Saliva Self Test

Why choose REALY?

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.

Quality Assurance

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.

Strict Quality Control

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

Sales to The World

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 Saliva Self Test?

Saliva testing or Salivaomics is a diagnostic technique that involves laboratory analysis of saliva to identify markers of endocrine, immunologic, inflammatory, infectious, and other types of conditions. Saliva is a useful biological fluid for assaying steroid hormones such as cortisol, genetic material like RNA, proteins such as enzymes and antibodies, and a variety of other substances, including natural metabolites, including saliva nitrite, a biomarker for nitric oxide status.

Principle of Saliva Self Test

The COVID-19 Ag Rapid Saliva Test Device uses double antibody sandwich immunoassay. The NC membrane pre-immobilized with monoclonal antibodies against SARS-CoV-2 antigen and anti-mouse polyclonal antibodies, and the colloidal-gold conjugated with monoclonal antibodies specific to SARS-CoV-2 antigen. If SARS-CoV-2 antigen is present in the sample, a complex is formed between the anti-SARS-CoV-2 conjugate and the antigen will be caught by the specific anti-SARS-CoV-2 monoclonal antibodies coated in the test region (T). Results appear in 10 to 20 minutes in the form of a red line that develops on the strip. Whether the sample contains the SARS-CoV-2 antigen or not, the solution continues to migrate to encounter another reagent (an antimouse IgG antibody) that binds the remaining conjugates, thereby producing a red line on the control region (C).

Benefits of Saliva Self Test

Easy to Collect

This test only requires collection of saliva in a sterile container, as opposed to deep nasal swab (i.e., the nasopharyngeal (NP) swab), which can be uncomfortable for the patient and requires trained personnel wearing special personal protective equipment (PPE) to collect.

Fewer Collection Supplies Required

Saliva can be collected in sterile containers that are widely available, cheap and do not require special preservatives or containers. In these times, during which supplies are scarce, this is very desirable.

Human Monkeypox Virus (MPV) IgG/IgM Antibody Rapid Test Device

Fewer Steps in Testing

Testing for nucleic acids by molecular amplification (i.e., PCR) generally requires the viral RNA to be removed from the specimen and purified. The Saliva test uses a simple procedure that does not require instrumentation to open the virus and remove the viral RNA.

Human Monkeypox Virus (MPV) Real Time PCR Assay Kit

Instrument Accessibility

The Saliva test can be performed on several types of instruments found in specialized clinical molecular laboratories, potentially allowing those laboratories to start testing without acquiring additional, expensive instruments.

Applications of Saliva Self Test

Use of Saliva in Screening Symptomatic Individuals

Although sensitivity will differ depending on the different sample collection technique and considering the limitations of this sample type, saliva may be used as an alternative for RT-PCR tests.

Use of Saliva in Screening Asymptomatic Individuals

Given the ease of use and the non-invasive nature of saliva collection, it can have great benefits if used for selfcollection and repeat testing of individuals in given settings. Saliva specimen can therefore be considered as an option for the detection of SARS-CoV-2 in asymptomatic individuals who are required to self-test frequently for occupational or other reasons.

Use of Saliva in Testing Childre

With saliva collection being easy and non-invasive, it should offer a feasible approach for widespread testing of SARS-CoV-2 in children.

Components of Saliva Self Test Kit

1. Test Device
2. Buffer & Filter Cap
3. Sample Collection Tube & Cap & Sample Collection Funnel
4. Instruction Manual & Quick Guide

Operation Steps of Saliva Self Test

01/

Wash your hands before the test.

02/

Remove the test from the packaging.

03/

Take the saliva collector out of the base.

04/

Remove the protector from the tip.

05/

Deeply cough 4 times into your mouth.

06/

Rub the collector tip against your tongue and the inside of both cheeks.

07/

Place the collector tip under or to the side of your tongue.

08/

Wait for 2 minutes with the collector tip inside your mouth, ensuring it stays at an upward angle.

09/

After 2 minutes, remove the collector from your mouth and push the tip down firmly into the base.

10/

Align the top of the base to the middle of the supporting ring.

11/

Wait 15 minutes, then check your results. Results will be invalid after 30 minutes.

12/

Place the kit into a plastic bag and dispose of using your household waste or rubbish bin.

Read Test Results

Positive Result
One coloured line should be in the control region (C) and another coloured line should be in the Test region (T).

*Note: The intensity of the colour in the test line region (T) will vary based on the amount of SARS-(CoV-2 antigen present in the sample. Any shade of colour in the test region (T) should be considered a positive result.

Negative Result
No apparent coloured line appears in the test line region (T) You are unlikely to have COVID-19. However, it is possible for this test to give a negative result that is incorrect (a false negative) in some people with COVID-19. This means you could possibly still have COVID-19 even though the test is negative. If you experience symptoms such as headaches, migraines, fever, loss of sense of smell or taste, contact the nearest medical facility according to the rules of our local authority.

Invalid Result
Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test or contact our COVID-19 test centre.

