COVID-19 Self-test Kit

• A convenient and safe option to perform SARS-CoV-2 testing privately at your home for yourself or family members.
• The self testing kit includes everything that you need to perform the assay: 2 sets of test cards, sampling swabs, tubes with buffer solution, and instructions.
• The self testing kit brings accurate results from nasal (anterior nares) swabs. This type of sample is simple to take from the front of the nose without having the need to perform deep naso or oropharyngeal swabbing.
• With frequent and regular testing further spread of the virus can be reduced and employees can feel safer to return to work.

 Intended use of the Covid Self test kit

The Camtech COVID-19 Antigen Rapid Self-Test kit is intended for self-testing for the in-vitro qualitative detection of the SARS-COV-2 antigen in human anterior nares (nasal) specimen. The fast testing procedure, high sensitivity and simple operation makes this rapid self-test kit a preferred method to detect acute cases of SARS-CoV-Z infection.

It is recommended that the test be done before the 7th day after the onset of symptoms.

COVID-19 is an acute respiratory infectious disease to which people are generally susceptible. Patients infected by the novel coronavirus, SARS-CoV-2 are the main source of infection; asymptomatic infected people can also be an infectious source. Based on the current epidemiological investigations, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations of the disease include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases.

The kit should only be used as a supplementary indicator or used in conjunction with nucleic acid detection in the diagnosis of suspected COVID-19 cases.

•   How to/Instructions on Using a Covid Self Test Kit

STEP 1

Before you start testing, wash your hands or use hand sanitizer. Make sure your hands are dry before starting.

STEP 2

Take out the test pouch and other provided materials and lay them on the table to prepare for use. Perform the test at room temperature and 30%-50% humidity for best results.

STEP 3

Remove cap from one of the tubes and discard the cap.

STEP 4

Place tube in the tube holder.

STEP 5

Remove the swab from its wrapper, being careful not to touch the soft end, which is the absorbent tip

STEP 6

Swab the Nostrils

1. Insert the entire absorbent tip of the swab into the nostril, but do not insert the swab more than 3A of an inch (1.5 cm) into the nose.
2. Slowly rotate the swab in a circular path against the inside of the nostril at least 4 times for a total of 15 seconds. Be sure to collect any nasal secretion that may be present on the swab.
3. Gently remove the swab.
4. Using the same swab, repeat steps a to b in the other nostril.

STEP 7

Place Swab in the Tube

1. Immediately place the swab into the liquid inside the tube, and ensure it is touching the bottom of the tube.
2. Leave the swab in the solution for 1 minute.
3. Stir 8 – 10 times.

STEP 8

After one minute, Remove the swab while squeezing wall of the tube against the swab while

rotating the swab, to extract the nasal secretions from the swab.

STEP 9

Dispose the swab in the disposable Ziplock bag provided.

STEP 10

Close up the tube firmly using the attached tip.

Push down the attached tip until you hear a “click” sound

STEP 11

Mix thoroughly by flicking the bottom of the tube.

STEP 12

Take out the test card from the test pouch

STEP 13

Hold the tube vertically and squeeze 4 drops of the solution onto the sample well (S) of the test card by squeezing the wall of the test tube.

STEP 14

Wait for 15 minutes after adding the sample solution into the well of the test card and interpret the results. Do not evaluate the result more than 20 minutes after dropping the solution into the well.

 Result Interpretation

Check your results

There are three types of results possible: Positive, negative and invalid result

Positive result: if both the quality control line (C) and the detection line (T) appear, novel coronavirus antigen has been detected and the result is positive for antigen.	Negative result: if there is only a quality control line (C) and the detection line (T) is colorless, indicating that the novel coronavirus antigen has not been detected and the result is negative.	Invalid result: if the quality control line (C) is not observed, the test is invalid regardless of whether or not there is detection line T (as shown in the figure).  Repeat the test with a new unused test card and new nasal sample.

 Limitations of the Covid Self-test kit

• This kit is only used for in-vitro diagnosis in a home use setting.
• This kit is only used for detecting extracts from human nasal swab samples. The results from other sample types are not suitable.
• This product is only used for qualitative detection and cannot indicate the level of SARS-CoV-2 antigen in the specimen.
• This kit is only a clinical auxiliary diagnostic tool. If the result is positive, it is recommended to use other methods for further examination according to doctor’s instructions.

 

Precautions to be taken during Covid Self-test at Home

• Read the instructions carefully before using the kit, and carefully measure the time before evaluation.
• The collected samples may be contagious. The processing and testing operations of the samples should be performed in compliance with local relevant biosafety regulations.
• Guard against moisture, do not open the test pouch before it is ready for testing. Do not use the test kit if the pouch is damaged or the test card is damp.
• Please use the kit within the validity period.
• Bring all reagents and specimens to room temperature (15 – 30°C) before use.
• Do not replace the components in this kit with components in other kits.
• Do not dilute the specimen for testing, otherwise you may get inaccurate results.
• The kit must be stored in strict accordance with the conditions specified in this manual. Please do not store the kit under freezing conditions.
• The test methods and results must be interpreted in strict accordance with this instruction manual.
• Negative results will occur with this kit if the novel coronavirus antigen titer in the specimen falls below the minimum detection limit for this kit.