STD: Standard Curve Validation Rule (STDQT)

Version: v1.0.0 Status: Draft SRS Source: docusaurus/docs/srs/rules/rule-standard-curve-validation.md Rule Name: STDQT Domain: RULES-STDCURVE

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Overview

This document specifies tests for the Standard Curve Validation rule using decision tables and test vectors. The rule validates CT (cycle threshold) values against configured limits and verifies PCR amplification curve correlation (R-squared) with the standard curve before calculating quantity values.

Rule Characteristics:

• Pure business logic (no UI)
• Sequential validation (applicability, CT range, R2, quantity calculation)
• Configurable limits per mix/target
• Mathematical calculation (R2, quantity formula)

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-STDCURVE-001	Validate CT Values Against Standard Curve Parameters	15	22	100%	None

Totals: 1 REQ, 15 Conditions, 22 Test Vectors, 100% Coverage

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REQ-RULES-STDCURVE-001: Validate CT Values Against Standard Curve Parameters

Input Variables

Variable	Type	Valid Values	Description
config.has_std_curve	bool	true, false	Whether mix/target has standard curve configuration
config.ct_lower_limit	float?	null, numeric	Minimum acceptable CT value
config.ct_upper_limit	float?	null, numeric	Maximum acceptable CT value
config.r2_threshold	float	0.0-1.0 (default 0.99)	Minimum R-squared correlation coefficient
config.slope	float	numeric (non-zero)	Standard curve regression slope
config.intercept	float	numeric	Standard curve regression intercept
obs.ct_value	float?	null, NaN, numeric	Observed cycle threshold value
obs.curve_data	array	data points	Standard curve data for R2 calculation
calc.r2_value	float	0.0-1.0	Calculated R-squared from regression

Output Variables

Variable	Type	Description
rule.triggered	bool	Whether the rule validation failed
rule.failure_reason	string?	CT_BELOW_LOWER_LIMIT, CT_ABOVE_UPPER_LIMIT, POOR_CURVE_FIT, or null
rule.status	string	NOT_APPLICABLE, PASSED, FAILED, ERROR
well.quantity	float?	Calculated quantity (only if validation passes)

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Decision Table: Applicability Check

TV	has_std_curve	ct_limits_config	ct_value	status	triggered	Covers
TV-001-001	false	-	-	NOT_APPLICABLE	false	AC: Skip rule for mixes/targets without standard curve configuration
TV-001-002	true	missing	25	ERROR	false	AC: Missing CT limits configuration logs error and skips rule
TV-001-003	true	present	null	ERROR	false	AC: Invalid CT value (null) logs error and skips validation
TV-001-004	true	present	NaN	ERROR	false	AC: Invalid CT value (NaN) logs error and skips validation

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Decision Table: CT Range Validation

TV	ct_lower	ct_upper	ct_value	triggered	failure_reason	Covers
TV-001-005	15	35	12	true	CT_BELOW_LOWER_LIMIT	AC: CT below lower limit triggers rule
TV-001-006	15	35	14.99	true	CT_BELOW_LOWER_LIMIT	AC: CT just below lower limit triggers rule
TV-001-007	15	35	15	false	null	AC: CT at lower limit passes (boundary)
TV-001-008	15	35	25	false	null	AC: CT within range passes
TV-001-009	15	35	35	false	null	AC: CT at upper limit passes (boundary)
TV-001-010	15	35	35.01	true	CT_ABOVE_UPPER_LIMIT	AC: CT just above upper limit triggers rule
TV-001-011	15	35	38	true	CT_ABOVE_UPPER_LIMIT	AC: CT above upper limit triggers rule

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Decision Table: R-squared Validation

TV	ct_in_range	r2_threshold	calc_r2	triggered	failure_reason	Covers
TV-001-012	true	0.99	0.85	true	POOR_CURVE_FIT	AC: R2 below threshold triggers rule
TV-001-013	true	0.99	0.95	true	POOR_CURVE_FIT	AC: R2 below threshold triggers rule
TV-001-014	true	0.99	0.989	true	POOR_CURVE_FIT	AC: R2 just below threshold triggers rule
TV-001-015	true	0.99	0.99	false	null	AC: R2 at threshold passes (boundary)
TV-001-016	true	0.99	0.995	false	null	AC: R2 above threshold passes
TV-001-017	true	0.99	1.0	false	null	AC: R2 at maximum passes

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Decision Table: R2 Calculation Formula

TV	SS_res	SS_tot	expected_r2	Covers
TV-001-018	0	100	1.0	AC: Perfect fit (R2 = 1 - 0/100 = 1.0)
TV-001-019	1	100	0.99	AC: R2 = 1 - 1/100 = 0.99
TV-001-020	5	100	0.95	AC: R2 = 1 - 5/100 = 0.95

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Decision Table: Quantity Calculation

TV	ct_valid	r2_valid	slope	intercept	ct_value	expected_qty	status	Covers
TV-001-021	true	true	-3.32	40	25	1584.89	PASSED	AC: Qty = 10^((25-40)/-3.32) when both validations pass
TV-001-022	true	true	-3.0	35	20	3162.28	PASSED	AC: Qty = 10^((20-35)/-3.0) = 10^5

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Decision Table: Sequential Validation Flow

TV	has_std_curve	ct_limits	ct_valid	ct_in_range	r2_meets_threshold	final_status	quantity_calculated	Covers
TV-001-023	false	-	-	-	-	NOT_APPLICABLE	false	AC: No std curve config skips rule
TV-001-024	true	missing	-	-	-	ERROR	false	AC: Missing limits logs error
TV-001-025	true	present	false	-	-	ERROR	false	AC: Invalid CT skips validation
TV-001-026	true	present	true	false	-	FAILED	false	AC: CT out of range fails
TV-001-027	true	present	true	true	false	FAILED	false	AC: R2 below threshold fails
TV-001-028	true	present	true	true	true	PASSED	true	AC: All validations pass, quantity calculated

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Test File Locations

Requirement	Test File	Automation Status
REQ-RULES-STDCURVE-001	tests/Unit/Rules/StdqtRuleTest.php	Automated

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Traceability to Existing Tests

Requirement	Jira Tests	Status
REQ-RULES-STDCURVE-001	Pending	Gap

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Gap Analysis

Identified Gaps

Gap	Requirement	Description	Priority	Owner
GAP-001	REQ-RULES-STDCURVE-001	No Jira test ticket for standard curve validation	High	TBD

Remediation Plan

1. GAP-001: Create test ticket covering TV-001-001 through TV-001-028, with emphasis on:
   • Boundary conditions (CT at limits, R2 at threshold)
   • Error handling (missing config, invalid CT)
   • Quantity calculation verification