COVID-19 Testing

Symptoms of COVID-19

Watch for symptoms:

Reported illnesses have ranged from mild symptoms to severe illness and death for confirmed coronavirus disease 2019 (COVID-19) cases.

The following symptoms may appear 2-14 days after exposure.*

  • Fever

  • Cough

  • Shortness of breath

*This is based on what has been seen previously as the incubation period of MERS-CoV viruses.

If you develop emergency warning signs for COVID-19 get medical attention immediately. Emergency warning signs include*:

  • Difficulty breathing or shortness of breath

  • Persistent pain or pressure in the chest

  • New confusion or inability to arouse

  • Bluish lips or face

*This list is not all inclusive. Please consult your medical provider for any other symptoms that are severe or concerning.

Older Adults & COVID-19

Older adults 65 years and older are at higher risk for severe illness.

Are You at Higher Risk for Severe Illness?
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People who are at higher risk from severe illness

Some people may be at higher risk of getting very sick from this illness. This includes:

  • Older adults

  • People who have serious underlying medical conditions like:

  • Heart disease

  • Diabetes

  • Lung disease

Protect Yourself from COVID-19

Take steps to help prevent getting sick. Everyone has a role to play.

How to Protect Yourself

Older adults and people who have severe underlying chronic medical conditions like heart or lung disease or diabetes seem to be at higher risk for developing more serious complications from COVID-19 illness. Please consult with your health care provider about additional steps you may be able to take to protect yourself.

Know How it Spreads

  • There is currently no vaccine to prevent coronavirus disease 2019 (COVID-19).

  • The best way to prevent illness is to avoid being exposed to this virus.

  • The virus is thought to spread mainly from person-to-person.

  • Between people who are in close contact with one another (within about 6 feet).

  • Through respiratory droplets produced when an infected person coughs or sneezes.

  • These droplets can land in the mouths or noses of people who are nearby or possibly be inhaled into the lungs.

Take steps to protect yourself

Clean your hands often

  • Wash your hands often with soap and water for at least 20 seconds especially after you have been in a public place, or after blowing your nose, coughing, or sneezing.

  • If soap and water are not readily available, use a hand sanitizer that contains at least 60% alcohol. Cover all surfaces of your hands and rub them together until they feel dry.

  • Avoid touching your eyes, nose, and mouth with unwashed hands.

Avoid close contact

Take steps to protect others

Stay home if you’re sick

Cover coughs and sneezes

  • Cover your mouth and nose with a tissue when you cough or sneeze or use the inside of your elbow.

  • Throw used tissues in the trash.

  • Immediately wash your hands with soap and water for at least 20 seconds. If soap and water are not readily available, clean your hands with a hand sanitizer that contains at least 60% alcohol.

Wear a facemask if you are sick

  • If you are sick: You should wear a facemask when you are around other people (e.g., sharing a room or vehicle) and before you enter a healthcare provider’s office. If you are not able to wear a facemask (for example, because it causes trouble breathing), then you should do your best to cover your coughs and sneezes, and people who are caring for you should wear a facemask if they enter your room. Learn what to do if you are sick.

  • If you are NOT sick: You do not need to wear a facemask unless you are caring for someone who is sick (and they are not able to wear a facemask). Facemasks may be in short supply and they should be saved for caregivers.

Clean and disinfect

  • Clean AND disinfect frequently touched surfaces daily. This includes tables, doorknobs, light switches, countertops, handles, desks, phones, keyboards, toilets, faucets, and sinks.

  • If surfaces are dirty, clean them: Use detergent or soap and water prior to disinfection.

To disinfect:

Most common EPA-registered household disinfectants will work. Use disinfectants appropriate for the surface.

Options include:

Diluting your household bleach.
To make a bleach solution, mix:

5 tablespoons (1/3rd cup) bleach per gallon of water
OR
4 teaspoons bleach per quart of water

Follow manufacturer’s instructions for application and proper ventilation. Check to ensure the product is not past its expiration date. Never mix household bleach with ammonia or any other cleanser. Unexpired household bleach will be effective against coronaviruses when properly diluted.

Alcohol solutions.
Ensure solution has at least 70% alcohol.

Other common EPA-registered household disinfectants.
Products with EPA-approved emerging viral pathogens  [7 pages] claims are expected to be effective against COVID-19 based on data for harder to kill viruses. Follow the manufacturer’s instructions for all cleaning and disinfection products (e.g., concentration, application method and contact time, etc.).

