METADATA
last updated: 2026-03-10_105719
file_name: _archive-combined-files_qms-sops_10k.md
category: guides
subcategory: qms-sops
gfile_url: **FLAGGED - TBD user-facing Google-hosted public file URL**
words: 
tokens: 


CONTENT

# _archive-combined-files_qms-sops_10k (8 files, 9,651 tokens)

# 737  _context-commentary_guides-qms-sops.md
METADATA
last updated: 2026-02-17 RT
file_name: _context-commentary_guides-qms-sops.md
category: guides
subcategory: qms-sops
words: 572
tokens: 737


CONTENT

## Context
The qms-sops subcategory contains seven files that constitute FloodLAMP's formal Quality Management System standard operating procedures for its colorimetric LAMP-based COVID-19 surveillance testing operations. These SOPs were designed as practical, field-ready documents — most were printed and kept in folders or clipboard containers at testing sites for staff to reference during routine testing.

The collection covers the full testing workflow: reagent preparation (SOP-101 for 1X Inactivation Saline Solution, SOP-102 for Reaction Mix), the core amplification assay procedure (SOP-103 Amplification Run Form), training protocols for new operators (SOP-104 Test Training Run Form), quick-reference visual aids (SOP-105-A QuickColor Test Diagrams and SOP-105-B QuickColor Test Signage), and logistics (SOP-030 Shipping Run Form).

The Amplification Run Form (SOP-103) served as the central operational document — the form staff completed for each testing run, which was then scanned to create the Run Form Report (RFR) and entered into a Google Form for record-keeping. The training run form (SOP-104) is the most detailed document in the collection, walking new operators through the complete workflow with specific contamination-control procedures, handling rules, and timing requirements.

Each SOP follows a consistent format with document numbers, effective dates, versioning, and write-in fields for traceability — lot numbers, reagent IDs, operator names, and timestamps. This structure reflected FloodLAMP's approach to maintaining quality documentation while operating under surveillance testing guidance rather than FDA-authorized clinical use.

Related materials can be found in the test-training subcategory (additional training documentation), the test-validation subcategory (assay validation work), and the operations subcategory (broader operational workflows and site management).


## Commentary
These SOPs originated from templates provided by a quality systems consultant. We considered adopting Greenlight Guru, a common quality management software package used in the medical device and diagnostics industry, and worked with a consultant who supported its implementation. Ultimately, I think we wisely decided it was not needed given our size — it would have been overkill for a small operation like ours.

There were primarily two reasons for building a formal QMS. The first was the practical need to understand and control changes to our protocols and files, since we were distributing them to multiple pilot sites. The second was that we applied multiple times for FDA authorization — a process that extended into October 2021, when we received what was our last denial and closure of our submissions. The IRB work and QMS formalization in 2021 were undertaken with the plan of continuing to pursue FDA authorization.

The forms themselves were overall effective in practice. They served their purpose, and we were happy with where they ended up. Most sites used them without complaint or negative feedback. Having the full set of SOPs in place prior to the initial training at a pilot site was helpful. Sites that started with the forms adopted them readily, whereas sites that were already operating when the forms were developed were more reluctant to incorporate them, though I'm not entirely certain about this. One part of the Amplification Run Form that was not frequently used was the lookup map on the second page. These were infrequently used overall and some pilot sites, like Abrome, put participant initials rather than tube IDs into that form. A tool that would have been particularly useful, and this cross-references to the software subcategory, was a way to intake tubes and register their position in the custom tube racks at the same time. This is discussed further in the software context and commentary.


