İnkılap Mah. Küçüksu Cad. No:109, D:19, 34764 ÜMRANIYE / ISTANBUL / TURKIYE
Foaming Test - Covid-19 Screening Test Kit
What is it?
It is a special urine test that is used in pre-diagnosis and clinical follow-up of diseases progressing with excretion of substances, which should not be present normally in urine, mainly COVID-19, is performed by foaming of urine and therefore defined as "foaming test".
Foaming Test - Covid-19 Screening Test Kit ile
What to Look for
Viruses are infectious agents containing their own genetic structures, protein structures and amino acid structures, which are the sub-sequences of these protein structures, and that are only visible with a microscope. The virus causing Covid-19 disease (Sars Cov-2) is also a RNA virus having its own genetic structure, protein and amino acid structures.
Sars Cov-2 reproduces rapidly as soon as it enters the body. In the meantime, it begins to create some metabolic and chemical changes start to occur in the body before clinical symptoms and lung findings are developed. Some of these changes can be followed by blood, urine and tests.
As the virus load in the body increases, the viral structures, metabolites of the viral structures and some substances formed arising from the problems indirectly caused by the virus also begin to be excreted from the body by urine. The excretion rate is directly related to the infectivity of the virus, the number of the virus infecting the individual, the strength of the individual's immune system, the individual's metabolism and his/her other diseases.
The reactant (MSK) available in the foaming test and specifically prepared in the laboratory reacts with both some substances belonging to the virus and metabolites of these substances and with some substances which are caused by the virus and should not be normally present in the urine, and the sample in the test tube will foam. The foaming rate increases in direct proportion to the viral load in the body. Less foam will be formed in people with lower viral load, and more foam will be formed in people with higher viral load.
As a result of the date obtained from laboratory studies in patients diagnosed with COVID-19 and in healthy individuals who have not had COVID-19, a color scale has been formed on the test tube. Foaming test results will be evaluated based on this color scale.
With Foaming Test;
Infected people are determined in a short time like 15 seconds, and their treatments can be started quickly and rapid recovery is provided.
Easy to apply
There is no need to draw blood or take throat and nose swabs as in PCR tests.
Certified by the Ministry of Health
Foaming Test - Covid-19 Screening Test Kit is registered with the product tracking system and has CE declaration and ISO certificates.
Economic test
Foaming Test - Covid-19 Screening Test Kit cost is lower than PCR tests, it is easy to apply, and results are obtained quickly.
Foaming Test - Covid-19 Screening Test Kit
How To Use?
Urine Sample Collection for the Use of the COVID-19 Screening Test Kit and Using the Test:
* Dikkat: Since substances and metabolites of SARS COV-2 will be excreted from the urine depending on the metabolism of the individual and the severity of the infection, such substances may not be present in the urine at the same concentration every hour of the day particularly in non-severe cases. Therefore the most optimum sample for the individuals who will undergo the test will be the urine that has been kept in their bladder for at least 1 hour. This could be, for example, the 2nd urine sample to be given after getting up in the morning. For the individuals who are physically engaged in heavy work, the urine sample should be taken after at least 6 hours of rest. The urine sample taken should not be the first urine during the rest period. When pregnant women are tested, the presence of substances, which are excreted in the urine and should not be normally present, must be discarded. Urine samples of the individuals with the catheter attached should be taken from the first unit that comes after the bag and tubing of the catheter has been drained. In the samples taken from the urinary catheter, care should be taken not to take accidentally the sample through the balloon section of the catheter containing water. If the change of the catheter is not in question, the urine in the existing catheter bag should be thoroughly mixed, and the sample should be taken accordingly. The first urine following a sexual intercourse should not be used for testing.
** Dikkat: With the vacuum effect in tube, the sample in the urine container begins to fill into the test tube. It must be checked whether the urine sample level is exactly at the black indication line on the tube. The vacuum in the tube can rarely cause the amount of urine to be below or above the black line due to the altitude where the test is used. In such a case, the test tube should be placed in an upright position with the cap at the bottom. If the urine level in the test tube is above the black line, then an amount of urine must be drawn with the syringe in the Foaming Test box until the urine level in the test tube goes down the black line. If the urine level in the test tube is below the black line, then an amount of urine must be taken from the urine container and added into the test tube by using the syringe until the amount of urine in the test tube goes up the black line. The recessed plastic section on the cap of the test tube is the area where the syringe needle is inserted. Following this process, testing can continue.