THIS DOCUMENT MAY CONTAIN CONFIDENTIAL OR PROPRIETARY INFORMATION, INCLUDING PATIENT HEALTH INFORMATION THAT IS PROTECTED UNDER HIPAA AND OTHER STATE AND FEDERAL CONFIDENTIALITY LAWS. PLEASE DELIVER IMMEDIATELY ONLY TO THE INTENDED RECIPIENT. IF THIS TRANSMISSION WAS RECEIVED IN ERROR, PLEASE CONTACT THE SENDER IMMEDIATELY AND DO NOT DISTRIBUTE THE INFORMATION TO ANY OTHER PERSON.

POINT OF CARE RAPID SCREEN TEST— $80

(See Following Pages)
FULL CLIA & CAP ACCREDITED PATHOLOGY LAB TEST — $130

We provide a Kit with a pre-paid FedEx Standard Overnight Return Label. Specimen is taken and overnighted to our lab for PCR (Polymerase Chain Reaction) Testing. This is done using DNA sequencing on ThermoFisher QuantoStudio 12 Analyzers. Where accuracy is paramount. You are free to use either testing method or both. The Rapid screen can be used and then a specimen sent to our pathology lab for confirmation. We will then Report the Results using an Online Portal or Fax.

$80 per Point of Care Rapid Screen COVID-19 Test Kit
Antibodies will be secreted after virus invasion. Immunoglobulin M (Igm) comes out first, acting as the early sign of infection. Immunoglobulin G (IgG) comes out later, arising a more specific and stronger reaction against the virus.
Results Interpretation

(INTERPRETATION OF RESULTS)

IgG POSITIVE:• Two colored lines appear. One colored line should always appear in the control line region (C) and another line should be in the IgG line region.

IgM POSITIVE:* Two colored lines appear. One colored line should always appear in the control line region (C) and another line should be in the IgM line region.

IgG and IgM POSITIVE:' Three colored lines appear. One colored line should always appear in the control line region (C) and two test lines should be in the IgG line region and IgM line region.

*NOTE: The intensity of the color in the test line regions may vary depending on the concentration of 2019-nCoV antibodies present in the specimen. Therefore, any shade of color in the test line region should be considered positive.

NEGATIVE: One colored line appears in the control line region (C). No line appears in the IgG region and IgM region.

INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control fine failure. Review the procedure and repeat the test with a new test. If the problem persists, discontinue using the test kit immediately and contact your local distributor.

Interpretation

IgM (+) / IgG (-) It may be an acute infection. This is during the time the patient start to have fever. Recommendation for quarantine.

Reexamination is recommended one week later

IgM (+) / IgG (+) It may be an acute infection. Check the severity of the symptoms and decide if you need to send the patient to the Hospital.

Reexamination is recommended one week later

IgM (-) / IgG (+) IgG maybe previous infection. Further observation.

IgM (-) / IgG (-) Negative.

Price of Test:
$80.00

2019-nCoV IgG/IgM
Rapid Test Cassette
Single use kit
(Finger stick Whole Blood)
Package Insert

REF COVID-M

English

A rapid test for the qualitative detection of IgG and 104 antibodies to 2019-nCoV in human Finger stick Whole Blood specimens. For professional in vitro diagnostic use only.

[INTENDED USE]

The 2019-nCoV IgG/IgM Rapid Test Cassette is a lateral flow chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies to 2019-nCoV in human Finger stick Whole Blood specimen.

[SUMMARY]

Early January 2020, a novel coronavirus (2019-nCoV) was identified as the infectious agent causing an outbreak of viral pneumonia in Wuhan, China, where the first cases had their symptom onset in December 2019.'

Coronaviruses are enveloped RNA viruses that are distributed broadly among humans, other mammals, and birds and that cause respiratory, enteric, hepatic, and neurologic diseases.' Six coronavirus species are known to cause human disease.' Four viruses — 229E. 0C43, NL63, and HKU1 — are prevalent and typically cause common cold symptoms in immunocompetent individuals.' The two other strains — severe acute respiratory syndrome coronavirus (SARS-COV) and Middle East respiratory syndrome coronavirus (MERS-COV) — are zoonotic in origin and have been linked to sometimes fatal illness.'

Coronaviruses are zoonotic, meaning they are transmitted between animals and people.

Common signs of infection include respiratory symptoms, fever, cough. shortness of breath and breathing difficulties. In more severe cases. infection can cause pneumonia, severe acute respiratory syndrome, kidney failure and even death.'

Standard recommendations to prevent infection spread include regular hand washing. covering mouth and nose when coughing and sneezing, thoroughly cooking meat and eggs. Avoid close contact with anyone showing symptoms of respiratory illness such as coughing and sneezing.'