# 592  SOP-030-A_1 Shipping - Run Form.md
METADATA
last updated: 2025-12-15 RT updated metadata after BA fixed inconsistencies
file_name: SOP-030-A_1 Shipping - Run Form.md
file_date: 2022-08-25
title: FloodLAMP QMS SOP-030-A_1 Shipping - Run Form
category: guides
subcategory: qms-sops
tags: operations
source_file_type: gdoc
xfile_type: docx
gfile_url: https://docs.google.com/document/d/1MP7r3NDctnwQJLbl2PKkOQPdX-S789Fw9EvIRoETvnI
xfile_github_download_url: https://raw.githubusercontent.com/FocusOnFoundationsNonprofit/floodlamp-archive/main/guides/qms-sops/SOP-030-A_1%20Shipping%20-%20Run%20Form.docx
pdf_gdrive_url: https://drive.google.com/file/d/1oixE09e0pqHo8uFcBDhzC1OPvf5YzHMT
pdf_github_url: https://github.com/FocusOnFoundationsNonprofit/floodlamp-archive/blob/main/guides/qms-sops/SOP-030-A_1%20Shipping%20-%20Run%20Form.pdf
conversion_input_file_type: docx
conversion: pandoc
license: CC BY 4.0 - https://creativecommons.org/licenses/by/4.0/
tokens: 592
words: 322
notes: 
summary_short: The FloodLAMP QMS SOP-030-A_1 “Shipping - Run Form” is a step-by-step checklist and fill-in template for preparing, labeling, and sending shipments to sites, including inventory/lot and serial tracking and packing list creation. It standardizes the workflow from prep and documentation through carrier label/insurance handling and pickup/dropoff, then follow-up confirmation emails and logging the shipment run.


CONTENT

FloodLAMP Biotechnologies
**Document Number:** SOP-030-A_1
**Effective Date:** 08/25/2022
**Version:** 1

***INTERNAL TITLE:*** Shipping - Run Form

## PREP
- Clean prep table with fresh bleach and ethanol/IPA
- Confirm item list with Manager (description, product ID's, quantities), electronic or paper
- Pick items and enter Lot#/SN's into the Shipping Preparation section of the Inventory tab of Site spreadsheet (can use paper worksheet first)
- Update any modified item info in these columns
- Create Packing List tab for this shipment
(Copy/pasting from Inventory tab)
- Print out Packing Lists (2 versions: Site & Internal)
- With Manager - confirm product ID's and quantities by checking off Internal Packing List
Manager Initials \_\_\_\_\_\_\_\_\_\_\_\_\_
- If any changes, updates are to be made on Inventory tab and then copied to Site Packing List
- Pack checked off items into box
- Put Site Packing List inside box
- Measure box dimensions and weight (record ->)
- When shipment is finalized, copy Ship Qty to Shipping History section of the Inventory tab

## PREP USER WRITE IN
[SOP-030-B_1 Shipping - Log GForm](https://forms.gle/9cGVAe6QAE7yZPFbA)
Date:
Location:

Shipper Name:
Manager Name:

Destination (Site):
Shipment Name:
Shipping Carrier:
Shipping Speed:

Box Dimensions (in):
Box Weight (lbs):
Insurance ($):
Cost ($):
Pickup or Dropoff (circle one)
If Dropoff, Location & Time:

## SHIP
- Create Ship Label in Carrier portal
- Print the Shipping Label
- Cover Ship Label entirely with tape or other clear plastic
- If insured, print 2 copies and leave on front desk for Carrier person to sign
    - Verify Carrier person takes copy and you keep signed copy
- Drop off or wait for pickup as needed (***must request pickup by 2pm***).

## FOLLOWUP
- Email “Ship To Contact” from your support@floodlamp.bio (see “Info” tab of Site spreadsheet), using [Shipping Confirmation Message Template (Ambient)](https://docs.google.com/document/d/1OasH73YK1ID8osBR1rj1gz8mBpQtpkxKnax2Y02Xr2E/edit?usp=sharing)
- Notify FL support staff member for Shipping Confirmation followup:
Name\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Initials\_\_\_\_\_\_\_\_\_\_\_\_\_
- Log this Run Form with Log GForm link


