Antigen Saliva Test Kit

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Professional Team

REALY has a development department dedicated to the development of IVD reagents. Our technical staff is responsible for process development, process improvement, and formulation development.

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We have CE certificates, ISO 13485 quality system certification, Manufacture License, and Marketing Authorization in the country of origin. We are also preparing the FDA and other certificates.

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Maintain strict quality control during the process. Our product safety is checked through extensive testing, sampling and verification procedures to meet final product specifications.

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We participate in medical exhibitions in many countries such as Medlab, Medica, and AACC every year. The sales network has covered more than 80 countries and regions, distributing high-quality products at very competitive prices.

What is Antigen Saliva Test Kit?

The COVID-19 Antigen Saliva Test Kit is an in vitro immunoassay that detects SARS-CoV-2 variant alpha, beta, gamma, kappa and delta. The kit is for the direct and qualitative detection of SARS-CoV-2 viral nucleoprotein antigens from human saliva samples collected from individuals suspected of having COVID-19 within the first 7 days of symptom onset. The COVID-19 Antigen Saliva Test Kit is intended for use by laypersons and enables self-testing at home. The test identifies SARS-CoV-2 viral nucleoprotein antigen. Antigen is generally detectable in saliva samples during the acute phase of infection.

Principle of Antigen Saliva Test Kit

The COVID-19 Antigen Saliva Test is a qualitative membrane-based immunoassay for the detection of SARS-CoV-2 antigens in human saliva samples. When the antigen in the sample reaches the Test area (T) of the membrane, it will form a coloured line. Absence of this coloured line suggests a negative result. To ensure the test is carried out properly, a coloured line will appear at the Control area (C), if the test has been performed correctly.

Benefits of Saliva Testing

Saliva Provides Improved Safety Through Non-Invasive Collection
Nasopharyngeal swabbing has been the “go-to” sampling method for viral testing since the COVID-19 pandemic began, but one major advantage to saliva collection and testing is that it is a non-invasive collection method. This fact alone is capturing the interest of both the healthcare provider and the end user. As saliva diagnostics has started to be used for SARS-CoV-2 testing, advantages over nasopharyngeal swabbing have become apparent.

Saliva is an Easier Sample Type to Self-Administer
The collection of saliva is much easier, more flexible, and introduces the option of convenient self-collection by a patient while in the presence of a health care provider. Decentralized collection and expanding test sites enable the sampling of a wider and more diverse population.

Better Stability and Transportability
As long as there is a way to transport samples from a patient’s residence to a testing facility, a decentralized testing system provides significant advantages. With SARS-CoV-2 testing, many emergency authorized tests have implemented at-home kits that use saliva collection methods and several studies have demonstrated the stability of SARS-CoV-2 RNA in saliva, under a variety of storage conditions.

Saliva Sampling is an Affordable Solution
Several studies have reported the cost-effective nature of saliva sampling compared to blood sampling. The price of extraction and purification of select salivary biomarkers is also lower: For commercial extraction of DNA from saliva, the cost is $6.93 per sample versus $10.88 per sample for blood.

Accurate Detection of Oral and Systemic Disease Biomarkers
Saliva is a complex biofluid with a vast array of diverse biomarkers present. The number of salivary biomarkers for oral and systemic diseases is increasing and sensitive, selective methodologies have aided in their detection. DNA, RNA, and protein biomarkers associated with cancer, periodontal disease, autoimmune diseases, viral and bacterial diseases, neurodegenerative diseases, and cardiovascular diseases have been identified in saliva.

Components of Antigen Saliva Test Kit

COVID-19 Antigen Saliva Test Kit: The kit consists ofsaliva collector, teststrip and extraction buffer. Strips inside the housing contain small amounts of chemicals (proteins, surfactants, biological buffers, salts, carbohydrates, polymers, latex particles and preservative (sodium azide)) and small amounts of antibodies or antigens as active ingredients of the detection reaction, conjugated to latex particles or immobilised on the test line regions. The membrane is nitrocellulose. The strip further contains adsorbent pads (cellulose), polyester and glass fiber. The saliva collector of each kit is made of polyester fiber. Buffer Components: Biological buffer,salts and surfactants. Preservatives: Sodium azide.

Coated Aluminum Foil for single pouched test kit.

Package insert (paper).

Test Procedure of Antigen Saliva Test Kit

Bring testkits, reagents and specimens and/or controls to room temperature (2 ~ 30°C) before use.

01/

Remove the testkit from its packing. Label the device with the patient’s identification. For the best results, the assay should be performed within two hours.

02/

Take the testkit out of the tube with extraction buffer. Remove the protection cap.

03/

Place the saliva collector( the circle part in the picture) at the back of the mouth. Keep the top of the device pointing up, to be in an angle to the horizontal line. Hold for 2 minutes.

04/

Take the saliva collector out of the mouth.

05/

Place the saliva collector vertically into the tube with extraction buffer.

06/

Read the results at 15 minutes.

