CE/ISO/Bfarm COVID Saliva Antigen Test kit

INTENDED USE CE/ISO/Bfarm COVID Saliva Antigen Test kit is a rapid chromatographic immunoassay for the qualitative detection of novel coronavirus SARS-CoV-2 in human throat and nasal secretions, and saliva specimen. Brief Introduction The SARS-CoV-2 Antigen Rapid Test is for detection of SARS-CoV-2 antigens. Anti-SARS-CoV-2 monoclonal antibodies are coated in the test line and conjugated with the colloidal gold. During testing, the specimen reacts with the anti-SARS-CoV-2 antibodies conjugate in the test strip. The mixture then migrates upward on the membrane chromatographically by capillary action and reacts with another Anti-SARS-CoV-2 monoclonal antibodies in the test region. The complex is captured and forming a colored line in the Test line region. The SARS-CoV-2 Antigen Rapid Test contains anti-SARS-CoV-2 monoclonal antibodies conjugated particles and another anti-SARS-CoV-2 monoclonal antibodies are coated in the test line regions. SPECIMEN COLLECTION AND PREPARATION The SARS-CoV-2 Antigen Rapid Test (COVID- 19 Ag) can be performed using nasopharyngeal or oropharynx swab, nasal swab and saliva.  Nasopharyngeal Swab: Insert the sterile swab into the deep nasal cavity until the nasopharynx. Gently rub and rotate the swab against wall of turbinate for several times.  Oropharynx Swab: Insert the sterile swab into the throat. Gently scrape the secretions around the wall of pharynx and tonsil.  Nasal Swab: Insert the sterile swab into one of the nostrils around 2.5cm. Gentally rub against the anterior nasal wall and repeat the actions into the other nostril.  Saliva: Prepare a specimen collection container. Make a “Kruuua” noise from the throat, to get out the saliva or sputum from the deep throat. Then spit saliva (about 1-2ml) into the container. Morning saliva is optimal for saliva collection. Do not brush the teeth, eat food or drink before collection the saliva specimen. Take out of an assay buffer tube, and tear off the head of the tube. Extrude all the liquid (around 0.5ml) into a specimen collection tube.Insert the swab into the tube and squeeze the flexible tube to extrude the specimen from the head of the swab. Make the specimen resolved in the assay buffer sufficiently. Add the tip onto the specimen collection tube. If saliva specimen, suck the saliva from the container and place 5 drops (approx.200ul) of the saliva into the sample collection tube. The assay should be performed immediately in 2 hours after the specimen preparation. If the assay could not be carried immediately, the prepared specimen should be kept no more than 24 hours at 2-8°C or 7 ays at -20°C. Bring specimens to room temperature prior to testing. Frozen specimens must be completely thawed and mixed well prior to testing. Specimens should not be frozen and thawed repeatedly for more than two times. If specimens are to be shipped, they should be packed in compliance with federal regulations covering the transportation of etiologic agents. COMPONENTS Materials Provided 1) Foil pouches, each contains one test cassettes, one disposable dropper and one desiccant bag 2) Assay buffer tubes (0.5ml each) 3) Sterile swabs (each bag contains one nasopharyngeal swab and one oropharynx swab) 4) Specimen collection tubes with tips 5) Instruction for use Materials Required But Not Provided 1) Specimen collection container 2) Timer   TEST PROCEDURE Allow the test device, specimen, buffer, and/or controls to equilibrate to room temperature (15-30°C) prior to testing. 1. Bring the pouch to room temperature before opening. Remove the test device from the sealed pouch and use it as soon as possible. 2. Place the test device on a clean and horizontal surface. Reverse the specimen collection tube, extrude 3 drops of the prepared specimen into the specimen well (S) of the test cassette and start the timer. See illustration below. 3. Wait for the colored line(s) to appear. Read results at 10 minutes. Do not interpret the result after 15 minutes. INTERPRETATION OF RESULTS Positive (+): Two colored lines appear. One colored line should always appear in the control line region (C) and another line should be in the T line region. *NOTE: The intensity of the color in the test line regions may vary depending on the concentration of SARS-CoV-2 present in the specimen. Therefore, any shade of color in the test line region should be considered positive and recorded as such. - Negative (-): One colored line appears in the control line region (C). No line appears in the T line region. - Invalid: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test. If the problem persists, discontinue using   FAQ 1. What's the order process? 1) Enquiry---pls. send us your enquiry with estimate order qty and package requirement 2) Quotation---generally we will quote you within 24hrs, for OEM products, within 2 days 3) Samples --- we will send you sample upon your requirement, generally the sample is free of charge and need you cover the freight cost 4) Order & Production---after get your price & sample confirmation, you can send us your formal order to us, and we will send you SC for both party agreement. Generally we will start production after get your 30% deposit payment. 5) Inspection & Shipping---we will make 100% material inspection and finished production quality check, and send you cargo picture for your record. After get your approval we will book shipment for you, by sea or by air. 2. What kind of paymentterms you use? T/T,100% irrevocable L/C, credit card,west union 3.What is the average delivery time? Sample usually takes about 3-7 days. Mass production lead time is 20-30 days, more days should be considered for first production and CNY holiday.