# 457  SOP-101-A_2 1X Inactivation Saline Solution Prep - Table Form.md
METADATA
last updated: 2025-12-14 RT after BA fixed inconsistencies
file_name: SOP-101-A_2 1X Inactivation Saline Solution Prep - Table Form.md
file_date: 2022-08-24
title: FloodLAMP QMS SOP-101-A_2 1X Inactivation Saline Solution Prep - Table Form
category: guides
subcategory: qms-sops
tags: 
source_file_type: gdoc
xfile_type: docx
gfile_url: https://docs.google.com/document/d/1YiosM1yHUjlkwg_aE_j-xyOyT_9hJk_tyT2OU4qDjW8
xfile_github_download_url: https://raw.githubusercontent.com/FocusOnFoundationsNonprofit/floodlamp-archive/main/guides/qms-sops/SOP-101-A_2%201X%20Inactivation%20Saline%20Solution%20Prep%20-%20Table%20Form.docx
pdf_gdrive_url: https://drive.google.com/file/d/1P9W2Zu3esKwstzSynPQJKBlZu_PPjR0S
pdf_github_url: https://github.com/FocusOnFoundationsNonprofit/floodlamp-archive/blob/main/guides/qms-sops/SOP-101-A_2%201X%20Inactivation%20Saline%20Solution%20Prep%20-%20Table%20Form.pdf
conversion_input_file_type: docx
conversion: pandoc
license: CC BY 4.0 - https://creativecommons.org/licenses/by/4.0/
tokens: 457
words: 266
notes: 
summary_short: The FloodLAMP QMS SOP-101-A_2 provides a table-form protocol and log for preparing 1X Inactivation Saline Solution by diluting 100X Inactivation Solution 1:100 into saline with specified vortexing/mixing steps. It includes fields for lot numbers, freeze/thaw and expiration tracking, “put in use” documentation, and a preparation log table capturing volumes and IDs (1X_MMDD-1). The SOP sets the 1X solution expiration at 2 weeks after preparation.


CONTENT

FloodLAMP Biotechnologies
**Document Number:** SOP-101-A_2
**Effective Date:** 08/24/2022
**Version:** 2

***INTERNAL TITLE:*** 1X Inactivation Saline Solution Prep - Table Form
## 100X Inactivation Solution
Lot (-MMDD):
Freeze EXP (MM-YY):
Thaw EXP (+3 months):

## Put New in Use:
Location:
Name:
Date and Time:

Log Link: SOP-101-B_1 {SITE}
Name:
Date and Time:

## 1X Inactivation Saline Solution Prep Protocol:
1\)  Vortex 100X Inactivation Solution for 10 sec.
2\)  Add 1/100 volume of 100X Inactivation Solution to Saline.
3\)  Vortex for 10 sec, Invert 3 times, and Vortex for 10 more sec.
\* If making Inactivation Solution in a bottle, shake instead of vortexing
4\)  Label tube with 1XISS ID (1X\_MMDD-1).
5\)  EXPIRATION of 1X Inactivation Saline Solution: 2 weeks after prep.

| **Name** | **Date + Time** | **1XISS ID**<br>**(1X_MMDD-1)** | **Saline**<br>**Lot + Exp** | **Saline**<br>**mL** | **100XISS**<br>**µL** |
|----------|----------------|-------------------|-------------------|----------------|-----------------|
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# 671  SOP-102-A_2 Reaction Mix Prep - Table Form.md
METADATA
last updated: 2025-12-14 RT after BA fixed inconsistencies
file_name: SOP-102-A_2 Reaction Mix Prep - Table Form.md
file_date: 2022-08-26
title: FloodLAMP QMS SOP-102-A_2 Reaction Mix Prep - Table Form
category: guides
subcategory: qms-sops
tags: 
source_file_type: gdoc
xfile_type: docx
gfile_url: https://docs.google.com/document/d/1Imf8TlrMkjeEpDY0buot0fgfkaJpuJApnaZ7Cm9XbOs
xfile_github_download_url: https://raw.githubusercontent.com/FocusOnFoundationsNonprofit/floodlamp-archive/main/guides/qms-sops/SOP-102-A_2%20Reaction%20Mix%20Prep%20-%20Table%20Form.docx
pdf_gdrive_url: https://drive.google.com/file/d/1ajTg1-lEiXJXvt_bZlWTOeTd41GDQ0Xa
pdf_github_url: https://github.com/FocusOnFoundationsNonprofit/floodlamp-archive/blob/main/guides/qms-sops/SOP-102-A_2%20Reaction%20Mix%20Prep%20-%20Table%20Form.pdf
conversion_input_file_type: docx
conversion: pandoc
license: CC BY 4.0 - https://creativecommons.org/licenses/by/4.0/
tokens: 671
words: 359
notes: 
summary_short: The FloodLAMP QMS SOP-102-A_2 provides a table-form protocol and log for preparing Colorimetric LAMP reaction mix by combining PGS with NEB M1804 CLAMP master mix and dispensing 23 µL per well. It includes “put in use” fields, lot/expiration tracking, reaction mix ID labeling (RM_MMDD-1), and a preparation log capturing tube IDs, number of reactions, and calculated component volumes. The SOP sets reaction mix expiration at 4 weeks after preparation or sooner if discoloration occurs.


