|Sample:||Oral Sample Sputum Saliva||Usage:||In Vitro Diagnostic Use.|
|Result Time:||15 Mins||Machine:||Qualitative Result, No Need Extra Machine.|
|Temperature:||Room Temperature 4-30℃||Origin:||Guangdong, China|
A new way for sample collection in rapid test diagnosis!
Fast: 15 Minutes
Easy: Easy sample collection;
Safe: Non-invasive sample collection reduces the risk of infection;
Stable: Saliva sample is stable at room temperature for convenient transportation;
Flexible: Sample can be easily collected in the laboratory, outpatient clinic, and even at home;
Widely used: Especially workable for children and patients whom cannot easily collect blood sample from.
MAIN CONTENTS OF SALIVA TEST
• Rapid Test Cassette.
• Specimen Collection Kit.
• Instructions for use.
INTENDED USE OF SALIVA TEST
The product is used for the qualitative detection of SARS-COV-2 infection. The entire detection process takes only 15-20 minutes, and the operation is simple and sensitive. No instrument required. It can be used for the screening of early infected patients and asymptomatic patients. This method is an effective supplement for nucleic acid detection.
PRINCIPLE OF COVID-19 ANTIGEN RAPID TEST
The product is a qualitative membrane-based immunoassay for the detection of SARS-CoV-2 Antigens in human Oral Fluid specimen. SARS-CoV-2 antibody is coated in the test line region. During testing, the specimen reacts with SARS-CoV-2 antibody-coated particles in the test. The mixture then migrates upward on the membrane by capillary action and reacts with the SARS-CoV-2antibody in test line region. If the specimen contains SARS-CoV-2 Antigens, a colored line will appear in test line region as a result of this. If the specimen does not contain antigens to SARS-CoV-2, no colored line will appear in the test line region, indicating a negative result. To serve as a procedural control, a colored line will always appear in the control line region, indicating that the proper volume of specimen has been added and membrane wicking has occurred.
STORAGE AND SHELF LIFE OF RAPID TEST KIT
• Store at 39~ 86 º F (4 ~ 30 º C) in the sealed pouch for 18 months.
• Keep away from direct sunlight, moisture and heat.
• DO NOT FREEZE.
OPERATION PROCEDURE OF RAPID TEST KIT
It is recommended to collect the first sputum after deep coughing in the morning.
① Use specimen collection kit to collect oral fluid specimen into preservation solution.
② Gently shake the mixture.
Remove the test cassette from the sealed foil pouch and use it within one hour. Best results will be obtained if the test is performed immediately after opening the foil pouch.
③ Add Extracted specimento the Test Device, Wait for the colored line(s) to appear.
Read the result at 15 minutes. Do not interpret the result after 20 minutes.
PERFORMANCE CHARACTERISTIC OF RAPID TEST KIT
Clinical Sensitivity, Specificity and Accuracy
The COVID-19 Antigen Rapid Test (Oral Fluid) has been evaluated with specimens obtained from the patients. RT-PCR is used as the reference method for the COVID-19 Antigen Rapid Test (Oral Fluid). Specimens were considered positive if RT-PCR indicated a positive result. Specimens were considered negative if RT-PCR indicated a negative result.
PLEASE NOTE THAT ORAL FLUID SAMPLE IS NOT AS ACCURATE AS SWAB SAMPLE.