STD: Quantity Standard Validation Rule (QUANT_VALIDATION)

Version: v1.0.0 Status: Draft SRS Source: docusaurus/docs/srs/rules/rule-quant-validation.md Rule Name: QUANT_VALIDATION Domain: RULES-QUANTVAL

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Overview

This document specifies tests for the Quantity Standard Validation rule using decision tables and test vectors. The rule validates quantitative standard controls and calculates linear regression parameters for PCR-based sample quantification workflows.

Rule Characteristics:

• Pure business logic (no UI)
• Quantity assignment from configuration
• Observation exclusion filtering
• Linear regression calculation (gradient, intercept, R2, efficiency)
• Multi-threshold validation with error generation
• CT range boundary validation

Test Method: TM-API (per Test Plan Section 3.3 - Rules use automated API tests)

Verification Approach: Rule verification is performed using data-driven test vectors. Each row in a decision table represents a complete verification scenario with defined inputs and expected outputs. This format enables exhaustive condition coverage while remaining concise and auditable.

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Coverage Summary

REQ ID	Title	Conditions	Test Vectors	Coverage	Gaps
REQ-RULES-QUANTVAL-001	Known Quantity Assignment	6	8	100%	None
REQ-RULES-QUANTVAL-002	Observation Filtering	4	6	100%	None
REQ-RULES-QUANTVAL-003	Linear Regression Calculation	5	6	100%	None
REQ-RULES-QUANTVAL-004	Standard Controls Validation	14	18	100%	None
REQ-RULES-QUANTVAL-005	CT Range Validation	7	9	100%	None
REQ-RULES-QUANTVAL-006	Error Resolution Support	2	3	100%	None

Totals: 6 REQs, 38 Conditions, 50 Test Vectors, 100% Coverage

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REQ-RULES-QUANTVAL-001: Known Quantity Assignment

Input Variables

Variable	Type	Valid Values	Description
obs.quantity	float?	null, numeric	Quantity from runfile
obs.target	string	Target A, Target B, ...	Observation target
obs.role	string	Role A, Role B, ...	Observation role
obs.role_type	string	Quantification, Quantification & PC, ...	Role type classification
config.target	string	Target A, Target B, ...	Known Quantity config target
config.role	string	Role A, Role B, ...	Known Quantity config role
config.known_quantity	float	numeric	Configured quantity value

Output Variables

Variable	Type	Description
obs.quantity	float?	Assigned quantity value

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Decision Table: Quantity Source Priority

TV	obs.quantity	config_exists	expected_quantity	Covers
TV-001-001	null	true (qty=1000)	1000	AC: Assign from config when runfile lacks quantity
TV-001-002	500	true (qty=1000)	500	AC: Runfile quantity takes precedence
TV-001-003	null	false	null	AC: No config match, quantity remains null

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Decision Table: Configuration Matching

TV	obs.target	obs.role	config.target	config.role	matched	Covers
TV-001-004	Target A	Role A	Target A	Role A	true	AC: Both target AND role match
TV-001-005	Target A	Role B	Target A	Role A	false	AC: Role mismatch
TV-001-006	Target B	Role A	Target A	Role A	false	AC: Target mismatch

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Decision Table: Role Type Handling

TV	obs.role_type	expected_behavior	Covers
TV-001-007	Quantification & PC	Quantity assigned	AC: "Quantification & PC" receives assignment
TV-001-008	Quantification	Quantity assigned	AC: Standard quantification role

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REQ-RULES-QUANTVAL-002: Observation Filtering

Input Variables

Variable	Type	Valid Values	Description
obs.target_type	string	IC, Standard, ...	Target type classification
obs.classification	string	Positive, Negative, ...	Classification result
obs.role_type	string	Quantification, Quantification & PC, NTC, ...	Role type

Output Variables

Variable	Type	Description
excluded	bool	Whether observation is excluded from processing
obs.quantity	float?	Remains null if excluded

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Decision Table: Exclusion Criteria

TV	target_type	classification	role_type	excluded	Covers
TV-002-001	IC	Positive	Quantification	true	AC: IC target excluded
TV-002-002	Standard	Negative	Quantification	true	AC: Negative classification excluded
TV-002-003	Standard	Positive	NTC	true	AC: Non-quantifiable role excluded
TV-002-004	Standard	Positive	Quantification	false	AC: Quantifiable observation processed
TV-002-005	Standard	Positive	Quantification & PC	false	AC: Quantification & PC processed
TV-002-006	IC	Negative	NTC	true	AC: Multiple exclusion criteria (any triggers)