CONTENT

FloodLAMP Biotechnologies
**Document Number:** SOP-102-A_2
**Effective Date:** 08/26/2022
**Version:** 2

***INTERNAL TITLE:*** Reaction Mix Prep - Table Form
## Colorimetric LAMP MM - NEB M1804
Lot:
EXP (MM-YY):

## Put New in Use:
Location:
Name:
Date and Time:

Log Link: SOP-102-B_1 {SITE}
Name:
Date and Time:

## Reaction Mix Prep
1\)  Thaw PGS and CLAMP MM
2\)  Vortex PGS and CLAMP MM for 3s, centrifuge/shake down
3\)  Add CLAMP MM to PGS tube (or new 1.5mL tube for custom amount)
4\)  Vortex for 10s and centrifuge/shake down
5\)  Add 23µL of reaction mix per well {at bottom, no blowout, no tip touch}
\* optional use reservoir and multichannel
6\)  Check volumes (look at pink liquid) by lifting plate or strip tubes out of rack
7\)  Label with Reaction Mix ID
8\)  EXPIRATION of Reaction Mix: 4 weeks after prep or if it becomes discolored.

|  |  |  |  |  | 48 24 16 8 | 550 275 183 92 | 655 328 218 109 |
| ----- | ----- | ----- | ----- | ----- | ----- | ----- | ----- |
| **Name** | **Date \+ Time** | **Reaction Mix ID (RM\_MMDD-1)** | **CLAMP MM  TubeID (\_MMDD-X)** | **PGS LOT\# \+ EXP** | **Num Rxns** | **PGS  µL** | **CLAMP MM µL** |
|  |  |  |  |  |  |  |  |
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# 877  SOP-103-A_1 Amplification - Run Form.md
METADATA
last updated: 2025-12-14 RT after BA fixed inconsistencies
file_name: SOP-103-A_1 Amplification - Run Form.md
file_date: 2022-01-22
title: FloodLAMP QMS SOP-103-A_1 Amplification - Run Form
category: guides
subcategory: qms-sops
tags: 
source_file_type: gdoc
xfile_type: docx
gfile_url: https://docs.google.com/document/d/1XFMcUP6L8pzn2crTuWiHZF-UeybzBO64FLrGozo9O3M
xfile_github_download_url: https://raw.githubusercontent.com/FocusOnFoundationsNonprofit/floodlamp-archive/main/guides/qms-sops/SOP-103-A_1%20Amplification%20-%20Run%20Form.docx
pdf_gdrive_url: https://drive.google.com/file/d/1yhaVkXZJYI7PtKd7kGpM0AGN4aA2IPi8
pdf_github_url: https://github.com/FocusOnFoundationsNonprofit/floodlamp-archive/blob/main/guides/qms-sops/SOP-103-A_1%20Amplification%20-%20Run%20Form.pdf
conversion_input_file_type: docx
conversion: pandoc
license: CC BY 4.0 - https://creativecommons.org/licenses/by/4.0/
tokens: 877
words: 473
notes: 
summary_short: The FloodLAMP QMS SOP-103-A_1 is a run form for performing sample inactivation and LAMP amplification, including required PPE, heater setup checks, and step-by-step timing/temperature instructions for water bath or dry heat block inactivation and 65 °C amplification. It provides write-in fields for batch IDs, heater IDs, reagent IDs, control IDs, dispensing method, and run notes to support traceability in the linked site log. The form also includes lookup map tables for recording sample positions in strip tubes or plates.


