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Home Collection Kit FAQ

Updated

Why is it important to get tested for STIs/STDs? 

  • According to the World Health Organization (WHO), almost 1 million sexually transmitted infections (STIs) are transmitted daily. (Alternatively: The Center for Disease Control and Prevention (CDC) estimates that there are millions of new STD infections in the US each year.) Although most STIs/STDs can be treated with antibiotics or antiviral drugs, many have no noticeable symptoms. The iHealth CheckMeSafe Home Collection Kit is a fast and convenient way to get tested for these infections from the comfort of your home. With lab-grade accuracy and reliable results, you can know your status quickly and discreetly. By getting tested regularly, you are protecting your health and helping to control the spread of STIs/STDs.

Who should use the iHealth CheckMeSafe Critical 2 Home Collection Kit? 

  • The iHealth CheckMeSafe Critical 2 Home Collection Kit enables anyone over the age of 18 to collect a blood sample to test for HIV (I, II, P24 antigen) and syphilis at our CLIA-certified partner laboratory. 
  • According to the Center for Disease Control and Prevention (CDC):
    • Everyone between the ages of 13 and 64 should get tested for HIV at least once as part of routine healthcare. (Note that the Home Collection Kit should only be used by adults over the age of 18.)
    • Sexually active men who have sex with men should get tested at least once a year for syphilis and HIV. Those who have multiple or anonymous partners may benefit from more frequent testing (e.g. every 3 to 6 months). 
    • Everyone who is pregnant should also get tested for HIV and syphilis starting early in pregnancy.

How long should I wait to get tested after a possible exposure?/How soon can the lab detect an infection?

  • The window periods (the time between when someone is infected and when the infection can be detected by a test) of HIV and syphilis vary from person to person and also depend upon the type of test. The HIV screening used by our partner lab can detect an infection 18 to 90 days after an exposure. The syphilis test can detect an infection 14 to 84 days after an exposure. You do not need to develop any symptoms for the tests to accurately detect an infection.
  • Keep in mind, you can only be sure you are HIV- and syphilis-negative if your most recent blood collection is after the window period and you haven’t had a possible exposure during the window period. 

What are my options to get tested?

  • HIV and syphilis screening can be done with blood drawn from a vein by a healthcare provider (i.e. venipuncture) or obtained through the finger-prick method. 
    • You might need a doctor prescription and/or an appointment to get tested for STDs near you through venipuncture, but it might detect an infection sooner. Certain local health clinics and nonprofit organizations might also offer free or low-cost STD testing. 
    • The iHealth CheckMeSafe Critical 2 Home Collection Kit uses the finger-prick method and can be completed from the comfort of your home without a prescription. It is clinically proven to be as reliable as the tests used in hospitals and reference labs. 
    • HIV screening on oral fluid and urine is also an option but tends to be less accurate than blood tests. 
    • Common syphilis testing methods include the Rapid Plasma Reagin (RPR) test and the Venereal Disease Research Laboratory (VDRL) test, both of which tend to have a higher likelihood of false-positive results compared to Treponemal tests such as the one used by iHealth’s partner lab. 

What are the symptoms of HIV?

  • Within weeks after an HIV infection, about two-thirds of people develop flu-like symptoms, including:
    • Fever
    • Chills
    • Rash
    • Night sweats
    • Muscle aches
    • Sore throat
    • Fatigue
    • Swollen lymph nodes
    • Mouth ulcers
  • Without timely treatment, HIV can lead to AIDS (acquired immunodeficiency syndrome), which might include the following symptoms:
    • Rapid weight loss
    • Recurring fever or profuse night sweats
    • Extreme and unexplained tiredness
    • Prolonged swelling of the lymph glands in the armpits, groin, or neck
    • Diarrhea that lasts for more than a week
    • Sores of the mouth, anus, or genitals
    • Pneumonia
    • Red, brown, pink, or purplish blotches on or under the skin or inside the mouth, nose, or eyelids
    • Memory loss, depression, and other neurologic disorders

What are the symptoms of syphilis?

  • Syphilis progresses through four stages. It usually starts as a painless sore on or around the genitals, rectum or mouth. Further symptoms could include: 
    • Skin rashes
    • Fever
    • Swollen lymph glands
    • Sore throat
    • Patchy hair loss
    • Headaches
    • Weight loss
    • Muscle aches
    • Fatigue

How accurate is the iHealth CheckMeSafe Critical 2 Home Collection Kit?

