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:
- You must follow all provided instructions exactly
- Improper collection may result in invalid results
- You are responsible for collection errors
- No refunds for user error in collection
- Samples must be your own biological material
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 only for defects
- 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
Legal Inquiry
📍 Mail: OPEN Healthcare, 1487 W 178th St., Gardena, CA 90248
ATTN: Legal Inquiry
© 2025, Open Healthcare US, Inc. d/b/a AllrangeKit™. All rights reserved.