CONTENT

FloodLAMP Biotechnologies
**Document Number:** SOP-103-A_1
**Effective Date:** 01/22/2022
**Version:** 1

***INTERNAL TITLE:*** Amplification - Run Form
## PREP
Heaters on (Heat indicator lit!)
- 1X Inactivation Saline Soln ready
- Reaction mix strip8/plates ready
- Safety Procedures:
  - lab coat
  - gloves
  - face mask
  - face shield or goggles
- Alcohol wipe sample tubes

## PREP USER WRITE IN
Log Link: SOP-103-B_1 {SITE}
Location:
Name:
Date:
Time:

## INACTIVATION
- Add 1mL of 1X Inactiv Saline Soln to each sample tube
- Vortex 10sec (tubes) or 30sec (rack)
- Water Bath (set 99°C)
  - Heat 8 min then Cool 10 min
- Dry Heat Block (set 95°C)
  - Heat 5 min then Cool 5 min

## INACTIVATION USER WRITE IN
Sample Batch ID (from App):
Inactiv Heater:
1X Inactiv Saline Soln ID:
Dispense: Pipette or Manual Disp or Electric Disp

## AMPLIFICATION REACTION
- Thaw Reaction Mix (if frozen)
- Setup tips to align with reactions
- Add 2μL from each sample tube (pipet up& down 5X, blowout in liquid, tip touch)
- Heat 65°C for 25 min, set timer
- Intake sample tubes in App
- Put sample tubes in fridge
- Remove Reactions and Let cool for 1 min before photo
- Take photo in lightbox
- Crop photo and apply vivid filter
- Update results in App
- Log Run with Form link

## AMPLIFICATION REACTION USER WRITE IN
Amp Heater:
Strip8 Tubes or Plates
Reaction Mix: Frozen or Fresh
Reaction Mix ID:
Num Reactions (including controls):
Pos Ctrl ID:
Neg Ctrl ID (today's 1XISS):
Initial Inconclusives?:
Notes:

## Lookup Map
|         |       |       |       |       |       |       |
|---------|-------|-------|-------|-------|-------|-------|
|         | **1** | **2** | **3** | **4** | **5** | **6** |
| **A 1** |       |       |       |       |       |       |
| **B 2** |       |       |       |       |       |       |
| **C 3** |       |       |       |       |       |       |
| **D 4** |       |       |       |       |       |       |
| **E 5** |       |       |       |       |       |       |
| **F 6** |       |       |       |       |       |       |
| **G 7** |       |       |       |       |       |       |
| **H 8** |       |       |       |       |       |       |
||

|         |       |       |       |        |        |        |
|---------|-------|-------|-------|--------|--------|--------|
|         | **7** | **8** | **9** | **10** | **11** | **12** |
| **A 1** |       |       |       |        |        |        |
| **B 2** |       |       |       |        |        |        |
| **C 3** |       |       |       |        |        |        |
| **D 4** |       |       |       |        |        |        |
| **E 5** |       |       |       |        |        |        |
| **F 6** |       |       |       |        |        |        |
| **G 7** |       |       |       |        |        |        |
| **H 8** |       |       |       |        |        |        |
||


# 1,719  SOP-104-A_1 Test Training - Run Form.md
METADATA
last updated: 2025-12-14 RT after BA fixed inconsistencies
file_name: SOP-104-A_1 Test Training - Run Form.md
file_date: 2022-08-26
title: FloodLAMP QMS SOP-104-A_1 Test Training - Run Form
category: guides
subcategory: qms-sops
tags: 
source_file_type: gdoc
xfile_type: docx
gfile_url: https://docs.google.com/document/d/1Nk586b_UbYKr6iE7Yrhe7NHN1tl4qSttFPYquUHJQJQ
xfile_github_download_url: https://raw.githubusercontent.com/FocusOnFoundationsNonprofit/floodlamp-archive/main/guides/qms-sops/SOP-104-A_1%20Test%20Training%20-%20Run%20Form.docx
pdf_gdrive_url: https://drive.google.com/file/d/1JmcisdqvDVhxCmCFEHRi3YacFW9xYaBB
pdf_github_url: https://github.com/FocusOnFoundationsNonprofit/floodlamp-archive/blob/main/guides/qms-sops/SOP-104-A_1%20Test%20Training%20-%20Run%20Form.pdf
conversion_input_file_type: docx
conversion: pandoc
license: CC BY 4.0 - https://creativecommons.org/licenses/by/4.0/
tokens: 1719
words: 1021
notes: 
summary_short: The FloodLAMP QMS SOP-104-A_1 is an amplification training run form that walks trainees through contamination-control practices, 1XISS preparation, sample inactivation, reaction mix preparation, and the 25-minute LAMP amplification workflow. It includes a checklist-style procedure with specific handling rules (e.g., glove changes, control addition order, timing, and imaging settings) to prevent post-amplification contamination. The form provides write-in fields for batch/heater/reagent/control IDs and lookup tables for tracking sample positions in strip tubes or plates.


