testing. An insufficient or excessive sample volume, as well as an insufficient or excessive buffer volume, can lead to inaccurate (unreliable or distorted) test results.

6. Read the test result in 5 to 8 minutes. Attention: do not interpret the result obtained 8 minutes after testing.

Description

It is intended for qualitative detection of the SARS-CoV-2 antigen in human biological material (nasopharyngeal smear).

The kit is an auxiliary tool for early diagnosis of SARS-CoV-2 in patients with clinical symptoms of SARS-CoV-2 infection. 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.

Description

A set of reagents for immunochromatographic detection of SARS-CoV-2 antigen (BIOCREDIT COVID-19 Ag). Lot №H073009SD.

The kit is intended for use by personnel of clinical and diagnostic laboratories at least 18 years of age with higher and secondary medical, biological education, who have received appropriate professional training in the field of methods used and methods of safe work with pathogenic biological agents of pathogenicity groups I-IV.

The kit is intended for one-time use.

The kit is used as an auxiliary tool in early diagnosis. The results of antigen 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.

Functional features

Tests of a set of reagents for immunochromatographic detection of the SARS CoV-2 antigen (BIOCREDIT COVID-19 Ag) were performed using a sample of biological samples previously tested by real-time polymerase chain reaction (PCR). The results obtained are presented in the following table.

1. Sensitivity and specificity.

2. Precision

To check the accuracy (precision) within the same series and for different 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 identification result was 100%.

3. Cross-reactivity

To test cross-reactivity, a set of reagents for immunochromatographic detection of the SARS-CoV-2 antigen (BIOCREDIT COVID-19 Ag) was tested against samples containing 20 different microorganisms and viruses. The results obtained showed that this Set does not have cross-reactivity for all pathogens analyzed, with the exception of weak cross-reactivity, which was determined for the SARS CoV coronavirus.

4. Interference

To test interference, a set of reagents for immunochromatographic detection of the SARS-CoV-2 antigen (BIOCREDIT COVID-19 Ag) was tested against samples containing 14 endogenous and exogenous substances with an established interaction potential. The obtained test results showed no interference with the analyzed substances of endogenous and exogenous nature.

Result

Interpretation of results

Negative test result

If only the control line (C) is colored red in the result display window: the analysis gave a negative result for the presence of a coronavirus antigen.

Positive test result

If the control line (C) is colored red in the result display window and the test line (T) is colored black: the analysis gave a positive result for the presence of a coronavirus antigen.

Invalid test result

If 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.

Usage Restrictions

1. Testing can give a negative result if the content (titer) of coronavirus in a biological sample is at a level below the detection limit.

2. Getting a negative test result does not exclude the presence of infection, in the case of a recent infection.

Complete set

The product is a set of reagents, which includes::

1. Test cassette (individually wrapped in foil, complete with desiccant) – 20 pcs. ;

2. Test tube with buffer for dilution of biological sample-20 pcs. ;

3. Nozzle with dropper – 20 pcs.

4. Instructions for the medical device – 1 pc.

Special instructions

A medical device does not contain any medicinal products. The medical device is not sterile. The medical device is not subject to repair and maintenance.

Security measures1. 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 an extended period of time.

3. Do not use the test cassette 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 buffer contains less than 0.1% sodium azide. If the buffer 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. 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.

10. Do not use the medical device after the expiration date.

11. The medical device is not intended for repeated use.

12. When testing, it is forbidden to use components of the Kit from different series.

13. If you receive controversial (questionable) results, it is recommended to perform the analysis using alternative methods available in these clinical settings. 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.

14. When using liquid media for transporting samples containing viruses (UTM/VTM) for a smear sample taken from the nasopharynx, this medium must be diluted in a 1: 1 ratio with the diluent included in the delivery package. However, it should be taken into account that dilution may lead to a decrease in the sensitivity of the test system.

Storage conditions

• Store the test system in its original packaging at a temperature of 1-40 °C.
• The test system should be stored in an unopened packaging envelope until the analysis is performed immediately.
• Do not freeze it.
• The product can be transported by all types of covered transport in accordance with the transportation rules applicable for this type of transport, in the manufacturer’s packaging at a temperature of 1-40 °C.
• Products that are transported in violation of the temperature regime are not subject to use.

Expiration date

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

Material

Polymer

Gender

For men, For women

Form of production

Express test