Indicaid Covid 19 Antigen Rapid Test - 25 Count

The INDICAID™ COVID-19 Rapid Antigen Test is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct anterior nasal swab specimens from individuals who are suspected of COVID-19 by their healthcare provider within the first five (5) days of symptom onset or from individuals without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over two or three days with at least 24 hours and no more than 48 hours between tests.

Indicaid Covid 19 Antigen Rapid Test - 25 Count Features:

• Efficacy: 93% positive results, 98% false negatives
• Determinations: Detection of the SARS-CoV-2 nucleocapsid protein antigen
• Storage Requirements: 34° – 86° F
• CLIA Waived, FDA, EUA approved
• Minimally invasive specimen collection
• For in vitro diagnostic use only
• 25 Test Per Box
• Non-Returnable Item

KIT COMPONENTS INCLUDED:

• Test Devices (Qty 25): Individually foil pouched test device containing one test strip in a plastic device cassette. Each strip has one control line and one test line. 
• Buffer Solution Vials (Qty 25): Vial with cap and integrated dispensing tip, containing 400 μL of buffer solution. 
• Nasal Swabs (Qty 25): Individually wrapped, sterile specimen collector.
• Package Insert: 1 Instructions for Use, 1 Quick Reference Guide 

Instructions for use

Step 1:  Remove the Swab and Test Device from their packaging. Place the Test Device on a horizontal (flat) surface for running the test. 

Step 2: Insert the entire collection tip of the swab provided (usually ½ to ¾ of an inch, or 1 to 1.5 cm) inside the nostril.  Firmly sample the nasal wall by rotating the swab in a circular path against the nasal wall at least 4 times. Take approximately 15 seconds to collect the specimen. Be sure to collect any nasal drainage that may be present on the swab.  Repeat in the other nostril using the same swab. 

Step 3:The Buffer Solution Vial cap is composed of two parts (purple and white). Remove the entire cap. Stir the swab into the Buffer Solution, ensuring that the swab head is fully submerged by tilting the vial. Twist the swab back and forth 20 times in the Buffer Solution. Roll the swab head against the inner wall of the vial to release the liquid from the swab, then discard the swab. 

Step 4: Close the entire vial cap tightly. Immediately proceed to the Test Procedures to process the sample. 

Test Procedure

Step 1: Close the entire vial cap tightly. Immediately proceed to the Test Procedures to process the sample. 

Step 2: Hold the vial vertically above the sample well (S). Slowly squeeze and apply 3 drops of the Buffer Solution into the sample well (S) of the Test Device. 

Step 3: Read the test line (T) and control line (C) results promptly at 20 minutes, and not earlier to ensure proper test performance.  Results after 25 minutes should not be used.

Result Interpretation 

• Test results are interpreted visually, without the aid of instruments. 
• Positive Result 
  • The presence of both the red-colored control line (C) and red-colored test line (T) indicates the presence of SARS-CoV-2 antigen. The result suggests current SARS-CoV-2 infection. Samples with low levels of antigen may produce a faint test line. Any visible test line is considered positive. 
  • Additional confirmatory testing with a molecular test for positive results may be necessary if there is a low likelihood of SARS-CoV-2 infection, such as in individuals without known exposures to SARS-CoV-2 or residing in communities with low prevalence of infection. 
• Negative Result 
  • The presence of the red-colored control line (C) and no visible test line (T) indicates a negative result. No SARS-CoV-2 antigen was detected.