STD: Reporting Quant as Qual Rule (RQUANTASQUAL)

Version: v1.0.0 Status: Draft SRS Source: docusaurus/docs/srs/rules/rule-reporting-quant-as-qual.md Rule Name: RQUANTASQUAL Domain: RULES-RQUANTQUAL

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Overview

This document specifies tests for the Reporting Quant as Qual rule using decision tables and test vectors. The rule converts quantitative PCR results (CT/Quantity values) into qualitative outcomes (Detected/Not Detected) by comparing against configured Limit of Detection (LoD) thresholds.

Rule Characteristics:

• Pure business logic (no UI)
• Threshold comparison (inclusive boundary)
• Specimen-type-based threshold selection (when enabled)
• Fallback to last-modified reporting configuration (when specimen matching disabled)

Test Method: TM-API (per Test Plan §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-RQUANTQUAL-001	Qualitative Outcome Determination	4	6	100%	None
REQ-RULES-RQUANTQUAL-002	Specimen-Based Threshold Selection	6	10	100%	None

Totals: 2 REQs, 10 Conditions, 16 Test Vectors, 100% Coverage

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REQ-RULES-RQUANTQUAL-001: Qualitative Outcome Determination

Input Variables

Variable	Type	Valid Values	Description
obs.quantity	float	≥ 0	Measured quantity from PCR analysis
obs.ct_value	float	> 0	Measured CT (cycle threshold) value
config.lod_threshold	float	> 0	Configured Limit of Detection (upper boundary)

Output Variables

Variable	Type	Description
well.outcome	string	Qualitative result: "Detected" or "Not Detected"

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Decision Table: Threshold Comparison

Tests the core quant-as-qual conversion logic. The LoD boundary is inclusive (>= yields Detected).

TV	obs.quantity	config.lod_threshold	expected_outcome	Covers
TV-001-001	100	50	Detected	AC: Quantity above threshold
TV-001-002	50	50	Detected	AC: Quantity at threshold (boundary inclusive)
TV-001-003	30	50	Not Detected	AC: Quantity below threshold

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Decision Table: CT Value Boundary

Tests boundary behavior using CT values at the LoD threshold.

TV	obs.ct_value	config.lod_threshold	expected_outcome	Covers
TV-001-004	25	30	Detected	AC: CT below threshold (lower CT = higher quantity)
TV-001-005	30	30	Detected	AC: CT at boundary (inclusive)
TV-001-006	35	30	Not Detected	AC: CT above threshold (higher CT = lower quantity)

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REQ-RULES-RQUANTQUAL-002: Specimen-Based Threshold Selection

Input Variables

Variable	Type	Valid Values	Description
config.use_sample_type	bool	true, false	Enable specimen-type-specific threshold selection
well.specimen_type	string	Plasma, Serum, ...	Sample matrix category
reporting.specimen_type	string	Plasma, Serum, ...	Reporting configuration specimen type
reporting.lod_threshold	float	> 0	LoD threshold for the reporting configuration
reporting.last_modified	timestamp	datetime	Last modification timestamp of reporting config

Output Variables

Variable	Type	Description
selected_lod	float	The LoD threshold selected for comparison
well.outcome	string	Qualitative result based on selected threshold

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Decision Table: Specimen Type Enabled

When use_sample_type is enabled, the system selects the LoD threshold matching the well's specimen type.

TV	use_sample_type	well.specimen	plasma_lod	serum_lod	obs.ct	expected_lod	expected_outcome	Covers
TV-002-001	true	Plasma	30	10	25	30	Not Detected	AC: Plasma well uses Plasma LoD (25 < 30)
TV-002-002	true	Serum	30	10	25	10	Detected	AC: Serum well uses Serum LoD (25 >= 10)
TV-002-003	true	Plasma	30	10	35	30	Not Detected	AC: CT above Plasma threshold
TV-002-004	true	Serum	30	10	5	10	Detected	AC: CT well below Serum threshold

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Decision Table: Specimen Type Disabled (Legacy Mode)

When use_sample_type is disabled, the system uses the last-modified reporting configuration regardless of specimen type.

TV	use_sample_type	plasma_last_mod	serum_last_mod	well.specimen	obs.ct	expected_lod	expected_outcome	Covers
TV-002-005	false	2023-11-08 00:00:00	2023-11-08 00:01:00	Plasma	25	10 (Serum)	Detected	AC: Uses last modified (Serum newer)
TV-002-006	false	2023-11-08 00:01:00	2023-11-08 00:00:00	Serum	25	30 (Plasma)	Not Detected	AC: Uses last modified (Plasma newer)

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Decision Table: All Wells Same Threshold (Disabled Mode)

When sample type is disabled, all wells in the same run use the same LoD threshold.

TV	use_sample_type	last_mod_lod	well_A.specimen	well_B.specimen	obs.ct	well_A_outcome	well_B_outcome	Covers
TV-002-007	false	10	Plasma	Serum	25	Detected	Detected	AC: Same threshold for all wells
TV-002-008	false	30	Plasma	Serum	25	Not Detected	Not Detected	AC: Uniform threshold application

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Decision Table: Rule Mapping Requirement

Specimen-based threshold selection requires rule mappings to be configured per specimen type.

TV	use_sample_type	plasma_mapping	serum_mapping	well.specimen	rule_applies	Covers
TV-002-009	true	configured	configured	Plasma	true	AC: Rule mapping exists
TV-002-010	true	configured	missing	Serum	false	AC: Rule mapping required per specimen

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Traceability to Existing Tests

Requirement	Jira Tests	Automation Status
REQ-RULES-RQUANTQUAL-001	BT-5204	Automated (3 TVs)
REQ-RULES-RQUANTQUAL-002	BT-4283	Manual

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Gap Analysis

Identified Gaps

Gap	Requirement	Description	Priority	Owner
None	-	All acceptance criteria have corresponding test vectors	-	-

Coverage Notes

1. REQ-RULES-RQUANTQUAL-001: Core threshold comparison is fully covered by TV-001-001 through TV-001-006, including boundary conditions.

2. REQ-RULES-RQUANTQUAL-002: Specimen-based selection is covered by:

   • Enabled mode scenarios (TV-002-001 through TV-002-004)
   • Disabled/legacy mode scenarios (TV-002-005 through TV-002-008)
   • Rule mapping requirement (TV-002-009, TV-002-010)