ProDetect COVID-19 Antigen Rapid Self Test Oral Saliva Fluid
Intended use
ProDetect COVID-19 Antigen Rapid Self Test with Oral Saliva Fluid is a rapid lateral flow chromatographic immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens in human oral fluid specimens. The test serves as an aid in the diagnosis of coronavirus infection disease (COVID-19) for individuals suspected of SARS-CoV-2 infection.
ProDetect COVID-19 Antigen Rapid Test (Oral Fluid) is used in conjunction with clinical presentation and the results of other laboratory tests. ProDetect COVID-19 Antigen Rapid Test (Oral Fluid) is intended for professional use only.
Summary and explanation of the test
SARS-CoV-2 is associated with common symptoms included fever, cough, fatigue, shortness of breath or breathing difficulties, and loss of smell and taste. While most people have mild symptoms, some people develop acute respiratory distress syndrome (ARDS). It starts with mild symptoms for about a week and then progresses to rapid deterioration and ARDS requiring advanced life support.
ProDetect COVID-19 Antigen Rapid Test detects SARS-CoV-2 nucleocapsid protein antigens. During the acute phase of infection, an antigen is commonly detectable in the upper respiratory specimens.
Principle of the test
ProDetect COVID-19 Antigen Rapid Test is a qualitative membrane-based immunoassay for the detection of SARS-CoV-2 nucleocapsid protein antigens in human oral fluid specimen. During the testing, the specimen reacts with SARS-CoV-2 nucleocapsid protein antibody-coated particles in the test line region of the test cassette. The mixture then migrates upward on the membrane chromatographically by capillary action and reacts with SARS-CoV-2 nucleocapsid protein antibody in the test line region. A coloured line will appear in test line region if specimen contains SARS-CoV-2 antigens. If the specimen does not contain antigens to SARS-CoV-2, no coloured line will appear in the test line region, indicating a negative result. To serve as a procedure control, a coloured line will appear at the Control Region (C), indicating that the test has been performed properly.
Quality control
Although there is an internal procedural control line in the test device of the control region, the use of external controls is strongly recommended as Good Laboratory Testing Practice to confirm the test procedure and to verify proper test performance. Positive and negative control should give the expected results. When testing the positive and negative control, the same array procedure should be adopted. Positive or negative controls are not included in this kit.
Sensitivity and specificity
ProDetect COVID-19 Antigen Rapid Test (Oral Fluid) was compared with a leading commercial PCR kit. The results showed that the ProDetect COVID-19 Antigen Rapid Test has high sensitivity and specificity.
Reagents and materials supplied
Each set consists of the following components:
- One individually sealed pouch, each containing,
- One test device
- One desiccant pouch
- One collection device, each consisting of:
- One funnel
- One collection tube
- One dropper
- One biosafety bag
- One single use buffer
- One procedure card
- One leaflet with instruction for use
Each box consists of 20 sets.
Sample collection and preparation
Oral fluid specimen should be collected using the collection device provided with the kit. Do not use other collection devices. Oral fluid collected at any time of the day may be used. Specimens should be tested immediately after collection if possible. If the oral fluid is not processed immediately, it is stable up to 8 hours at room temperature and 24 hours at 2-8 degreeC.
Prior to collection of oral fluid, patients must not place anything in their mouth including food, drink, gum or tobacco products for at least 10 minutes before collection.
Step 1:
- Attach the funnel to the collection tube prior to sample collection.
- Instruct the patient to deeply cough 3-5 times to release sputum from deep throat to mouth and into the collection device. (Note: It is recommended to collect the first sputum after deep coughing in the morning.)
- Repeat the steps above for sample collection until the oral fluid reaches the scale line indicated on the collection tube.
- Remove excess oral fluid volume from the collection device using the dropper.
Step 2:
- Remove the funnel from collection tube.
- Empty the entire content of the disposable buffer into the collection tube.
- Place the cap securely on the collection tube. Gently squeeze the collection tube for 10 seconds to mix the sample with the buffer thoroughly. (Note: The storage of the specimen after extraction is stable for 2 bours at room temperature or 24 hours at 2-8 degreeC.)
Test procedures: Bring the device, buffer, and sample to room temperature (15-30 degreeC) prior to testing. Best results will be obtained if the test is performed immediately after opening the foil pouch.
- Remove test device from the foil pouch (use within 1 hour) and place it on a flat and clean surface.
- Transfer extracted sample to the test device.
- Wait for the coloured line(s) to appear.
- Read the results at 15 minutes.
- Do not read results after 20 minutes.
