Beright Antigen Rapid Test Kit

BERIGHT COVID-19 ANTIGEN RAPID TEST KIT

sales@covid19testkits.my www.covid19testkits.my +60 11 6210 5266

01 INTRODUCING

02 HOW TO USE

03 MARKET COMPARISON

04 APPROVAL MEDICAL DEVICE AUTHORITY MINISTRY OF HEALTH MALAYSIA

INTRODUCING EASY

Specimen collection

SIMPLE Easy operation, no equipment required

Evaluated by Makmal Kesihatan Awam Kebangsaan (MKAK)

93.1% Sensitivity 100% Specificity

Approved by:

KEMENTERIAN KESIHATAN MALAYSIA

15

FAST

Results in 15 minutes

HIGH

Accuracy

INTRODUCING ( INTENDED USE ) The COVID-19 Antigen Rapid Test (Oral Fluid) is a single use test kit intended to detect the novel coronavirus SARS CoV 2 that causes COVID 19 in human oral fluid. This test is designed for home use with self collected oral fluid samples from symptomatic individuals who are suspected of being infected with COVID 19.

The COVID 19 Antigen Rapid Test (Oral Fluid) obtain a preliminary results only, the final confirmation should be based on clinical diagnostic results.

( SUMMARY ) The novel coronaviruses belong to the β 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.

( PRINCIPLE )

( WARNING ) 1. Read the entire package insert prior to performing test.

2. For self testing in vitro diagnostic use only.

3. The test is for one time use only, do not reuse the test. Do not use after expiration date.

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

5. Do not drink the buffer in the kit. Carefully handle the buffer and avoid it contacting skin or eyes, rinse with plenty of running water immediately if contacting.

6. Do not use test if pouch is damaged.

7. Wash hands thoroughly before and after handling.

8. If the result is preliminary positive, share your test result with your healthcare provider and carefully follow your local COVID guidelines/requirements.

9. Test for children and young people should be used with an adult.

10. The used test should be discarded according to local regulations.

( STORAGE ) Store the test at 35.6-86 F (2 30 C). Do not open the pouch until ready for use. DO NOT FREEZE.

( ITEMS PROVIDED )

The COVID-19 Antigen Rapid Test ( Oral Fluid) is a qualitative membrane based immunoassay for the detection of SARS CoV 2 Antigens in human oral fluid specimen.

Test device | Buffer | Collection device (Funnel, tube and tube tip) | Package insert | Biosafety Bag

( REAGENTS )

( ITEMS NOT PROVIDED )

The test device contains anti SARS CoV 2 antibodies.

Timer

HOW TO USE ( TESTING ) Before Testing, do not place anything in the mouth including food, drink, gum or tobacco products for at least 10 minutes pri or to collection.

Wash your hands with soap and water for at least 20 seconds before testing. If soap and water are not available, use hand sanitizer with at least 60% alcohol.

2

1

4

3

scale line

Fit the funnel onto the tube.

Deeply cough 3 - 5 times.

Spit oral fluid into the funnel.

Remove the funnel and the oral fluid (non-bubble) should just reach the scale line.

Place the tube into the tube holder. Add entire disposable Buffer. Squeeze 10 - 15 times.

2 drops of mixed reagent into the test kit.

Wait for 15 minutes to view the result.

( READ RESULT ) Please share your test result with your healthcare provider and carefully follow your local COVID guidelines/requirements.

MARKET COMPARISON

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Product Name

Made in

Test Sample

Test Method

Beright

China

Saliva

Easy

93.10% 100%

ALLTest COVID

China

Saliva

Easy

91.38% 100%

N/A

Salixium

Malaysia

Nasal + Saliva

Nasal + Saliva

91.00% 100%

3-5 weeks

100-200 thousand

Gmate

Korea

Saliva

Easy

90.90% 100%

3-5 weeks

100-200 thousand

JustChek Covid

China

Saliva

Easy

NA

100%

1-2 weeks

N/A

1-2 million

N/A

N/A

APPROVAL MEDICAL DEVICE AUTHORITY MINISTRY OF HEALTH MALAYSIA

THANK YOU sales@covid19testkits.my www.covid19testkits.my +60 11 6210 5266