[PRINCIPLE]

The 2019-nCoV IgG/IgM Rapid Test Cassette (Finger stick Whole Blood) is a qualitative membrane-based immunoassay for the detection of IgG and IgM antibodies to 2019-nCoV in Finger stick Whole Blood specimen. This test consists of two components, an IgG component and an IgM component. In the IgG component, anti-human IgG is coated in IgG test line region. During testing, the specimen reacts with 2019-nCoV antigen-coated particles in the test cassette. The mixture then migrates upward on the membrane chromatographically by capillary action and reacts with the anti-human IgG in IgG test line region, if the specimen contains IgG antibodies to 2019-nCoV. A colored line will appear in IgG test line region as a result of this. Similarly, anti-human IgM is coated in IgM test line region and if specimen contains IgM antibodies to 2019-nCoV, the conjugate-specimen complex reacts with anti-human IgM. A colored line appears in IgM test line region as a result.

Therefore, if the specimen contains 2019-nCoV IgG antibodies, a colored line will appear in IgG test line region. if the specimen contains 2019-nCoV IgM antibodies, a colored line will appear in IgM test line region. If the specimen does not contain 2019-nCoV antibodies, no colored line will appear in either of the test line regions, indicating a negative result. To serve as a procedural control, a colored line will always appear in the control line region, indicating that the proper volume of specimen has been added and membrane wicking has occurred

(REAGENTS]

The test contains anti-human IgM and anti-human IgG as the capture reagent, 2019-nCoV antigen as the detection reagent. A goat anti-mouse IgG is employed in the control line system.

[INTERPRETATION OF RESULTS]

IgG POSITIVE:* Two colored lines appear. One colored line should always appear in the control line region (C) and another line should be in the IgG line region.

IgM POSITIVE:* Two colored lines appear. One colored line should always appear in the control line region (C) and another line should be in the IgM line region.

IgG and IgM POSITIVE:* Three colored lines appear. One colored line should always appear in the control line region (C) and two test lines should be in the IgG line region and IgM line region.

*NOTE: The intensity of the color in the test line regions may vary depending on the concentration of 2019-nCoV antibodies present in the specimen. Therefore, any shade of color in the test line region should be considered positive.

NEGATIVE: One colored Tine appears In the control Ilne region (C). No line appears in the IgG region and IgM region.

INVALID: Control line falls to appear. 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. If the problem persists, discontinue using the test kit immediately and contact your local distributor.

[QUALITY CONTROL]

Internal procedural controls are included in the test. A colored line appearing in the control region (C) is an internal procedural control. It confirms sufficient specimen volume and correct procedural technique. Control standards are not supplied with this kit; however, it is recommended that positive and negative controls be tested as a good laboratory practice to confirm the test procedure and to verify proper test performance.

[LIMITATIONS]

1. The 2019-nCoV IgG/IgM Rapid Test Cassette (Finger stick Whole Blood) is for in vitro diagnostic use only. This test should be used for detection of IgG and IgM antibody to 2019-nCoV in Finger stick Whole Blood specimens. Neither the quantitative value nor the rate of increase in the concentration of IgG or IgM antibodies to 2019-nCoV can be determined by this qualitative test.

2. The 2019-nCoV IgG/IgM Rapid Test Cassette (Finger stick Whole Blood) will only indicate the presence of IgG and IgM antibodies to 2019-nCoV in the specimen and should not be used as the sole criteria for the diagnosis of 2019-nCoV infections.

3. As with all diagnostic tests, all results must be considered with other clinical information available to the physician.

4. If the test result is negative and clinical symptoms persist, additional follow-up testing using other clinical methods is suggested. A negative result at any time does not preclude the possibility of 2019-nCoV infection.

5. The test will show negative results under the following conditions. The titer of the novel coronavirus antibodies in the sample is lower than the minimum detection limit of the test, or the novel coronavirus antibody has not appeared at the time of sample collection (Asymptomatic stage).

[PERFORMANCE CHARACTERISTICS]

Sensitivity and Specificity

The 2019-nCoV IgG/IgM Rapid Test Cassette (Finger stick Whole Blood) was compared with a leading commercial PCR: the results show that 2019-nCoV IgG/IgM Rapid Test Cassette (Finger stick Whole Blood) has a high sensitivity and specificity.

I G Result

Relative SensitiVty: 100% (95% Cl*: 86.0@0 A)

Relative Specifiety: 98.0% (95% Cl*: 89.4%-99.9%)

Accuracy: 98.6% (95% Cr: 92.3%-99.96%)

*Confidence Interval

[PRECAUTIONS]

1. For professional in vitro diagnostic use only. Do not use after expiration date.

2. Do not eat, drink or smoke in the area where the specimens or kits are handled.

3. Do not use test if pouch is damaged.

4. Handle all specimens as if they contain infectious agents. Observe established precautions against microbiological hazards throughout all procedures and follow the standard procedures for proper disposal of specimens.

5. Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are assayed.

6. 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.

7. The used test should be discarded according to local regulations.

8. Humidity and temperature can adversely affect results.

[STORAGE AND STABILITY]

Store as packaged in the sealed pouch at room temperature or refrigerated (2-30°C). The test is stable through the expiration date printed on the sealed pouch. The test must remain in the sealed pouch until use. DO NOT FREEZE. Do not use beyond the expiration date.

[MATERIALS ]

Materials provided

• Test cassettes • Lancets • Buffers

 • Droppers • Package insert • Alcohol pads • Plastic bags

Materials required but not provided

• Timer

[DIRECTIONS FOR USE]

Allow the test, specimen, buffer and/or controls to reach room temperature (15-30°C) prior to testing.

1. Remove the test cassette from the foil pouch and use it within one hour. Best results will be obtained if the test is performed immediately after opening the foil pouch.

2. Place the cassette on a clean and level surface.

3. Use the provided alcohol swab to clean the fingertip of the middle finger or ring finger as the puncture site.

4. Carefully rotate and pull off the sterile lancet cap. Push the sterile lancet firmly into the fingertip of the middle finger. Do not use the first drop of blood. To increase blood flow, use the thumb and forefinger to gently apply pressure around the puncture site.

5. Hold the dropper vertically, draw the blood to 1cm above the fill line and transfer 1 full drop of whole blood (approximately 20pL) to the specimen well (S), then add 2 drops of buffer (approximately 80 pL), and start the timer. See illustration below.

6. Wait for the colored line(s) to appear. Read results at 10 minutes. Do not interpret the result after 20 minutes.

7. Place the used tests into the plastic ziplock bags provided and seal, discard according to local regulations.

IgM Result

Relative Sensitivity: 85.0% (95%Cr: 62.1%-96.8%)

Relative Specificity: 96.0% (95%Cr: 86.3%-99.5%)

Accuracy: 92.9% (95%C I': 84.1%-97.6%)

*Confidence Interval

Cross-reactivity

The 2019-nCoV IgG/IgM Rapid Test Cassette (Finger stick Whole Blood) has been tested for anti-influenza A virus, anti-influenza B virus, anti-RSV, anti-Adenovirus, HBsAg, anti-Syphilis, anti-H. Pylon, anti-HIV and anti-HCV positive specimens. The results showed no cross-reactivity.

Interfering Substances

The following compounds have been tested using the 2019-nCoV IgG/IgM Rapid Test Cassette (Finger stick Whole Blood) and no interference was observed.

Triglyceride: 50 mg/dL - Ascorbic Acid: 20mg/dL

Hemoglobin: 1000mg/dL - Bilirubin: 60mg/dL

Total cholesterol: 6mmol/L

[BIBLIOGRAPHY]

1. World Health Organization (WHO). WHO Statement Regarding Cluster of Pneumonia Cases in Wuhan, China. Beijing: WHO; 9 Jan 2020. [Accessed 26 Jan 2020].

https://www.who.int/china/news/detail/09-01-2020-who-ctatement-regarning-diister-nf-pnetimonia-caces-in-wt than-china

2. Weiss SR, Leibowitz JL. Coronavirus pathogenesis. Adv Virus Res 2011;81:85-164.PMID:22094080 D01:10.1016/B978-0- 12-385885-6.00009-2

3. Su S, Wong G, Shi W, et al. Epidemiology, genetic recombination, and pathogenesis of coronaviruses. Trends Microbiol 2016;24:490-502.PMID:27012512 D01:10.10161j.tim.2016.03.003

4. Cui J, Li F, Shi ZL. Origin and evolution of pathogenic coronaviruses. Nat Rev Microbial 2019; 17:181-192. PMID:30531947 D01.10 1038/s41579-018-0118-9

5. World Health Organization (WHO). Coronovirus. https://www.who.int/health-topics/coronavirus


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We are a residential service agency and we provide skilled-nursing home service care, durable medical equipment, oxygen services and physical therapy.

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NEW YORK OFFICE

1463 Fifth Avenue,

Suite #100 1st Floor,

New York, NY 10035

Phone. 888.886.1167

Email. info@standardmed.us

MARYLAND OFFICE

8115 Maple Lawn Blvd.,

Suite #350 3rd Floor,

Fulton, MD 20759

Phone. 888.886.1167

Email. info@standardmed.us

FLORIDA OFFICE

1726 Lambert Street,

Jacksonville, FL 32206

Phone. 888.886.1167

Email. info@standardmed.us

Standard Medical Equipment Systems, LLC, Hospital Supplies, Fulton, MD