Manufacturing Point-of-Care Diagnostic Kits—Speed, Precision, and Scalability
The demand for point-of-care (POC) diagnostic kits is at an all-time high. These compact, easy-to-use test kits are revolutionizing how healthcare is delivered—bringing diagnostics from labs into clinics, homes, and field settings. But behind each seemingly simple device is a highly specialized manufacturing process that requires tight quality control, sterile assembly, and regulatory alignment.
At Ciro Manufacturing, we provide full-service POC diagnostic kit manufacturing from plastic molding to cleanroom kitting—ensuring your device is built to perform, scale, and comply with global standards.
What Are Point-of-Care Diagnostic Kits?
POC diagnostic kits enable rapid testing and decision-making at or near the site of patient care. These kits often include:
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Sample collection tools (swabs, lancets, collection tubes)
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Reaction chambers or test cassettes (lateral flow, cartridge-based, etc.)
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Liquid reagents or buffers
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Instructions and labeling
POC tests must be intuitive, fast, and accurate—and they must be produced under conditions that ensure consistency and clinical reliability.
Ciro’s Turnkey POC Kit Manufacturing Capabilities
1. Plastic Injection Molding for Device Components
We mold test housings, swab handles, reagent cartridges, and other POC kit components in-house under ISO 13485 controls. Materials include PP, PC, ABS, COC, and more—selected for sterilizability, chemical compatibility, and user safety.
2. Cleanroom Assembly (ISO Class 6)
Our cleanroom environment ensures sterile assembly of test components:
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Integration of membranes or absorbent pads (lateral flow devices)
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Application of adhesive seals or foils
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Kit configuration and subcomponent packaging
3. Sterile Liquid Filling & Buffer Integration
Our sterile fill lines handle reagents, buffers, and stabilizing agents:
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Fill volumes from 0.5 mL to 100 mL
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Tamper-evident capping
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Batch traceability and lot-level QC
4. Kitting & Packaging
We provide:
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Single-test, multi-test, and bulk packaging
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IFU printing and folding
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Branding, barcoding, and serialized labels
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Shipping prep for cold chain or ambient conditions
Regulatory Readiness Built In
Our ISO 13485-certified QMS supports regulatory pathways including:
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FDA 510(k) or EUA submissions
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CE/IVDR compliance
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Clinical trial kit deployment
We provide:
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Device Master Records (DMRs) and Device History Records (DHRs)
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Full validation and verification (V&V) protocols
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Audit-ready SOPs and traceable batch records
Ideal POC Applications We Support
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Infectious disease screening (COVID-19, flu, RSV)
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Women’s health (pregnancy, ovulation)
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Chronic disease monitoring (glucose, HbA1c)
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Drug screening and toxicology
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Rapid blood or saliva testing kits
Whether you're scaling a diagnostic breakthrough or launching a pilot test, our infrastructure supports you every step of the way.
Case Study: Rapid Scale-Up of COVID-19 Antigen Test Kits
A diagnostics startup needed to scale a lateral flow COVID-19 test kit within 45 days. Ciro provided:
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Molded plastic housings and swab components
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Cleanroom pad assembly and cartridge sealing
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Reagent fill and tamper-evident labeling
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Full kitting, palletization, and shipping
Result: Over 500,000 units delivered with ISO 13485 documentation—used in nationwide health programs.
Final Thought: Manufacturing Kits That Build Confidence at the Point of Care
Point-of-care testing demands precision, reliability, and speed. At Ciro Manufacturing, we build POC kits that deliver on all three—with in-house expertise that turns complex components into cohesive, compliant products.
👉 Ready to bring your diagnostic vision to life? Let’s build it together.
