STD: Qualitative Reporting Rule (RQUAL)

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

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Overview

This document specifies tests for the Qualitative Reporting (RQUAL) rule using decision tables and test vectors. The rule determines qualitative reporting outcomes (Detected/Not Detected) by comparing sample CT values against configured cutoff thresholds, with support for specimen-type-specific configurations.

Rule Characteristics:

• Pure business logic (no UI)
• CT threshold comparison (CT < CutOff = Detected, CT >= CutOff = Not Detected)
• Specimen-type-specific configuration selection when enabled
• Last-modified fallback when sample type mode disabled

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-RQUAL-001	Qualitative Threshold Evaluation	6	8	100%	None
REQ-RULES-RQUAL-002	Specimen-Specific Configuration Selection	8	10	100%	None

Totals: 2 REQs, 14 Conditions, 18 Test Vectors, 100% Coverage

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REQ-RULES-RQUAL-001: Qualitative Threshold Evaluation

Input Variables

Variable	Type	Valid Values	Description
sample.ct	float	numeric (positive)	Sample CT (cycle threshold) value
config.upper_boundary	float	numeric (positive)	CutOff threshold from reporting configuration
sample.reporting_type	string	Qualitative, Quantitative	Sample reporting configuration

Output Variables

Variable	Type	Description
outcome	string	Detected, Not Detected, Error
rule_applied	bool	Whether RQUAL rule was executed

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Decision Table: CT vs CutOff Comparison

TV	sample.ct	config.upper_boundary	outcome	Covers
TV-001-001	25	30	Detected	AC: CT < CutOff = Detected (low CT = strong signal)
TV-001-002	30	30	Not Detected	AC: CT >= CutOff = Not Detected (boundary)
TV-001-003	35	30	Not Detected	AC: CT >= CutOff = Not Detected
TV-001-004	10	10	Not Detected	AC: CT >= CutOff at minimum boundary
TV-001-005	9.99	10	Detected	AC: CT < CutOff = Detected (just below boundary)
TV-001-006	0.5	30	Detected	AC: Very low CT value = strong signal = Detected

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Decision Table: Rule Scope Filter

TV	sample.reporting_type	rule_applied	Covers
TV-001-007	Qualitative	true	AC: Rule applied to qualitative samples
TV-001-008	Quantitative	false	AC: Rule skipped for quantitative samples

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REQ-RULES-RQUAL-002: Specimen-Specific Configuration Selection

Input Variables

Variable	Type	Valid Values	Description
setting.use_sample_type	bool	true, false	System setting for specimen-type matching
sample.specimen_type	string	Plasma, Serum, ...	Sample specimen type
sample.mix	string	identifier	Sample mix identifier
sample.target	string	identifier	Sample target identifier
configs[]	array	reporting configurations	Available reporting configurations
config.specimen_type	string	Plasma, Serum, ...	Configuration specimen type
config.last_modified	datetime	timestamp	Configuration modification timestamp
config.upper_boundary	float	numeric	CutOff threshold

Output Variables

Variable	Type	Description
selected_config	object	The reporting configuration used for evaluation
outcome	string	Detected, Not Detected based on selected config

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Decision Table: Sample Type Mode Enabled

TV	use_sample_type	sample.specimen	sample.ct	plasma.upper_boundary	serum.upper_boundary	selected_config	outcome	Covers
TV-002-001	true	Plasma	25	30	10	Plasma	Detected	AC: Match specimen to config (CT 25 < Plasma cutoff 30 = Detected)
TV-002-002	true	Serum	25	30	10	Serum	Not Detected	AC: Match specimen to config (CT 25 >= Serum cutoff 10 = Not Detected)
TV-002-003	true	Plasma	35	30	10	Plasma	Not Detected	AC: Plasma specimen CT >= cutoff = Not Detected
TV-002-004	true	Serum	5	30	10	Serum	Detected	AC: Serum specimen CT < cutoff = Detected

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Decision Table: Sample Type Mode Disabled (Last Modified Fallback)

TV	use_sample_type	sample.specimen	sample.ct	plasma.last_mod	serum.last_mod	serum.upper_boundary	selected_config	outcome	Covers
TV-002-005	false	Plasma	25	2023-11-08 00:00	2023-11-08 00:01	10	Serum (last mod)	Not Detected	AC: Uses most recent config (CT 25 >= cutoff 10 = Not Detected)
TV-002-006	false	Serum	25	2023-11-08 00:00	2023-11-08 00:01	10	Serum (last mod)	Not Detected	AC: Uses most recent config regardless of specimen (CT 25 >= 10)
TV-002-007	false	Plasma	5	2023-11-08 00:00	2023-11-08 00:01	10	Serum (last mod)	Detected	AC: Last modified fallback, CT < cutoff = Detected

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Decision Table: Configuration Match by Mix/Target/Specimen

TV	sample.mix	sample.target	sample.specimen	config.mix	config.target	config.specimen	match	Covers
TV-002-008	HEV	HEV	Plasma	HEV	HEV	Plasma	true	AC: Full match on Mix, Target, Specimen
TV-002-009	HEV	HEV	Plasma	HEV	HEV	Serum	false	AC: Specimen mismatch
TV-002-010	HEV	HAV	Plasma	HEV	HEV	Plasma	false	AC: Target mismatch

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Error Handling

Decision Table: Configuration Errors

TV	Condition	Expected Behavior	Covers
TV-ERR-001	No matching reporting config for specimen type	Fall through to subsequent rules or raise configuration error	AC: Error handling - missing config
TV-ERR-002	Sample type mode enabled, no specimen type match	Use fallback selection logic	AC: Error handling - no specimen match

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Traceability to Existing Tests

Requirement	SRS Test Cases	Jira	Status
REQ-RULES-RQUAL-001	TV-001-001 to TV-001-008	BT-5241	Partial
REQ-RULES-RQUAL-002	TC-RQUAL-002-01, TC-RQUAL-002-02	BT-5204, BT-5191	Partial

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Gap Analysis

Identified Gaps

Gap	Requirement	Description	Priority	Automation Status
GAP-001	REQ-RULES-RQUAL-001	No dedicated test cases for core CT threshold comparison	High	Automated

Remediation Plan

1. GAP-001: Create test coverage for TV-001-001 through TV-001-008 covering:
   • CT < CutOff boundary conditions
   • CT >= CutOff boundary conditions
   • Rule scope filter (qualitative vs quantitative samples)

Existing Coverage

REQ-RULES-RQUAL-002 has existing test cases (TC-RQUAL-002-01, TC-RQUAL-002-02) documented in the SRS that cover specimen-type-specific configuration selection with sample type mode enabled and disabled scenarios.

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Test Data Reference

Standard Test Configuration

Based on SRS example configuration:

Reportings:

Config Name	Mix	Target	Specimen Type	Upper Boundary	Last Modified
Plasma Config	HEV	HEV	Plasma	30	2023-11-08 00:00:00
Serum Config	HEV	HEV	Serum	10	2023-11-08 00:01:00

Rule Mappings:

Mix	Target	Specimen Type	Rule
HEV	HEV	Plasma	RQUAL
HEV	HEV	Serum	RQUAL