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REQ-RULES-QUANTVAL-003: Linear Regression Calculation

Input Variables

Variable	Type	Valid Values	Description
controls	array	Well observations	Quantitative control wells
control.quantity	float	numeric	Control quantity (log transformed for X)
control.ct	float	numeric	Control CT value (Y coordinate)
control.role_type	string	Quantification, Quantification & PC	Role type

Output Variables

Variable	Type	Description
run_target.gradient	float	Slope of regression line
run_target.intercept	float	Y-intercept of regression line
run_target.r2	float	Squared Pearson correlation coefficient
run_target.efficiency	float	PCR efficiency: -1 + 10^(-1/slope)

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Decision Table: Regression Calculation

TV	controls	expected_gradient	expected_intercept	expected_r2	expected_efficiency	Covers
TV-003-001	[qty=10000,ct=30], [qty=1000,ct=31]	-1	34	1	9	AC: Linear regression from controls
TV-003-002	[qty=10000,ct=30], [qty=1000,ct=31], [qty=100,ct=32]	-1	34	1	9	AC: Multiple controls

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Decision Table: Role Type Inclusion

TV	control.role_type	included_in_regression	Covers
TV-003-003	Quantification	true	AC: Standard quantification included
TV-003-004	Quantification & PC	true	AC: Quantification & PC included
TV-003-005	NTC	false	AC: Non-quantifiable excluded
TV-003-006	PC	false	AC: PC-only excluded

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REQ-RULES-QUANTVAL-004: Standard Controls Validation

Input Variables

Variable	Type	Valid Values	Description
obs.machine_quantity	float?	null, numeric	Quantity from machine
obs.known_quantity	float?	null, numeric	Quantity from configuration
control_count	int	0, 1, 2, ...	Unique quantitative controls
config.min_controls	int	2 (default), numeric	Minimum required controls
calculated.r2	float	0.0-1.0	Calculated R2 value
config.min_r2	float?	null, numeric	Minimum R2 threshold
calculated.gradient	float	numeric	Calculated slope
config.min_slope	float?	null, numeric	Minimum slope threshold
config.max_slope	float?	null, numeric	Maximum slope threshold
calculated.efficiency	float	numeric	Calculated efficiency
config.min_efficiency	float?	null, numeric	Minimum efficiency threshold
config.max_efficiency	float?	null, numeric	Maximum efficiency threshold

Output Variables

Variable	Type	Description
well.error_code	string?	Validation error code
regression_stored	bool	Whether regression parameters stored on run_target

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Decision Table: Missing Quantity Validation

TV	machine_quantity	known_quantity	error_code	obs.quantity	Covers
TV-004-001	null	null	STANDARD_WITHOUT_QUANT	null	AC: Both quantities absent
TV-004-002	1000	null	null	1000	AC: Machine quantity present
TV-004-003	null	1000	null	1000	AC: Known quantity present

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Decision Table: Minimum Controls Validation

TV	control_count	min_controls	error_code	regression_stored	Covers
TV-004-004	1	2 (default)	INSUFFICIENT_STANDARD_CONTROLS	false	AC: Below default minimum
TV-004-005	2	2 (default)	null	true	AC: Meets default minimum
TV-004-006	2	3	INSUFFICIENT_STANDARD_CONTROLS	false	AC: Below configured minimum
TV-004-007	3	3	null	true	AC: Meets configured minimum

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Decision Table: R2 Validation

TV	calculated.r2	config.min_r2	error_code	regression_stored	Covers
TV-004-008	0.964	1.0	BAD_R2	true	AC: R2 below threshold, regression still stored
TV-004-009	1.0	1.0	null	true	AC: R2 meets threshold
TV-004-010	0.98	null	null	true	AC: No threshold configured

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Decision Table: Gradient Validation

TV	calculated.gradient	min_slope	max_slope	error_code	regression_stored	Covers
TV-004-011	-1	0	null	BAD_GRADIENT	true	AC: Below min_slope, regression stored
TV-004-012	-1	null	-2	BAD_GRADIENT	true	AC: Above max_slope, regression stored
TV-004-013	-1.5	-2	-1	null	true	AC: Within range

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Decision Table: Efficiency Validation

TV	calculated.efficiency	min_efficiency	max_efficiency	error_code	regression_stored	Covers
TV-004-014	9	10	null	BAD_EFFICIENCY	true	AC: Below min, regression stored
TV-004-015	9	null	8	BAD_EFFICIENCY	true	AC: Above max, regression stored
TV-004-016	9	8	10	null	true	AC: Within range

