Description

INTRODUCTION

Coronaviruses can cause a variety of acute and chronic diseases. Common signs of a person infected with a coronavirus include respiratory symptoms, fever, cough, shortness of breath, and dyspnea. In more severe cases, infection can cause pneumonia, severe acute respiratory syndrome, kidney failure, and even death. The 2019 new coronavirus, or SARS‑CoV‑2, was discovered due to Wuhan viral pneumonia cases in 2019 and a pandemic was declared by the World Health Organization on March 11, 2020. WHO confirmed that COVID‑19 can cause colds and more serious diseases such as severe acute respiratory syndrome (SARS).

 

TEST PRINCIPLE

The SARS‑CoV‑2 Rapid Antigen Test has two pre‑coated lines: A “C” Control line and a “T” Test line on the surface of the nitrocellulose membrane. Both the control line and test line in the result window are not visible before applying any samples. Mouse monoclonal anti‑SARS‑CoV‑2 antibody is coated on the test line region and mouse monoclonal anti‑Chicken IgY antibody is coated on the control line region. Mouse monoclonal anti‑SARS‑CoV‑2 antibody conjugated with color particles are used as detectors for the SARS‑CoV‑2 antigen device. During the test, the SARS‑CoV‑2 antigen in the sample interacts with monoclonal anti‑SARS‑CoV‑2 antibody conjugated with color particles making an antigen‑antibody color particle complex. This complex migrates on the membrane via capillary action to the test line, where it is captured by the mouse monoclonal anti‑SARS‑CoV‑2 antibody. A colored test line becomes visible in the result window if anti‑SARS‑CoV‑2 antigens are present in the sample. The intensity of the colored test line varies depending upon the amount of anti‑SARS‑CoV‑2 antigen present in the sample

 

Note: Even if the test line is very faint or not uniform the test result should be interpreted as a positive result. If anti‑SARS‑CoV‑2 antigens are not present in the sample, no color appears in the test line. The control line is used for procedural control, and always appears if the test result is valid. If no control line is visible the test result should be considered as invalid.

 

INTENDED USE 

The SARS‑CoV‑2 Rapid Antigen Test is a rapid chromatographic immunoassay for the qualitative detection of specific antigens of SARS‑CoV‑2 present in the human nasopharynx. This test is intended to detect antigen from the SARS‑CoV‑2 virus in individuals suspected of COVID‑19. This product is strictly intended for professional use in laboratory and Point of Care environments.

 

REAGENTS

▪ mAb anti-COVID19 antibody ▪ mAb anti-Chicken IgY ▪ mAb anti-COVID-19 antibody‑gold conjugate ▪ Purified chicken IgY‑gold conjugate

 

MATERIALS PROVIDED

•  Test device (individually in a foil pouch with desiccant)
•  Extraction buffer tube
•  Nozzle cap
•  Sterile swab
•  Film (can be attached to the test device when performing outdoor testing)
•  Instructions for use
•  Quick Reference Guide

 

MATERIALS REQUIRED BUT NOT PROVIDED

Timer

 

STORAGE AND STABILITY

• Store the kit at 2‑30 °C / 36‑86 °F out of direct sunlight.
• Kit materials are stable until the expiry date printed on the outer box.
• Do not freeze the kit.

 

TEST PREPARATION

 

1. Check the expiry date on the back of the foil pouch. Do not use the test, if the expiry date has passed.
2. Open the foil pouch and remove the test device and the desiccant package. Use the test immediatedly after opening the pouch.
3. Ensure that the test device is undamaged and that the desiccant status indicator shows valid (yellow).
4. Perform a QC as required according to the Instructions for Use of the QC material.

 

COLLECTING SAMPLE (Nasopharyngeal swab)

 

1. To collect a nasopharyngeal swab sample, insert a sterile swab into the nostril of the patient, reaching the surface of the posterior nasopharynx. (1)
2. Using gentle rotation, push the swab until resistance is met at the level of the turbinate.
3. Rotate the swab a few times against the nasopharyngeal wall.
4. Remove the swab from the nostril carefully.
5. Insert the swab into the provided extraction buffer tube. While squeezing the buffer tube, stir the swab more than 5 times. (2.a)
6. Remove the swab while squeezing the sides of the tube to extract the liquid from the swab. (2.b)
7. Press the nozzle cap tightly onto the tube. (2.c)
8. The sample should be tested as soon as possible after collection.
9. Samples may be stored at room temperature for up to 1 hour or at 2‑8 °C/ 36‑46 °F for up to 4 hours prior to testing.

 

 

TEST PROCEDURE 

1. Apply 3 drops of extracted sample to the specimen well of the test device. (3.a)

2. Read the test result at 15‑30 minutes. Do not read test results after 30 minutes. It may give false results (3.b)

 

READING AND INTERPRETING RESULTS (4.)

▪ A colored line appears in the top section of the result window to show that the test is working properly. This line is the control line (C). Even if the control line is faint or not uniform, the test should be considered to be performed properly. If no control line is visible the test result should be considered as invalid.

 

▪ In case of a positive result, a colored line appears in the lower section of the result window. This line is the test line of the SARS‑CoV‑2 antigen (T). Even if the test line is very faint or not uniform the test result should be interpreted as a positive result.

 

WARNINGS 

•  Do not re‑use the test kit.
•  Do not use the test kit if the pouch is damaged or the seal is broken.
•  Do not use the extraction buffer tube of a different lot.
•  Do not smoke, drink or eat while handling sample.
•  Wear personal protective equipment, such as gloves and lab coats when handling kit reagents. Wash hands thoroughly after the tests are done.
• Clean up spills thoroughly using an appropriate disinfectant.
• Handle all samples as if they contain infectious agents.
• Observe established precautions against microbiological hazards throughout testing procedures.
• Dispose all samples and materials used to perform the test as biohazardous waste. Laboratory chemical and biohazardous wastes must be handled and discarded in accordance with all local, state, and national regulations.
• ▪ Desiccant in foil pouch is to absorb moisture and keep humidity from affecting products. If the desiccant status indicator changes from yellow to green, the test device in the pouch should be discarded.