Result Interpretation of Antigen Saliva Test Kit

Positive

Two colored bands appear on the membrane. One band appears in the control region (C), and another band appears in the test region (T).

Negative

Only one colored band appears in the control region (C). No apparent colored band appears in the test region (T).

Invalid

Control band fails to appear. Results from any test which has not produced a control band at the specified read time must be discarded. Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and contact your local distributor.

NOTE

The color intensity in the test region (T) may vary depending on the concentration of analytes present in the specimen. Therefore, any shade of color in the test region should be considered positive.
Insufficient specimen volume, incorrect operating procedure or expired tests are the most likely reasons for control band failure.

Precautions of Antigen Saliva Test Kit

Please read all the information in the package insert before performing the test.
For self-testing in vitro diagnostic use only.
Do not eat, drink or smoke in the area where the specimens or kits are handled.
Store in a dry place at2-30℃ (36-86F), avoiding areas of excess moisture.
If the foil packaging is damaged or has been opened, please do not use.
Use the test only once. Do not dismantle and touch the test window of the lolly test.
The kit must not be frozen or used after the expiration date printed on the package.
Wash hands thoroughly before and after handling.
Please ensure that an appropriate amount of samples are used for testing. Too much or too little sample size may lead to deviation of results.
All tests, samples and potentially contaminated materials used should be disposed of in the disposal bag provided with the test in the appropriate waste stream bin and wash your hands.

Limitations of Antigen Saliva Test Kit

Failure to follow the testing steps may give inaccurate results. This COVID-19 Antigen Rapid Test is for self-testing in vitro diagnostic use only.

The results obtained with the test should be considered with other clinical findings from other laboratory tests and evaluations, where available.

If the test result is negative or non-reactive and clinical symptoms persist, it may be because you are at the very early phase of infection and the virus may not be detected. It is recommended to test again with a new test 1-2 days later or seek medical advice.

Positive results of COVID-19 may be due to infection with nonSARS-CoV-2 coronavirus strains or other interference factors.

This COVID-19 Antigen Rapid Test is less reliable in the later phase of infection and asymptomatic people, it is recommended to use the test within the first 7 days of symptom onset.

Storage and Shelf Life

The test kit should be stored at 2-30℃, and the shelf life is 18 months.
After the aluminum foil pouch is unsealed, it is recommended to use the test card within 1 hour at room temperature.
The extraction solution is recommended to be used within 1 hour after opening at room temperature.

Our certificate

We have passed various certificates such as CE and ISO, and the products we provide have quality assurance.

Common Problems of Antigen Saliva Test Kit

Q: How do you use the antigen saliva test kit?

A: 30 minutes before saliva collection procedure, DO NOT eat, drink, smoke or chew gum. Remove the cassette from the sealed foil pouch and use it within 15 minutes. Swab the flat pad in the mouth and tongue to collect oral fluid. Take the flat pad out from the mouth when the purple color move across the result window in the center of the cassette.

Q: What are saliva antigen test results?

A: A positive result indicates the presence of viral antigens and additional testing is necessary. Positive results do not rule out bacterial infection or coinfection with other viruses. A negative result should be treated as presumptive and does not rule out COVID-19 infection. Negative results should be considered in the context of a patient's recent exposures, history, and the presence of clinical signs and symptoms consistent with COVID-19. If necessary, confirm with a molecular assay. The Test Card is intended for use in the first 7 days of symptom onset. The COVID-19 Antigen Saliva Test is intended for use by laypersons and enables self-testing at home or other locations.

Q: What can be detected in a saliva test?

A: Saliva testing is used to screen for or diagnose numerous conditions and disease states, including Cushing's disease, anovulation, HIV, cancer, parasites, hypogonadism, and allergies. Salivary testing has even been used by the U.S. government to assess circadian rhythm shifts in astronauts before flight and to evaluate hormonal profiles of soldiers undergoing military survival training.

Q: Are saliva antigen tests effective?

A: The diagnostic odds ratio was calculated at 87 (95% CI 19-395) and area under the curve was calculated as 0.92 (95% CI 0.90-0.94) suggesting very good performance of the saliva tests in detecting SARS-CoV-2. Conclusion: Saliva testing has a very good discriminative and diagnostic ability to detect of SARS-CoV-2.

Q: How accurate is the saliva test for COVID?

A: The saliva test is not an alternative to the nose and throat COVID-19 PCR test, which is still the most accurate diagnostic test for anyone who is suspected of having COVID-19. Although the laboratory testing process is the same, a saliva sample is only about 85 per cent as accurate as a nose and throat swab.

Q: Which rat is better nasal or saliva?

A: Out of 2819 participants, 6.5% had a positive molecular test. Overall sensitivities were 46.7% (39.3–54.2%) for the saliva Ag-RDT and 68.9% (61.6–75.6%) for the nasal Ag-RDT. With a viral load cut-off (≥ 5.2 log10 SARS-CoV-2 E-gene copies/mL) as a proxy of infectiousness, these sensitivities increased to 54.9% (46.4–63.3%) and 83.9% (76.9–89.5%), respectively.