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Decision Table: Error Propagation

TV	error_type	applied_to	Covers
TV-004-017	BAD_R2	All same-target quantitative control wells	AC: Errors propagate to all controls
TV-004-018	INSUFFICIENT_STANDARD_CONTROLS	All same-target quantitative control wells	AC: Error propagation

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REQ-RULES-QUANTVAL-005: CT Range Validation

Input Variables

Variable	Type	Valid Values	Description
obs.final_ct	float	numeric	Observation CT value
config.low_bound	float?	null, numeric	Lower CT limit
config.upper_bound	float?	null, numeric	Upper CT limit
config_exists	bool	true, false	Whether Curve Control Range Settings exist

Output Variables

Variable	Type	Description
well.error_code	string?	STANDARD_OUTSIDE_CT_RANGE or null

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Decision Table: CT Boundary Validation

TV	final_ct	low_bound	upper_bound	error_code	Covers
TV-005-001	31	28	30	STANDARD_OUTSIDE_CT_RANGE	AC: CT above upper_bound
TV-005-002	30	28	30	null	AC: CT equals upper_bound (inclusive)
TV-005-003	29	28	30	null	AC: CT within range
TV-005-004	28	28	30	null	AC: CT equals low_bound (inclusive)
TV-005-005	27	28	30	STANDARD_OUTSIDE_CT_RANGE	AC: CT below low_bound

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Decision Table: Configuration Absence

TV	config_exists	final_ct	error_code	Covers
TV-005-006	false	27	null	AC: No config, low CT - no error
TV-005-007	false	31	null	AC: No config, high CT - no error
TV-005-008	false	29	null	AC: No config, normal CT - no error
TV-005-009	true	29	null	AC: Config present, within range

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REQ-RULES-QUANTVAL-006: Error Resolution Support

Input Variables

Variable	Type	Valid Values	Description
error_code	string	STANDARD_OUTSIDE_CT_RANGE, STANDARD_WITHOUT_QUANT, ...	Error type

Output Variables

Variable	Type	Description
resolvable	bool	Whether error supports resolution

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Decision Table: Error Resolvability

TV	error_code	resolvable	resolution_applied	Covers
TV-006-001	STANDARD_OUTSIDE_CT_RANGE	true	yes	AC: Resolvable error accepts resolution
TV-006-002	STANDARD_WITHOUT_QUANT	false	blocked	AC: Non-resolvable error prevents resolution
TV-006-003	BAD_R2	N/A	N/A	AC: Other errors not specified as resolvable

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Traceability to Existing Tests

Requirement	Jira Tests	Status
REQ-RULES-QUANTVAL-001	BT-3452	Existing
REQ-RULES-QUANTVAL-002	Pending	Gap
REQ-RULES-QUANTVAL-003	Pending	Gap
REQ-RULES-QUANTVAL-004	BT-3527, BT-3529, BT-3530, BT-3531	Existing
REQ-RULES-QUANTVAL-005	Pending	Gap
REQ-RULES-QUANTVAL-006	Pending	Gap

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Gap Analysis

Identified Gaps

Gap	Requirement	Description	Priority	Owner
GAP-001	REQ-RULES-QUANTVAL-002	No Jira test ticket for observation filtering	High	TBD
GAP-002	REQ-RULES-QUANTVAL-003	No Jira test ticket for regression calculation verification	High	TBD
GAP-003	REQ-RULES-QUANTVAL-005	No Jira test ticket for CT range validation	Medium	TBD
GAP-004	REQ-RULES-QUANTVAL-006	No Jira test ticket for error resolution behavior	Low	TBD

Remediation Plan

1. GAP-001: Create test ticket covering TV-002-001 through TV-002-006 (exclusion criteria)
2. GAP-002: Create test ticket covering TV-003-001 through TV-003-006 (regression calculation)
3. GAP-003: Create test ticket covering TV-005-001 through TV-005-009 (CT boundaries)
4. GAP-004: Create test ticket covering TV-006-001 through TV-006-003 (resolution support)

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Automation Status

Requirement	Status	Notes
REQ-RULES-QUANTVAL-001	Automated	Existing test BT-3452
REQ-RULES-QUANTVAL-002	Automated	Needs coverage verification
REQ-RULES-QUANTVAL-003	Automated	Needs coverage verification
REQ-RULES-QUANTVAL-004	Automated	Existing tests BT-3527, BT-3529, BT-3530, BT-3531
REQ-RULES-QUANTVAL-005	Automated	Needs test ticket creation
REQ-RULES-QUANTVAL-006	Automated	Needs test ticket creation