Precautions of Saliva Self Test Kit

Each device is for single use only and cannot be reused.
DO NOT eat, drink, smoke, brush teeth, or chew gum for 30 minutes before collecting saliva. DO NOT swallow.
Keep out of the reach of children. Children 2-15 years of age should be tested by an adult. Children aged 15 and over should be assisted by an adult. Do not use this test on children under 2 years of age.
Use a separate test for each person.
This test is for human use only.
Read the Package Insert prior to use.
Do not use if pouch is damaged or open.

Storage and Stability

It should be stored at 2℃~ 30℃, be kept dry and away from sunlight.
The shelf life is 18 months.
For per test, it should be used within 30 minutes after unsealing.
Production date and expiration date are shown in the package label.
Samples should be used as soon as possible after collection and should not be stored for a long time at room temperature. If the sample can not be detected in time, the sample can be stored for 48 hours at 2 ℃ - 8 ℃. Long term storage should be frozen at - 20 ℃, avoid repeated freezing and thawing.

Limitation of Saliva Self Test

Tests are for diagnostic purposes if you believe you may be infectious please contact your GP for additional assistance.

Test Card performance depends on the amount of virus (antigen) in the sample and may or may not correlate with viral culture results performed on the same sample.

Failure to follow the Test Procedure may adversely affect test performance and/or invalidate the test result.

Reading results in less than 10 minutes may lead a false negative result whilst reading results after more than 15 minutes may lead to a false positive result.

If the sample volume is not enough, the test cannot be carried out successfully.

Our certificate

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

Common Problems of Saliva Self Test

Q: What is saliva self testing?

A: 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.

Q: What does a saliva test tell you?

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 COVID tests accurate?

A: First and foremost, 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: Is saliva or nasal COVID home test kit better?

A: Participants indicated that taking a sample was easier for the self-performed saliva Ag-RDT than for the self-performed nasal Ag-RDT, with a larger proportion of participants indicating it was easy or very easy for the saliva Ag-RDT than for the nasal Ag-RDT .

Q: What diseases can be detected in a saliva test?

A: With new and highly sensitive technologies, the lower level of analytes in saliva is no longer a limitation. Almost anything that can be measured in blood can also be measured in saliva. Saliva has been reliably used to detect HIV-1 and -2, and viral hepatitis A, B and C. It can also be used to monitor a variety of drugs including marijuana, cocaine and alcohol.

Q: Can TB be detected in saliva?

A: The semiquantitative Xpert Ultra grade was systematically higher in sputum than in a paired saliva sample from the same patient. In conclusion, molecular testing of saliva for active TB diagnosis was feasible and almost as sensitive as molecular testing of sputum in a high TB burden setting.

Q: How long is a saliva sample good for?

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 for hormones accurate?

A: Saliva testing accurately measures the hormones that are “bioavailable” to organs and tissues. If these active levels are too high or too low, it may be the cause behind health issues such as irregular periods, weight gain, fatigue, hot flashes, night sweats and many others.

Q: Can Covid be tested with saliva?

A: They can be used whether or not you have symptoms. 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.

Q: Is nasal test better than saliva?

A: Another recent preprintopens in a new tab or window from researchers in South Africa also suggested, based on 67 Omicron and Delta cases, that positive saliva tests were more reliable than positive nasal mid-turbinate swabs for Omicron.

Q: How effective is saliva antigen test?

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: Which at home COVID test uses saliva?

A: How does the P23 At-Home Covid-19 Test Collection Kit work? The P23 At-Home Covid-19 Test Collection Kit provides you with a way to get tested for the virus from the comfort and security of your own home by providing a saliva specimen. No trip to the doctor’s office or other healthcare provider is required to get COVID-19 testing.

Q: What makes a saliva test positive?

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.

Q: Is saliva or blood test more accurate?

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: Why is saliva diagnostic important?

A: Saliva diagnosis is a method of diagnosing diseases by detecting biomarkers related to specific organ diseases in saliva. It is considered to be a very promising way, which can provide early and accurate diagnosis, improve prognosis, and conduct good monitoring after treatment.

Q: What infections can be found in saliva?

A: Here are a few other illnesses which can work their way from your saliva into your nose, throat and lungs: Rhinovirus (colds).
Flu virus.
Epstein-Barr virus (mononucleosis, or mono).
Type 1 herpes (cold sores).
Strep bacteria.
Hepatitis B and hepatitis C.
Cytomegalovirus (a risk during fetal development).

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.

Q: How do you collect saliva for Covid test?

A: 1 Spit until the amount of saliva (not bubbles) reaches the fill line. 2 Close lid tightly by pushing down hard on the funnel lid until you hear a loud click. 3 Unscrew the funnel from the tube. 4 Use small cap to close tube tightly.

Q: Is COVID saliva test not accurate?

A: 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. The benefit of saliva testing lies in the ease of collection. It is quick, painless and able to be self-collected by the person, which means samples can be easily collected on a daily basis.

Q: Is there saliva antigen test?

A: As they are a saliva-based test, many people find them easier to use than the antigen swab tests. The COVID-19 Antigen Saliva Test Kit is used for the qualitative detection of novel coronavirus (COVID-19) antigen in saliva sample, only for in vitro diagnostic use.

Q: What is the reliability of saliva testing?

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.

Q: Does saliva test count as PCR?

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.

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