Constraints, Criteria, Standards

Constraints and criteria include, but not limited to:

Constraints

Simple operation: Final microscope must be operable by individuals without direct training
Power supply: The final product must not rely on a power source
Optics: Need to be available and easy to focus/operate
Transportability: Ease at which the unit can be moved.

Criteria

Need at least 100 images of fluorescing acid-fast bacillus to develop a machine learning process.
Can operate at 3 watts for 48 hours without needing charge.
Keep final cost under $200 per unit.
Microscope and algorithm must detect TB to 99% accuracy.

Standards

Standards 1 & 2: According to the U.S. Department of Health and Human Services, Biosafety Level 2 (BSL-2) laboratories are used to study infectious agents or toxins that pose a moderate risk to human safety; the study of MTB would be considered a moderate infectious agent.

“Design requirements for BSL-2 laboratories include hand washing sinks, eye washing stations, and doors that close and lock automatically.
BSL-2 laboratories must also have access to equipment that can decontaminate laboratory waste, including an incinerator, an autoclave, and/or another method of decontamination, depending on the biological risk assessment” [1].

Standard 3: The Centers for Disease Control and Prevention (CDC) has provided a classification scale for sputum smear results identified from fluorescence microscopy. The system is shown below [2].

Standard 4: The WHO released the Standard Operating Procedure (SOP) for Auramine staining that describes personnel qualifications as well as an in-depth procedure for staining. Auramine staining is the gold standard for detecting TB with fluorescence microscopy [3].

References

[1] Biosafety Level Requirements. (n.d.). Retrieved November 28, 2020, from https://www.phe.gov/s3/BioriskManagement/biocontainment/Pages/BSL-Requirements.aspx

[2] Laboratory Examination: Acid-Fast Bacilli (AFB) Smears (2). (n.d.). Retrieved November 28, 2020, from https://www.cdc.gov/tb/webcourses/Course/chapter4/4_diagnosis_of_tb_disease_4_diagnostic_microbiology_laboratory_examination_acid_fast_bacilli_afb_smears_2_.html

[3] [TB] SOP for auramine staining | Laboratory Quality Stepwise Implementation tool. (n.d.). Retrieved December 9, 2020, from https://extranet.who.int/lqsi/content/tb-sop-auramine-staining

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