TITLE: SensingSelf S1 Rapid Antigen Test (Saliva/Sputum/Stool)
AUTHORS: Shripal Gandhi, Santo Purnama, Keyur Patel, Praveen Sukumara, Dr Rinu R Ravi

[DESCRIPTION]
<div class = "text-blocks"><div class = "text-block"><span style = "font-weight:bold;">Summary:</span></div><div class = "text-block">The S1 COVID-19 Rapid Antigen test kit developed by Sensing Self Pte. Ltd. can quickly and qualitatively detect the spike glycoprotein of novel coronavirus (SARS-COV-2) in human saliva/sputum/stool samples. It can be used as an aid for COVID-19 diagnosis.</div><div class = "text-block"><span style = "font-weight:bold;">Objective:</span></div><div class = "text-block">According to the clinical trial plan, the S1 COVID-19 Rapid Antigen test kit or “test reagent”, is to test saliva/sputum/stool samples from healthy subjects and confirmed COVID-19 patients. Test results are compared with another commercial SARS-COV-2 nucleic acid detection kit with CFDA approval, which is defined as the “gold standard”. The sensitivity, specificity, and total agreement rate are used to evaluate the feasibility of the test reagent in clinical applications.</div><div class = "text-block"><span style = "font-weight:bold;">Method:</span></div><div class = "text-block">A collection of clinical samples were examined by the S1 COVID-19 Rapid Antigen test kit and the gold standard SARS-COV-2 nucleic acid detection kit in parallel, to calculate the clinical sensitivity, clinical specificity and total agreement rate of the test reagent.</div><div class = "text-block"><span style = "font-weight:bold;">Results:</span></div><div class = "text-block">Compared to the gold standard, the clinical sensitivity of test reagent reached 90.0%, the clinical specificity reached 100.0%, and the total coincidence rate reached 95.0%.</div><div class = "text-block"><span style = "font-weight:bold;">Conclusions:</span></div><div class = "text-block">The performance of test reagent has a high agreement rate with the gold standard, proving its good feasibility in diagnosing suspected COVID-19 cases.</div><div class = "text-block">Some of the sample collection steps were adapted from the published protocol:</div><div class = "text-block"><a href="https://www.protocols.io/view/saliva-collection-and-rna-extraction-for-sars-cov-bh6mj9c6" style = "text-decoration:underline;color:blue;cursor:pointer;"><span style = ":;:UNDERLINE;">https://www.protocols.io/view/saliva-collection-and-rna-extraction-for-sars-cov-bh6mj9c6</span></a></div></div>

[STEPS]
?. [SALIVA SAMPLE COLLECTION]
Saliva should be collected with the assistance of a healthcare worker or technician.
?. [SALIVA SAMPLE COLLECTION]
Before collection, clean hands using alcohol-based sanitizer or soap and water (no fragrances) and wear appropriate PPE (at minimum, gloves and a mask).
?. [SALIVA SAMPLE COLLECTION]
While preparing collection materials, direct the sample provider to begin pooling saliva in their mouth. Saliva production can be stimulated by thinking about food (favorite foods, upcoming meals, etc.) or about the saliva collection itself.
This protocol is intended for the collection of the normal saliva that naturally pools into the mouth. No coughing or sniffing prior to sample collection is required.
Ideally, water should be avoided 10 minutes prior to collection. Other drinks, food, and nasal sprays should be avoided for half an hour before sample collection.
?. [SALIVA SAMPLE COLLECTION]
Once you have pooled saliva  in your mouth, gently expel saliva into the disposable paper cup.
?. [SPUTUM SAMPLE COLLECTION]
Educate the patient about the difference between sputum and oral secretions (saliva).
?. [SPUTUM SAMPLE COLLECTION]
Rinse the mouth with clean water. This is important to make sure there won’t be mouth bacteria in the sputum collected.
?. [SPUTUM SAMPLE COLLECTION]
Put one hand over the mouth with a tissue and put the other hand on your stomach.
?. [SPUTUM SAMPLE COLLECTION]
Cough deeply, so that you can really feel it in your stomach. Do not take shallow coughs from the throat or chest.
If you are having trouble-1. Get a pat- ask somebody to pat you solidly up and down your back to help you release the sputum.2. Stretch and try again- sometimes it helps to relax a bit. When you are ready, rinse and spit and try again.
?. [SPUTUM SAMPLE COLLECTION]
Once the sputum (phlegm) is in your mouth, release it into the disposable paper cup.
?. [STOOL SAMPLE COLLECTION]
Use disposable gloves while handling a stool sample. Stools can contain material that spreads infection.
?. [STOOL SAMPLE COLLECTION]
Do not collect the stool from the toilet. The stool must not have any contact with urine.
1. To ensure the stool does not come in contact with urine, pass urine before collecting the stool specimen.2. To ensure that the stool does not come in contact with the toilet bowl or water, loosely drape a long section of plastic wrap over the rim on both sides of the toilet bowl creating a “pocket” in the centre.
?. [STOOL SAMPLE COLLECTION]
With the help of a disposable sample extraction tube collect the required quantity of stool sample for further steps.
?. [TEST PROCEDURE]
Allow the test device and specimens to equilibrate to temperature (- or -) prior to testing.
15 °C
30 °C
59 °F
86 °F
?. [TEST PROCEDURE]
Stool Sample: Unscrew the sampling bottle, use the sampling rod to pick up  to  of fresh stool samples (equivalent to the size of a match head)；or swab the stool with a cotton swab. Sputum Sample: Unscrew the sampling bottle, use the sampling rod or a cotton swab to pick up   to  of fresh sputum samples.
?. [TEST PROCEDURE]
Put the sample collected into the tube and shake and mix completely.
?. [TEST PROCEDURE]
Take the test card from the packaging bag, place it on a table, cut off the protrusion of the collection tube, and add   of the sample into the sample hole vertically.
?. [TEST PROCEDURE]
Wait for the appearance of the red stripe on T line, read the result in  minutes, and judge it invalid after  minutes.
?. [TEST PROCEDURE]
Take the test card from the packaging bag, place it on a table, cut off the protrusion of the collection tube, and add  of the sample into the sample hole vertically.
[(approximately 3 drops)]
?. [INTERPRETATION OF RESULTS]
Positive (+): Both of T and C lines appear in  to  minutes. Negative (-): C-line appears while no T line appears in  minutes after the sample added.Invalid: As long as the C-line does not appear, it indicates that the test result is invalid, and should retest with another test card.