Product Introduction
How To Use Foaming Test?
Foaming Test - Covid-19 Screening Test Kit
Results Evaluation Chart
Red Zone: It is a "critical" clinical picture indicating intense viral load (and/or substances that should not be present in the urine) in the urine. These individuals must immediately apply to a fully-equipped healthcare facility. Even if these people do not have any symptoms, they must be evaluated in detail in terms of both Covid-19 and urinary system disorders.
Orange Zone: It is an "adverse" clinical picture indicating increased viral load (and/or substances that should not be present in the urine) in the urine. These individuals must immediately apply to a fully-equipped healthcare facility, and they also must be evaluated in terms of both Covid-19 and urinary system disorders.
Yellow Zone: It is a "suspected" clinical picture indicating little viral load (and/or substances that should not be present in the urine) in the urine. These individuals are required to be followed.
Green Zone: There is no viral load in the urine. It is the "favorable" clinical picture. The green zone in the foaming test result of the patients diagnosed with Covid-19 positive and started treatment is interpreted as the treatment process has been successful and the virus load in the body eliminated.
View User Manuel
It Removes Covid-19 Suspicion within 15 Seconds and Helps to Reduce Public Health Risks.
Foaming Test - Covid-19 Screening Test Kit
In What Situations Can It Be Used?
It helps to identify people who have some clinical findings but it is not yet clear whether they have COVID-19 or not, in the incubation period and determine their clinical condition.
It helps to follow-up the clinical condition and prognosis of people diagnosed with COVID-19. It helps to make daily clinical follow-up of people whose prognosis worsens when it is good, or those who get better when their prognosis is bad.
It helps people who are suspected of COVID-19, who are in the follow-up process, in the quarantine process, who have completed their treatment and who are in the process of follow-up at home, learn their clinical situations in a practical way and share them with the doctor who follows them.
It helps people who are anxious about COVID-19, who have to enter a suspicious environment and who are uncomfortable with this situation, to control themselves and thus to apply to healthcare facilities quickly if necessary according to the test result.
It helps to distinguish people who have similar complaints but who do not have COVID-19 but suffer from another infection.
In case of urinary tract infection other than COVID-19, it helps people to control themselves in early stage.
It facilitates the work of healthcare professionals in the pre-diagnosis, final diagnosis and clinical follow-up processes they established on patients.
Foaming Test - Covid-19 Screening Test Kit
Certificates and Documents
Foaming Test - Covid-19 Screening Test Kit
Frequently Asked Questions
Foaming test is a COVID-19 rapid screening test kit that is performed with a urine sample in 15 seconds.
The reactant available in the foaming test and specifically prepared in the laboratory reacts with both substances present on the virus and remnants belonging to the virus and with such substances which are caused by the virus and should not be normally present in the urine. This reactant yields results by foaming with urine sample in the test tube.
Foaming test can be used to evaluate the course of the disease and treatment in adults, children, the elderly, infants, patients, pregnant women and COVID-19 patients.
It helps to identify individuals who have some clinical findings but it is not yet clear whether they have COVID-19 or not, in the incubation period and determine their clinical condition. It helps to follow-up the clinical condition and course (prognosis) of individuals diagnosed with COVID-19. It helps to make daily clinical follow-up of individuals whose prognosis worsens when it is good, or those who get better when their prognosis is bad. It helps to distinguish people who have similar complaints but who do not have COVID-19. It helps individuals who have COVID-19 negative, who are in the follow-up process, in the quarantine process, who have completed their treatment and who are in the process of follow-up at home, learn their clinical situations in a practical way and share them with the doctor who follows them so that the doctor can make a decision quickly about the treatment process. It helps individuals who are anxious about COVID-19, who have to enter a suspicious environment and who are uncomfortable with this situation, to control themselves and thus to apply to healthcare facilities quickly if necessary according to the test result. It helps individuals with certain substances in their urine that should not normally exist, other than COVID-19, to control themselves and consult a healthcare facility early. It facilitates the work of healthcare professionals in the pre-diagnosis, final diagnosis and clinical follow-up processes they established on patients.