  • Our partner laboratory meets the highest levels of accreditation. For HIV screening, the lab uses a 4th generation antigen/antibody combination assay that was validated to be 99.9% sensitive (accurate for positive results) and 99.6% specific (accurate for negative results) in FDA approval data. The lab’s syphilis testing method was validated to be 98.5% sensitive and 82.6% specific. During method verification, the test was 100% accurate for both positive and negative results. 

Is the iHealth CheckMeSafe Critical 2 Home Collection Kit approved by the FDA?

  • The HIV and syphilis screening systems used by our partner laboratory are approved by the FDA. The iHealth CheckMeSafe Critical 2 Home Collection Kit, an in vitro diagnostics device, is listed with the FDA.

Where is the iHealth CheckMeSafe Critical 2 Home Collection Kit available? 

  • The iHealth CheckMeSafe Critical 2 can be shipped within the contiguous US, except for New York, and Rhode Island, due to state regulations.
  • The iHealth CheckMeSafe Critical 2 is not available outside the United States. 

When should I collect and return my sample?

  • The sample must be collected between Monday and Thursday and shipped on the same day. Do not use the kit on or right before a public holiday to avoid shipping delays. 
  • Each kit comes with a return envelope and a prepaid return label. Please consult the instruction sheet for further information about dropping off the sample or arranging a pickup. 

How will I receive my results?

  • As soon as two days after returning the sample, you will receive an email notification to let you know that the lab has processed your sample. You can then log into the secure online portal to view and download your results. We do not send your results directly via email or text. Please note that additional sample processing time might be required for special conditions. Improper collection may result in delays or invalid results. 

What does a positive result mean?

  • A positive HIV result means that HIV antigens and/or antibodies were detected in the sample and the individual providing the blood sample is infected with HIV.
  • A positive syphilis result means that the antibodies to Treponema pallidum, the bacterium that causes syphilis, were detected in the sample and the individual providing the blood sample is infected with syphilis. 
  • If you receive a positive result, please consult your healthcare provider as soon as possible about treatment options. 

What does a negative result mean?

  • A negative HIV result means that HIV antigens and/or antibodies were not detected in the blood sample. 
  • A positive syphilis result means that antibodies to Treponema pallidum, the bacterium that causes syphilis, were not detected in the blood sample. 

What does an invalid result mean?

  • An invalid HIV result means that the lab was not able to confirm the presence of HIV antigens and/or antibodies in the blood sample. Retesting might be recommended for a conclusive result. 
  • An invalid syphilis result means that the lab was not able to confirm the presence of antibodies to Treponema pallidum, the bacterium that causes syphilis, in the blood sample. Retesting might be recommended for a conclusive result. 

What could lead to an invalid test result?

  • Possible reasons for an invalid test result include:
    • Insufficient sample;
    • Sample not returned on the day of collection;
    • Sample returned on a Friday, Saturday, Sunday, public holiday or the day before a public holiday;
    • Sample collection tube leakage;
    • Shipment exceptions.

How is my personal information protected?

  • During the kit activation process, we ask for only the information that is required by federal and state regulations. Your information will be stored and transmitted in compliance with HIPAA laws.

Does health insurance or HSA/FSA cover the iHealth CheckMeSafe Critical 2 Home Collection Kit?

  • Currently, the CheckMeSafe Critical 2 Home Collection Kit is not covered by health insurance. However, it may be more affordable than paying out-of-pocket for tests that are covered by insurance.
  • Depending on your HSA/FSA provider, the Home Collection Kit may be eligible for reimbursement. Please contact your HSA/FSA provider to confirm eligibility before making a purchase. 

What is the refund and replacement policy?

  • The following refund and replacement policy pertains to CheckMeSafe Home Collection Kits purchased on iHealthlabs.com and the iHealth Labs store on amazon.com. To qualify for a refund or replacement, you must provide proof of purchase and the kit ID. Please note that products obtained from unauthorized resellers are not eligible for refunds or replacements.
  • You are eligible for a full refund if your order has not been shipped.
  • In cases where you haven't returned your sample and the order was placed within the last 30 days, a deduction of $15 will be subtracted from the full refund to cover shipping and handling costs. Please note that iHealth Labs cannot accept returned kits. Dispose of the kit following local regulations.
  • Orders placed more than 30 days ago are not eligible for refunds or replacements.
  • Home Collection Kits that have been sent back to the lab for sample processing cannot be refunded. However, if your test results are invalid, we will contact you and send a replacement kit.
  • To ensure proper sample processing, all Home Collection Kits must be activated, and the samples must be returned to our partner lab before the expiration date printed on the Kit. 

Sources and additional information

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