ALLRANGEKIT™ PRODUCT CONSENT

Last Updated: July 23, 2025

This Product Consent explains what you're agreeing to when you purchase and use AllrangeKit™ testing products. Please read this document carefully to understand your rights, responsibilities, and what we're authorized to do with your samples and information.

1. CONSENT TO AT-HOME TESTING SERVICES

By purchasing and using AllrangeKit™ products, you consent to:

Self-collection of biological samples at home
Laboratory analysis of your samples by CLIA-certified facilities
Use of molecular diagnostic testing methods (including PCR technology)
Electronic delivery of results through secure online access
Clinical review of your test request by licensed healthcare providers
Use of your test data for quality improvement and regulatory compliance

You understand that:

These are screening tests for informational purposes
Results do not constitute a medical diagnosis
You should consult healthcare providers for medical advice
You are responsible for appropriate follow-up care

2. PRODUCT AUTHORIZATION AND SCOPE

This consent applies to all AllrangeKit™ testing products including:

STI (Sexually Transmitted Infection) screening panels
HPV (Human Papillomavirus) testing
GI (Gastrointestinal) pathogen testing
UTI (Urinary Tract Infection) testing
Future wellness and screening tests we may offer

You authorize us to:

Process your test orders through our platform
Facilitate laboratory testing of your samples
Deliver results electronically to your secure account
Contact you regarding your test status and results
Store your information as outlined in our Privacy Policy

3. ELIGIBILITY CONFIRMATION

By using our products, you confirm that you:

Are at least 18 years of age
Are located in the United States
Have the legal capacity to provide this consent
Will provide only your own biological samples
Understand English sufficiently to comprehend these terms
Accept responsibility for following all instructions

You acknowledge that:

Some states have restrictions on direct-to-consumer testing
We will verify service availability for your location
Providing false information may result in service denial

4. SAMPLE COLLECTION CONSENT

You consent to and understand:

Collection Requirements:

Improper collection may result in invalid results
You are responsible for collection errors
You must follow all provided instructions exactly
Samples must be your own biological material
Under federal Clinical Laboratory Improvement Amendments (CLIA) regulations and guidelines, our laboratory maintains strict chain-of-custody and specimen integrity and acceptability standards. Any sample arriving unregistered, lacking proper identification (unlabeled), damaged or otherwise unusable or collected in violation of the Instructions for Use (IFU) is legally invalid and will be safely discarded upon receipt without processing. You will be notified and you may request a replacement kit in these instances, subject to an additional fee.

Sample Types You Authorize:

Urine collection for applicable tests
Self-collected vaginal swabs where required
Stool samples for GI testing
Blood samples via finger prick if applicable
Other sample types as specified in your kit

Safety Acknowledgment:

You will maintain sanitary conditions during collection
You will use only the provided collection materials
You will properly dispose of any biohazard materials
You accept any risks associated with self-collection

5. LABORATORY TESTING AUTHORIZATION

You authorize and understand:

Clinical Review:

A licensed healthcare provider will review your test request
Tests may be denied if not medically appropriate
Additional information may be requested
State regulations govern authorization requirements

Laboratory Processing:

Your samples will be tested at CLIA-certified laboratories
Advanced molecular diagnostic methods will be used
Standard laboratory protocols will be followed
Quality control measures are in place

Results Delivery:

Results typically available in 2-5 business days
Delivered only through secure electronic means
You must check your account for results
We may attempt contact for critical values

6. UNDERSTANDING OF TEST LIMITATIONS

You acknowledge and accept that:

Accuracy Limitations:

No test is 100% accurate
False positive and false negative results can occur
Many factors affect test accuracy including:

Sample quality and collection method
Timing relative to exposure (window periods)
Individual biological factors
Technical limitations

Screening vs. Diagnosis:

These are screening tests only
Positive results require medical confirmation
Negative results don't guarantee absence of condition
Results must be interpreted by healthcare providers

Medical Care:

These tests don't replace regular medical care
You must seek care for concerning symptoms
Emergency situations require immediate medical attention
Follow-up testing may be necessary