It is certified by the Ministry of Health. It is a practical test that can be performed in any environment. The result can be obtained within 15 seconds, and it helps to alleviate the concerns of healthy individuals about Covid-19. Clinical follow-up of individuals with the disease can be performed comfortably and quickly, it can be detected that an individual has an abnormal condition other than Covid-19, and thus early diagnosis and treatment can be provided.
Foaming is directly proportional to the virus load in the body. Less foam will be formed those with lower viral load, and more foam will be formed those with higher viral load. As a result of laboratory studies conducted between patients diagnosed with COVID-19 and healthy people, a color scale has been created. The level of the foam also indicates the level of the disease.
It is very easy to use the Foaming Test, which will be provided by the healthcare facility you have applied to. It can be performed easily without any help by following the instructions in the user manual.
Based on the technical difficulties such as the kits currently used in the diagnosis of COVID-19 being newly developed and not tested with sufficient number of clinical samples, UTS (Product Tracking System) records and imports of these diagnostic kits are being subjected to the pre-authorization of Turkish Medicines and Medical Devices Agency in order to protect public health and prevent the spread of the COVID-19 Pandemic due to the possibility of having a higher margin of error than the specified security range. In this context, the authority to determine whether COVID-19 diagnostic kits are effective in the diagnosis of the disease has been given to the General Directorate of Public Health by the Turkish Medicines and Medical Devices Agency. Studies have been carried out on clinical samples of patients with suspected COVID-19 using the foaming test kit. As a result of the assessment carried out by the General Directorate of Public Health, it is concluded that it is acceptable to use the Foaming test kit as a screening test to evaluate the clinical course in the diagnosis of COVID-19.
The Foaming Test kit is a diagnostic kit. Its working principle is reaction with urinary components. The viral load undoubtedly reaches the kidneys after entering the body. Thus, it is possible to detect the infection within the first 3 days after the virus is infected.
Foam test kit is a diagnostic kit that has emerged as a result of many scientific studies. Quantitative data indicates the burden of the virus on the body. Ease of use and duration of test results are unlike other tests. Test kit reactant is again based on know-how and cannot be easily copied. Patent applications have also been made for the method of yielding results by foaming from urine.
Scientific Articles
The Prevalence and Effect of Acute Renal Failure on COVID-19: Systematic Review and Meta-Analysis
Objective: It is to assess the prevalence of abnormal urine analysis and kidney dysfunction in COVID-19 patients and to determine the association of acute kidney injury (AKI) with the severity and prognosis of COVID-19 patients. A meta-analysis of eligible studies that reported the prevalence of abnormal urine analysis and kidney dysfunction in COVID-19 was performed. The incidences of AKI were compared between severe versus non-severe patients and survivors versus non-survivors. A total of 24 studies involving 4963 confirmed COVID-19 patients were included. The proportions of patients with elevation of sCr and BUN levels were 9.6% and 13.7%, respectively. Out of all patients, 57.2% had proteinuria, 38.8% had proteinuria +, and 10.6% had proteinuria ++ or +++. The overall incidence of AKI in all COVID-19 patients was 4.5%, while the incidence of AKI was 1.3%, 2.8%, and 36.4% in mild or moderate cases, severe cases, and critical cases, respectively. Meanwhile, the incidence of AKI was 52.9%, 0.7% in non-survivors and survivors, respectively. Continuous renal replacement therapy (CRRT) was required in 5.6% severe patients, 0.1% non-severe patients and 15.6% non-survivors and 0.4% survivors, respectively. The incidence of abnormal urine analysis and kidney dysfunction in COVID-19 was high and AKI is closely associated with the severity and prognosis of COVID-19 patients. Therefore, it is important to increase awareness of kidney dysfunction in COVID-19 patients.
Source
COVID-19-Associated Nephritis: Early Warning for Disease Severity and Complications?
We recommend that patients with COVID-19 who have nephritis be carefully monitored for the following conditions: pulmonary interstitial oedema, due to severe fluid overload similar to nephrotic syndrome; immune incompetence, due to renal loss of immunoglobulins; circulatory insufficiency, due to hypalbuminaemia; poor drug response because of impaired plasma protein binding; and thromboembolic events due to antithrombin deficiency. The respiratory tract is the gateway for SARS-CoV-2 infection. We postulate that COVID-19-associated nephritis, which can be easily screened for through a simple and inexpensive urine sample analysis, might help predict complications. This algorithm awaits further validation as a prediction tool. We have initiated a multicentre observational study (NCT04347824) in Germany to confirm our findings. If validated, we believe this tool could allow early anticipation of later need for ICU admission, improved allocation of patients for special therapies (e.g., in clinical trials), and initiation of preventive strategies focused on capillary leak syndrome, including treatment that could save lives. The same screening methods could be used for the risk evaluation of outpatients.