CONTENT

FloodLAMP Biotechnologies
**Document Number:** SOP-104-A_1
**Effective Date:** 08/26/2022
**Version:** 1

***INTERNAL TITLE:*** Amplification Training - Run Form
## PREP
 - Pen & sharpie labeled with green tape
 - Separation of Post-Amp area
 - Heaters on (Heat indicator lit!)
 - Safety Procedures:
   - lab coat
   - gloves
   - face mask
   - face shield or goggles
 - Alcohol wipe sample tubes

## PREP USER WRITE IN
Log Link: SOP-104-B_1 {SITE}
Location:
Name:
Date:
Time:

## CONTAMINATION INFRACTIONS
-   PPE lapse/removal
-   Use green labeled pen/marker with bare hands and not putting it to be cleaned afterwards
-   Use unmarked pen/marker with clean gloves (without cleaning gloves after or changing gloves)
-   Bare hands on anything improper, except in desk area
-   Reuse pipette tip improperly
-   Touch pipette tip to anything and then not discard it
-   Touch anything dirty then go back to work (face, mask, uncleaned phone, uncleaned laptop)

## NOTE
It is recommended that 1XISS and Reaction Mix be prepared before the assay run (instructions below).

## DOCUMENTATION
-   Check off each item after completing it
-   Write legibly

## GLOSSARY OF TERMS
**100XIS**………………………….. 100-fold concentrated Inactivation Solution
**1XISS**……………………………. 1X Inactivation Saline Solution
**PGS**………………………………. Primer Guanidine Solution
**CLAMP MM**…………………. Colorimetric Loop-Mediated Isothermal Amplification Master Mix
**RM**………………………………… Reaction Mix (CLAMP MM and PGS)
**TPC**………………………………. Twist Positive Control

## 1XISS PREP
 - Record volumes of saline & 100XIS in 1XISS Prep form prior to pipetting
 - Combine saline and 100XIS in a 50mL falcon tube or 30mL Chub tube, depending on volume
 - Vortex 30 seconds
 - Label tube with 1XISS ID (e.g., "1X_MMDD-1") and record the same ID into the 1XISS Prep Form and the table on this form

## 1XISS PREP USER WRITE IN
Sample Batch ID (from App):
Inactiv Heater:
1X Inactiv Saline Soln ID:
Dispense: Pipette or Manual Disp or Electric Disp

## INACTIVATION
-   Add 1mL of 1XISS to each sample tube
-   Verify that tubes are properly sealed afterward (i.e., not cross-threaded)
-   Vortex 10 sec (if individual tubes) or 30 sec (if tubes-in-rack)
-   Heat 8 min in Water Bath (set to 99°C)
-   Cool 10 min
-   Put in refrigerator before 30 minute mark

## REACTION MIX PREP
-   Complete the entry in the RM Prep Form prior to pipetting
-   Calc volumes correctly for PGS and CLAMP based on number of reactions
-   Remove CLAMP MM and PGS from freezer to thaw, but do not allow them to warm
-   Briefly spin down reagent tubes (removes reagent from the cap and tube walls)
-   Pipette CLAMP MM and PGS into a 1.5mL tube using calculated volumes
-   Promptly return PGS and CLAMP source tubes to freezer
-   Vortex and spin down the RM tube
-   Aliquot 23uL of RM into each reaction tube (plate or strips-of-8)
    -   Pipetting at the bottom of tubes

    -   No blowout while dispensing reaction mix (to prevent bubbles in bottom of well)
-   Visually check the volumes in each reaction tube (that they appear to be even)
-   If using a plate, cover filled tubes with rack lid to prevent dust
-   At this stage, RM reaction tubes can be capped and placed in the freezer for storage if they are not to be used fresh.