7. PRIVACY AND DATA USE CONSENT

You consent to:

Information Collection:

Collection of personal and health information
Use of information for test processing
Storage of data per our Privacy Policy
Communication about your tests and results

Protected Health Information:

HIPAA protections apply to your health data
Information shared only as you authorize
Required reporting to public health authorities
Use for legally required purposes

Data Security:

Encryption of data in transit and storage
Access limited to authorized personnel
Security measures per industry standards
Breach notification if required

8. REPORTING OBLIGATIONS

You understand and consent that:

Certain infections must be reported to public health authorities by law
This reporting helps prevent disease spread
Your identity is protected to the extent allowed by law
You may be contacted by health departments
Partner notification may be recommended or required

You acknowledge this is:

A legal requirement for laboratories
Important for public health protection
Not optional based on your preferences
Conducted with privacy protections

9. FINANCIAL CONSENT

You agree to:

Pay all fees at time of purchase
No refunds after sample processing begins
Your responsibility for all costs
Insurance typically doesn't cover these tests
Additional costs for follow-up care

You understand:

Prices are subject to change
Replacement kits are provided free of charge only for manufacturer defects. Replacement kits necessitated by user error (e.g., failing to register, label sample errors, not following instructions or any other issue that was a non-manufacturer or company related problem) will be rejected. There will be a fee for a replacement kit for any of these type errors.
HSA/FSA eligibility varies
Confirmatory testing costs extra

10. ASSUMPTION OF RISKS

You acknowledge and accept:

Testing Risks:

Possibility of inconclusive results
Emotional impact of results
Need for medical follow-up
Limitations of screening tests

Collection Risks:

Minor discomfort during collection
Possibility of contamination
Risk of inadequate samples
Responsibility for proper technique

General Risks:

Delays in processing or results
Technical issues with access
Need for recollection
Importance of proper follow-up

11. RELEASE AND INDEMNIFICATION

To the extent permitted by law, you:

Release AllrangeKit™ from liability for authorized services
Accept responsibility for following instructions
Acknowledge voluntary use of services
Agree to indemnify us for misuse of products
Understand limitations of screening tests

This includes release from:

Emotional distress from results
Consequences of delayed medical care
Issues from sample self-collection
Results interpretation without medical consultation

12. SPECIFIC ACKNOWLEDGMENTS

For STI/HPV Testing:

Window periods affect detection
Partner testing may be necessary
Some infections have no cure
Regular screening is important

For Pregnancy:

Many infections affect pregnancy
Early detection is crucial
Results must be shared with prenatal provider
Special precautions may be needed

For All Tests:

Follow-up care is your responsibility
Positive results need confirmation
Medical consultation is essential
Prevention remains important

13. CONSENT DURATION AND WITHDRAWAL

This consent:

Takes effect upon product purchase
Remains valid through result delivery
Covers the specific test(s) ordered
May be withdrawn before sample submission

To withdraw consent:

Contact customer support immediately
No withdrawal after lab receives sample
Refunds subject to our policy
Some obligations survive withdrawal

14. CALIFORNIA PRIVACY RIGHTS

California residents have additional rights under state law:

Right to know what information we collect
Right to delete certain information
Right to opt-out of information sales (we don't sell data)
Right to non-discrimination for exercising rights

See our Privacy Policy for details on exercising these rights.

15. AGREEMENT TO TERMS

By purchasing our products, you acknowledge:

You have read and understood this consent
You voluntarily agree to these terms
You have authority to provide this consent
You accept the limitations described
You will seek appropriate medical care
You will provide accurate information
You understand your responsibilities

This consent incorporates by reference:

Our Specific Terms Relating to Lab Services and Products
Our Privacy Policy
Our HIPAA Notice
Specific test information provided

Contact Information

Customer Support

📧 Email: support@allrangekit.com

📞 Phone: +1 (608) 879-8173

🕒 Hours: Monday-Friday, 7:00 AM - 4:00 PM PST

Legal Inquiry

📍 Mail: OPEN Healthcare, 1487 W 178th St., Gardena, CA 90248

ATTN: Legal Inquiry