Antibody Test | Lepu Medical - 20 pz

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Italy: La vendita dei Test Sierologici è destinata solo ad operatori sanitari. Pertanto Non possiamo vendere e dare informazioni a privati. I test possono essere eseguiti solo da personale medico. Acquistandoli si dichiara sotto propria responsabilità, di essere un operatore sanitario.
€ 183.00 EUR
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This covid-19 serological test can quickly show if a person developed antibodies following a Corona virus infection. The Leccurate test for Covid-19 (Sars-CoV-2) is based on the principle of antigen-antibody reaction and immunoassay technique. Kit containing 20 tests

Description

Test Rapido COVID-19 CE IVD
Immunocromatografia con oro colloidale

Pack of 20 tests

CONTENUTO DEL KIT
• 20 test confezionati singolarmente (striscia/cassetta test)
• 1 provetta contagocce con buffer diluente del campione
• 1 busta di pipette monouso
• Istruzioni per l’uso

The product is intended for qualitative detection of antibody content against SARS-CoV-2 through clinical samples (serum/plasma/whole blood).

Exempt from VAT pursuant to Article 124 of Legislative Decree no. 34 of 19 May 2020 (so-called Relaunch Decree).

Registrazione Ministero della Salute: 1936176

Accurato: alta-qualità anticorpi con alta accuratezza.
Efficiente: risultati dei testi in circa 15 minuti.
Conveniente: adatto per prelievo sangue da dito.

REAGENT INCLUDED IN THE PACKAGE

This product is for in vitro diagnostic use, CE certified.

COVID-19 EC IVD Rapid Test is based on the principle of antigen-antibody reaction and immunodosing technique. The test device contains recombinant SARS-CoV-2 collidal gold-labeled recombinant protein, immobilized human IgG antibody in the test area labeled G, immobilized human IgM antibody in the test area labeled M, and the corresponding immobilized control antibody in the test area labeled C.

During the assay, when the level of SARS-CoV-2 IgM antibodies in the sample is equal to or greater than the limit of detection of the assay, the IgM antibody present in the sample binds to the recombinant SARS-CoV-2 protein marked with colloidal gold and immobilized on a gold buffer. The protein-antibody duplicates migrate upward through the capillarity phenomenon and are captured by the immobilized human IgM antibody in the M test area and this produces a purple-red band in the M test area.

When the level of SARS-CoV-2 IgG antibodies in the sample is equal to or greater than the limit of detection of the assay, the IgG antibody present in the sample binds to the recombinant SARS-CoV-2 protein marked with colloidal gold and immobilized on a gold buffer. The protein-antibody duplicates migrate upward through the capillarity phenomenon and are captured by the immobilized human IgG antibody in the G test area and this produces a purple-red band in the G test area.

If the sample is negative, no red-purple band will appear in test areas M and G. In any case, in the presence of negative or positive samples, a red-purple band will appear in the test control area (C). This band acts as a quality control of the test and is a criterion for judging whether there is enough sample and whether the chromatography process is normal. It also serves as an internal control standard for reagents.

1

[Sample Type] Whole Blood / Plasma / Serum

Sample Volume] 20ul / 10ul / 10ul

[Reaction Time] 15 min

[Kit Contents] 20 tests in each box

[Storage Conditions] 4°C - 30°C

[Duration] 12 months

1

Antibodies are secreted as a result of viral infection. Immunoglobulins M (IgM) are the first to be produced as an initial response after infection. Immunoglobulin G (IgG), on the other hand, is produced later to create a more specific and longer lasting immune response against the virus.

how-to-test-rapid-codiv

Interpretation of results

interpret-test-rapid-covid

NOTES:
This figure is only used as a reference for judging results

INTERPRETATION OF RESULTS

POSITIVE IgG: * two colored lines appear. A colored line appears in the control area (C) and another line appears in the IgG test area.

POSITIVE IgM: * two colored lines appear. A colored line appears in the control area (C) and another line appears in the IgM test area.

IgG and POSITIVE IgM: * three colored lines appear. One colored line appears in the control area (C) and the other two appear in the IgG test area and the IgM test area.

* NOTE: The color intensity in the test line areas may vary depending on the concentration of 2019-nCoV antibodies present in the sample. Therefore, any shade of colour in the test line area should be considered positive.

NEGATIVE: A coloured line appears in the control area (C). No line appears in the IgG and IgM test area.

NON VALID TEST: The control line (C) is not displayed (the control line must always be visible). Insufficient sample volume or incorrect procedural techniques are the most likely reasons for control line failure. Re-examine the procedure and repeat the test. If the problem persists, discontinue use of the kit immediately.

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Antibody Test | Lepu Medical - 20 pz
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