The INDICAID® COVID-19 Rapid Antigen Test (CE-IVD) is a lateral flow immunoassay designed for the qualitative detection of SARS-CoV-2 antigens in direct nasal swab samples.
Antigens are present in the SARS-CoV-2 virus, and can bound with specific antibodies.
When a virus enters a human body and begins to multiply, the body begins to react to the viral antigens, possibly resulting in symptoms.
The INDICAID® COVID-19 Rapid Antigen Test Rapid detects antigens from SARS-CoV-2 virus and can be used for COVID-19 screening during active infection
Instruction For Use
Open the package and take
out the test device.
Tilt your head back. Gently insert the swab about 1 nch into one of your nostrils.Twist for 5 seconds. Repeat with your other nostril.NEXT
Remove the entire cap. Stir the swab into the buffer solution 20 times.
Throw away the swab and screw back the cap.
Close the entire vial cap tightly.
Immediatly perform Steps 5-7.
Remove the top half of the vial
cap to expose the dropper tip.
Hold the vial vertically. Squeeze and drip 3 drops of the solution into the circular opening (S) of the test device.NEXT
Leave for 20 minutes and read the results. Do not read after 25 minutes. Refer to “Interpreting Your Results” section below.BACK
|A line appears in regions (C) and (T)||Positive||The presence of both the control line (C) and line (T) indicates the presence of SARS-CoV-2 antigens. The result suggests current COVID-19 infection.|
|A line appears in regions (C)||Negative||The presence of only the control line (C) and not the line (T) indicates no detection of SARS-CoV-2 antigens.|
|No line appears in regions (C)||Invalid||If the control line (C) does not appear, the result is invalid, regardless whether the line (T) is present. Repeat the test with a new test device.|
|Items per box||25x|
|Specimen type||Nasal and nasopharyngeal swab|
|Limit of detection||140 TCID50 / swab|
For deteremining the presence of SARS-CoV-2
antigens in direct nasal swab sampless
|Shelf life||12 months|
|Storage condition||2-30ºC. Do not freeze. Avoid direct sunlight|
The test is designed for using nasal swab samples.
Negative results do not rule out COVID-19 infection, especially if you have been in contact with the virus. Follow up molecular testing should be considered to rule out infection.
Positive results may be due to present infection with non SARS-CoV-2 coronavirus strains, such as SARS-CoV.
Results from antigen testing should not be used as the sole basis to diagnose or exclude COVID-19 infection.
Read the result at 20 minutes. Do not interpret the result after 25 minutes.
Please follow the product insert when testing.
Data / Performance
The performance of INDICAID® COVID-19 Rapid Antigen Test has been validated clinically. Below are the results of in-house and independent clinical validation.
INDICAID® COVID-19 Rapid Antigen Test limit of detection (LoD) was determined by testing limiting dilutions of inactivated SARS-CoV-2 virus in pooled human nasal matrix from presumed negative donors. Each test concentration was inoculated onto kit-provided swabs and processed according to the test procedure. The LoD was determined by confirming the lowest detectable concentration of SARS-CoV-2 at which 95% of the 20 replicates analyzed resulted in a positive test. The INDICAID® COVID-19 Rapid Antigen Test LoD in nasal matrix was confirmed to be 140 TCID50 per swab.
|Concentration (TCID50/swab)||Number of Positives/Total||% Detected|
Figure 1 - The results show that 100% detection of positive nasal samples can be achieved at the LoD of 140 TCID50 per swab.
The clinical performance of the INDICAID® COVID-19 Rapid Antigen Test was evaluated by testing 50 positive and 50 negative SARS-CoV-2 retrospective clinical specimens from unique donors that were previously confirmed by a molecular test. The 100 clinical specimens were nasopharyngeal swab samples eluted in saline. Testing was performed at one investigational site by two untrained operators who were blinded to the RT-PCR results of the samples. The samples were first randomized, then each sample eluate was inoculated onto kit-provided swabs and processed as instructed in test procedure. The INDICAID®COVID-19 Rapid Antigen Test correctly detected 48 / 50 positive samples and demonstrated no false positives for the negative samples.
Rapid Antigen Test
|Positive Percent Agreement (PPA)||96% (95% CI: 86.3% - 99.5%)|
|Negative Percent Agreement (NPA)||100% (95% CI: 92.9% - 100%)|
Figure 2 – The results show that INDICAID® COVID-19 Rapid Antigen Test reaches a positive percent agreement of 96% and a negative percent agreement of 100% with regard to the results of RT-PCR.
Frequently Asked Questions (FAQs)
a. I accidentally spilled the test solution. Is it harmful?
If the test solutions have been spilled, flush abundantly with water upon disposal. Avoid having the test solutions come into contact with your eyes, skin and mouth. If contact occurs with the eyes, flush with water immediately and seek medical help. If contact occurs with your skin, wash the area with soap and rinse with water.
Do not ingest or inhale the test solutions. If accidental ingestion occurs, please seek medical help immediately.
e. What if I tested negative?
Rapid antigen tests can only detect the presence of antigens at the time of the test. A false negative result may be produced when the level of antigen in the sample is below the detection limit of the test, the sample is collected improperly, or when the test was performed incorrectly. If you had contact with a known or suspected COVID-19 cases, as a best practice, performing the test at least once every week is recommended.
|User Manual||INDICAID® Rapid Antigen Test User Manual (CE P/I 2110200)|
|Quick Start Protocol||INDICAID® Rapid Antigen Test Quick Start Protocol (CE P/I 2110200)|
|Product Catalogue||INDICAID® Rapid Antigen Test Product Catalogue (CE P/I 2110200)|
|Safety Data Sheets (SDS)|
Product Sales and Customer Services
|Email : firstname.lastname@example.org|||||Customer Service :||Hong Kong||+852 3892-7200 (9am - 6pm UTC+8)|
|US||+1 (657) 233-5880 (9am - 6pm Pacific)|
|Technical Support :||Hong Kong||+852 9135-2170 (9am - 6pm UTC+8)|
|US||+1 (657) 296-6106 (9am - 6pm Pacific)|
|Customer Service :||
Hong Kong +852 3892-7200
(9am - 6pm UTC+8)
US +1 (657) 233-5880
(9am - 6pm Pacific)
|Technical Support :||
Hong Kong +852 9135-2170
(9am - 6pm UTC+8)
US +1 (657) 296-6106
(9am - 6pm Pacific)