BIOSYNEX COVID-19 Ag BSS SARS-CoV 2 Rapid Antigen Tests

Product Description

BIOSYNEX COVID-19 Ag BSS SARS-CoV 2 Rapid Antigen Tests (25)

The test should be carried out by a healthcare professional.

Biosynex Covid-19 Ag BSS Rapid test is a rapid in vitro immunochromatographic assay for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal swab specimens. BIOSYNEX COVID-19 Ag BSS SARS-CoV 2 Rapid Antigen Tests It is intended to aid in the rapid diagnosis of SARS-CoV-2 infections.

The BIOSYNEX COVID-19 Ag BSS test does not differentiate between SARS-CoV and SARS-CoV-2.

BENEFITS

Only few steps from sample to result.

All needed components are supplied with the test kit.

Room temperature storage.

Sensitivity 96%, Specificity 100%.

No cross-reactivity against other common respiratory viruses.

The result is ready in 15 minutes, can be read up to 20 minutes.

SUMMARY

The novel coronaviruses belong to the genus. COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel coronavirus are the main source of infection; asymptomatic infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases.

This test is for detection of SARS-CoV-2 nucleocapsid protein antigen.BIOSYNEX COVID-19 Ag BSS SARS-CoV 2 Rapid Antigen Tests   Antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Rapid diagnosis of SARS-CoV-2 infection will help healthcare professionals to treat patients and control the disease more efficiently and effectively.

PRINCIPLE OF THE TEST

The BIOSYNEX COVID-19 Ag BSS test is an immunochromatographic membrane assay that uses highly sensitive monoclonal antibodies to detect nucleocapsid protein from SARS-CoV-2 in nasopharyngeal (NP) swab. The test strip is composed of the following parts: namely sample pad, reagent pad, reaction membrane, and absorbing pad. The reagent pad contains the colloidal-gold conjugated with the monoclonal antibodies against the nucleocapsid protein of SARS-CoV-2; the reaction membrane contains the secondary antibodies for nucleocapsid protein of SARS-CoV2. The whole strip is fixed inside a plastic device. When the sample is added into the sample well, conjugates dried in the reagent pad are dissolved and migrate along with the sample. If SARS-CoV-2 antigen is present in the sample, a complex formed between the anti-SARS-CoV-2 conjugate and the virus will be captured by the specific anti-SARS-CoV-2 monoclonal antibodies coated on the test line region (T). Absence of the T line suggests a negative result. To serve as a procedural control, a red line will always appear in the control line region (C) indicating that proper volume of sample has been added and membrane wicking has occurred.

PRECAUTIONS

For professional in vitro diagnostic use only. Do not use after expiration date.

Do not eat, drink or smoke in the area where the specimens or kits are handled.

Handle all specimens as if they contain infectious agents. Observe established precautions against microbiological hazards throughout the procedure and follow the standard procedures for proper disposal of specimens.

Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are assayed.

The used tests, specimens and potentially contaminated material should be discarded according to the local regulations. Humidity and temperature can adversely affect results.

The extraction buffer contains a solution with a preservative (0.09% sodium azide). If solution comes in contact with the skin or eyes, flush with ample volumes of water.

Solutions that contain sodium azide may react explosively with lead or copper plumbing. Use large quantities of water to flush discarded solutions down a sink.

Do not interchange or mix components from different kit lots.

When collecting a nasopharyngeal swab sample, use the nasopharyngeal swab supplied in the kit.

To obtain accurate results, do not use visually bloody or overly viscous samples.

The test device should remain in the sealed pouch until use.

Swabs, tubes and test device are for single use only.

STORAGE AND STABILITY

The kit can be stored at room temperature or refrigerated (2-30C).

Do not freeze any of the test kit components.

Do not use test device and reagents after expiration date.

Test devices that have been outside of the sealed pouch for more than 1 hour should be discarded.

CONTENTS

Complete kit for carrying out 25 tests:

25 x Test cassettes

2 x Buffer vials

25 x Sterile Swabs

25 x Extraction tubes

25 x Nozzles

Workstation

Package insert