Q: What does a positive COVID test look like?

A: A POSITIVE result must show BOTH a BLUE line and a PINK line just below the BLUE line. Look closely! Even a very faint, pink Test Line and a blue Control Line is a POSITIVE result. Pink shading or a line near the labels on the strip is not considered a positive result. You do not need to perform repeat testing if you have a positive result at any time.

Q: What is the purpose of a saliva test?

A: Accurate detection of oral and systemic disease biomarkers. DNA, RNA, and protein biomarkers associated with cancer, periodontal disease, autoimmune diseases, viral and bacterial diseases, neurodegenerative diseases, and cardiovascular diseases have been identified in saliva.

Q: How do you read Covid 19 antigen saliva test?

A: The presence of a colored band in the test region indicates a positive result for the SARS-CoV-2 viral antigens, while its absence indicates a negative result. A colored band at the control region serves as a procedural control, generally indicating that the proper volume of specimen has been added and membrane wicking is working.

Q: What is the difference between antigen test and PCR test?

A: Unlike the PCR test, the antigen test can only determine if you have an active virus in your body. The rapid test can’t detect small amounts of the virus or asymptomatic cases as accurately as the PCR test can.

Q: Can you do a COVID test in your throat?

A: Some people perform a throat swab to test for COVID at home using antigen tests. A throat swab is possibly better at detecting COVID than nasal swabs. Newer variants like Omicron are typically more detectable in your saliva than in your nostrils. Still, the Food and Drug Administration has not approved the throat swab method for at-home antigen tests as of 2023. It's essential that you follow the instructions to lower your risk of an inconclusive or false result.

Q: How long do saliva samples last?

A: The saliva collection kit includes a buffer solution that is added to your saliva immediately after you finish providing your sample. This solution stabilizes the DNA and prevents bacterial contamination. Buffered samples are stable at a wide range of temperatures (-4ºF to 122ºF or -20ºC to 50ºC) for up to 6 months.

Q: Is saliva testing more accurate than blood testing?

A: Consider putting away the syringe, relieving the patient of the fear and discomfort of a needle stick, and collecting saliva samples instead. Not only are today's saliva tests highly sensitive and accurate, but saliva diagnostics also offer the most reliable method for measuring levels of free, bioavailable hormones.

Q: What is the difference between rapid antigen test and swab test?

A: Antigen Test. It is able to diagnose an active coronavirus infection. Positive results from an antigen test are considered to be highly accurate, but the test does not completely rule out the coronavirus infection. To get the most precise readings, you need to acquire a swab test, or RT-PCR test.

Q: What is the best COVID antigen test?

A: Realy COVID-19 Antigen Rapid Home Test Kit. That's where the Realy COVID-19 Antigen Home Test can come in handy. We found it the easiest to use above all other tests. With this test, there's no hassle, complicated steps, extra technology, or hard-to-use components.

Q: How do you take Covid antigen test?

A: Blow your nose. Open the swab wrapping - only touch the swab at the handle, do not touch the soft pad at the tip. Insert the swab into your left nostril until you feel resistance, this is usually about 2cm to 4cm. Roll the swab 5 times inside the nostril. Using the same swab, repeat this process in your right nostril.

Q: Can you test Covid from saliva?

A: A positive PCR or other molecular amplification test result means a person currently has COVID-19. Molecular tests are performed by collecting a nasal swab or a saliva sample. Nasal swab: A nasal swab looks like a long Q-tip. It is inserted about two inches into your nose and swirled around for a few seconds.

Q: How reliable are saliva antigen tests?

A: Diagnostic accuracy of both self-tests was assessed with molecular testing as reference. Results: Out of 2819 participants, 6.5% had a positive molecular test. Overall sensitivities were 46.7% (39.3-54.2%) for the saliva Ag-RDT and 68.9% (61.6-75.6%) for the nasal Ag-RDT.

Q: What hormones can be detected in saliva?

A: Published research has substantiated the accuracy of saliva testing in determining the values of specific hormones such as the major estrogens (estradiol, estrone, estriol), progesterone, androgens (dehydroepiandrosterone, testerone, 5a-dihydrotestosterone), cortisol, and melatonin.

Q: Is a rapid antigen test the same as a home test?

A: Molecular tests, such as polymerase chain reaction (PCR) and other nucleic acid amplification tests (NAATs) tests, which detect genetic material called RNA from the virus. Antigen tests, often referred to as rapid tests or, for some, at-home or self tests, which detect proteins called antigens from the virus.

Q: The test strip is very discolored. What may be the reasons?

A: The reason for a clearly visible discoloration of the test strip is that too many drops has been dispensed from the extraction tube into the specimen well of test card. The indicator strip can only hold a limited amount of liquid. If the control line (C) does not appear or the test strip is very discolored, please retest by using a new test card according to the instructions for use.

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