## AMPLIFICATION REACTION
- Remove PCR cold block from freezer ~10 min before adding tubes
- Prep RM plate/strips (thawed, not warm)
- Set up tips to align with reactions
- Use a lookup rack to keep track of sample order
  - Tip layout aligns with arrangement of sample tubes in lookup rack & aligns with layout of reaction plate/strips
- Add negative control first (2uL 1XISS)
- Add 2uL of each inactivated sample to reaction tubes, visually checking the volume in the tip each time. Pipette up & down 5X, blow out in liquid, tip touch.
- With each add, verify the correct position (tip vs sample tube vs reaction tube)
- Transfer plate/strip to PCR rack (not cold block - rxns don't go to amp cold)
- Retrieve TPC from freezer, touching only with one hand (consider this hand dirty)
- Add 2uL TPC to pos. ctrl, return TPC to freezer (IMMEDIATELY change glove)
- Cap reaction tubes / seal plate
- Change gloves again after loading tubes/plate onto amp heater
- Set main timer for 25 min
- Set secondary timer for 24 min
- Put sample tubes in fridge
- Remove rxns from amp promptly, wait 1 minute before imaging
- Take photo in lightbox
- For photo apply crop and 'Vivid' filter (or increase saturation 70% for android)
- Log amp run sheet with QR code
- On app: Intake, Process and Result tubes

## AMPLIFICATION REACTION USER WRITE IN
Amp Heater:  
Strip8 Tubes or Plates  
Reaction Mix: Frozen or Fresh  
Reaction Mix ID:  
Num Reactions (including controls):  
Pos Ctrl ID:  
Neg Ctrl ID (today's 1XISS):  
Initial Inconclusives?:  
Notes:

|         |       |       |       |       |       |       |
|---------|-------|-------|-------|-------|-------|-------|
|         | **1** | **2** | **3** | **4** | **5** | **6** |
| **A 1** |       |       |       |       |       |       |
| **B 2** |       |       |       |       |       |       |
| **C 3** |       |       |       |       |       |       |
| **D 4** |       |       |       |       |       |       |
| **E 5** |       |       |       |       |       |       |
| **F 6** |       |       |       |       |       |       |
| **G 7** |       |       |       |       |       |       |
| **H 8** |       |       |       |       |       |       |
||

|         |       |       |       |        |        |        |
|---------|-------|-------|-------|--------|--------|--------|
|         | **7** | **8** | **9** | **10** | **11** | **12** |
| **A 1** |       |       |       |        |        |        |
| **B 2** |       |       |       |        |        |        |
| **C 3** |       |       |       |        |        |        |
| **D 4** |       |       |       |        |        |        |
| **E 5** |       |       |       |        |        |        |
| **F 6** |       |       |       |        |        |        |
| **G 7** |       |       |       |        |        |        |
| **H 8** |       |       |       |        |        |        |
||


# 632  SOP-105-A_1 QuickColor Test Diagrams.md
METADATA
last updated: 2025-12-14 RT
file_name: SOP-105-A_1 QuickColor Test Diagrams.md
file_date: 2022-08-26
title: FloodLAMP QMS SOP-105-A_1 QuickColor Test Diagrams
category: guides
subcategory: qms-sops
tags: 
source_file_type: gdoc
xfile_type: docx
gfile_url: https://docs.google.com/document/d/15oCAL2T0or_BigVAw1kpXS_BojPpcPsMOw8aJ_qw5mA
xfile_github_download_url: https://raw.githubusercontent.com/FocusOnFoundationsNonprofit/floodlamp-archive/main/guides/qms-sops/SOP-105-A_1%20QuickColor%20Test%20Diagrams.docx
pdf_gdrive_url: https://drive.google.com/file/d/1hgxWFnT6RCJRAA6CyJWD1lnAr_5P1vNT
pdf_github_url: https://github.com/FocusOnFoundationsNonprofit/floodlamp-archive/blob/main/guides/qms-sops/SOP-105-A_1%20QuickColor%20Test%20Diagrams.pdf
conversion_input_file_type: docx
conversion: pandoc
license: CC BY 4.0 - https://creativecommons.org/licenses/by/4.0/
tokens: 632
words: 304
notes: 
summary_short: The FloodLAMP QMS SOP-105-A_1 QuickColor Test Diagrams provides step-by-step diagrams for running the FloodLAMP QuickColor COVID-19 pooled saliva test, covering inactivation solution preparation, reaction mix formulation, sample processing, and colorimetric amplification readout. It serves as a visual bench reference for lab technicians performing the assay.