Source
The Urine Foaming Test in COVID-19 as a Useful Tool in Diagnosis, Prognosis and Follow-up: Preliminary Clinical Study Results
In this study, we present the preliminary results of the first clinical study with a newly developed urine foaming test (UFT). which has predictive and prognostic value in the diagnosis of COVID19, predicting prognosis, and evaluating response to treatment. In a tertiary education and research hospital in Istanbul, 4 groups were formed by collecting urine samples from 3 patient groups whose informed consent was obtained. Group A: outpatients with suspected COVID-19 and followed-up Group B: inpatients for follow-up and treatment Group C: patients treated in intensive care unit (ICU) Group D: 30 healthy volunteers were included as the control group. Urine samples taken into sterile urine collection containers from all groups were delivered to the laboratory within one hour. 2.5 ml urine sample was added to the test tube and shaken for 15 seconds, and the level of foam formed was visually evaluated according to the color scale. Other data of the patients were obtained from the hospital information management system and the physician caring for the patient. The clinical status (mild, moderate, severe), PCR test results, computed tomography (CT), if any, biochemical tests, and UFT results were compared, and the level of statistical significance was expressed as p< 0.05. Performance characteristics, such as sensitivity, specificity, positive and negative predictive value of the UFT, were statistically calculated according to the PCR result and/or CT. Results: A statistically significant difference was observed between UFT distributions of the control, outpatient, inpatient and ICU patients (p=0.0001). The results of UFT orange and red in inpatients and ICU patients were statistically significantly higher than in the control and outpatient groups. The diagnostic accuracy of UFT was determined in all group, the pooled sensitivity was 92% (95% CI: 87–95%) and specificity was 89% (95%CI: 80–98%).
Conclusion: Our preliminary results suggest that the UFT is useful, particularly in predicting the clinical severity of COVID-19. The urine foaming test could be recommended as a point of care test, rapid, simple and non-invasive method in the prognosis and treatment follow-up of COVID-19.
The urine foaming test in COVID-19 as a useful tool in diagnosis, prognosis and follow-up: Preliminary results
Objective: We aimed to develop a simple, rapid urine test based on the level of foaming that occurs in the urine sample due to the excretion of peptide structures containing amino acids specific to the antigenic structure of COVID-19. In this study, we present the preliminary results of the first clinical study with a newly developed urine foaming test (UFT).
Methods: This study was conducted in a tertiary hospital in Istanbul. After obtaining the approval of the ethics committee, urine samples were taken from three groups of patients whose informed consent was obtained. The groups were created according to the COVID-19 Diagnostic Guide of Ministry of Health: A: outpatients with suspected COVID-19, B: inpatients for follow-up and treatment, C: patients treated in intensive care unit (ICU). Also, 30 healthy volunteers were included as the control group D. Urine samples taken from all groups were delivered to the laboratory. 2.5 ml urine sample was added to the test tube and shaken for 15 seconds and the level of foam formed was visually evaluated according to the color scale. Other data of the patients were obtained from the hospital information management system and the physician caring for the patient. The clinical status, PCR test results, computed tomography (CT), if any, laboratory tests, and UFT results were compared and the level of statistical significance was expressed as p≤0.05 in the 95% confidence intervals (CI). Performance characteristics, such as sensitivity, specificity, positive and negative predictive value of the UFT, were statistically calculated according to the RT-PCR result and/or CT.
Results: A statistically significant difference was observed between UFT distributions of the control, outpatient, inpatient and ICU patients (p=0.0001). The results of UFT orange and red in inpatients and ICU patients were statistically significantly higher than in the control and outpatient groups. The diagnostic accuracy of UFT was detected in all group, the pooled sensitivity was 92% (95% CI: 87-95%) and specificity was 89% (95% CI: 80-98%).
Conclusion: Our preliminary results suggest that the UFT is useful, particularly in predicting the clinical severity of COVID-19. The UFT could be recommended as a point of care test, rapid and non-invasive method in the diagnosis and follow-up of COVID-19.
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