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
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