CONTENT

FloodLAMP Biotechnologies
**Document Number:** SOP-105-A_1
**Effective Date:** 08/26/2022
**Version:** 1

***INTERNAL TITLE:*** QuickColor Test Diagrams
Print Format

## FloodLAMP QuickColor COVID-19 Test Flow
_Description based on Diagram_
1\)	**Inactivation solution (prepare)**
  - Combine:
    - Saline
    - 100X Inactivation Solution
  - Apply to: Pooled dry swab samples
  - Heat treatment:
    - 95 °C
      - 5 mL: 8 min
      - 1.5 mL: 5 min
  - Cool down:
    - Let cool
      - 5 mL: 10 min
      - 1.5 mL: 5 min

2\)	**Reaction mix (prepare)**
  - Combine:
    - Primer solution
    - Color LAMP Master Mix

3\)	**Run reaction**
  - Add processed samples to reaction mix
  - Incubate:
    - 65 °C for 25 min


## FloodLAMP QuickColor COVID-19 Test Diagram
_Description based on Diagram_

1\) Make 1X Inactivation Saline Solution  
- **Add 100X Inactivation Solution to 0.9% Saline**

|  |  |
|:----------------------------:|:------------------------:|
| **100X Isol. Saline**<br>**500 µL** | **0.9% Saline**<br>**50 mL** |
||

_Result: 1X Inactivation Saline Solution (~50 mL)_

---

2\) Elute Pooled Dry Swab Samples  
- **Add 1,000 µL of 1X Inactivation Saline Solution to pooled dry swab samples**  
_Result: Eluted sample (1,000 µL)_

---

3\) Heat Inactivate & Cool  
- **Heat at 95°C for 8 min**  
- **Cool at room temperature for 10 min**

---

4\) Make Reaction Mix (CLAMP Reaction Mix)  
- **In a 1.5 mL tube, combine:**

|  |  |  |  |  |
|:----------:|:---------:|:----------:|:----------:|:----------:|
| **Reactions** | **8** | **16** | **24** | **48** |
| **PGS (µL)** | 92 | 183 | 275 | 550 |
| **LAMP MM (µL)** | 109 | 218 | 328 | 655 |
||

---

5\) Set Up Reactions  
- **Dispense 23 µL reaction mix per tube (well)**
- **Add 2 µL sample**
- **Include Positive and Negative controls**

---

6\) Amplify & Read  
- **Heat at 65°C for 25 min**
- _Output: Results (colorimetric readout)_


# 679  SOP-105-B_1 QuickColor Test Signage.md
METADATA
last updated: 2025-12-14 RT after BA fixed inconsistencies
file_name: SOP-105-B_1 QuickColor Test Signage.md
file_date: 2022-08-26
title: FloodLAMP QMS SOP-105-B_1 QuickColor Test Signage
category: guides
subcategory: qms-sops
tags: 
source_file_type: gdoc
xfile_type: docx
gfile_url: https://docs.google.com/document/d/1IO3MjHxGCzMMlYJsnHvZyzYv-ohpRolbGJksY8S08-E
xfile_github_download_url: https://raw.githubusercontent.com/FocusOnFoundationsNonprofit/floodlamp-archive/main/guides/qms-sops/SOP-105-B_1%20QuickColor%20Test%20Signage.docx
pdf_gdrive_url: https://drive.google.com/file/d/1RR_V3e6fn0g7xCESHnX3t-6VYQi3r1NU
pdf_github_url: https://github.com/FocusOnFoundationsNonprofit/floodlamp-archive/blob/main/guides/qms-sops/SOP-105-B_1%20QuickColor%20Test%20Signage.pdf
conversion_input_file_type: docx
conversion: pandoc
license: CC BY 4.0 - https://creativecommons.org/licenses/by/4.0/
tokens: 679
words: 309
notes: 
summary_short: The FloodLAMP QMS SOP-105-B_1 QuickColor Test Signage is a print-ready, step-by-step bench guide for running the QuickColor assay from sample intake through reporting results. It summarizes key workflow actions and parameters, including 1XISS dilution ratios, inactivation heating/cooling times for water bath or dry heat block, reaction mix component volumes for common reaction counts, and 65 °C amplification timing. The signage also highlights contamination-control reminders (cleaning tubes, one tube open at a time) and imaging/logging instructions for reporting.


CONTENT

FloodLAMP Biotechnologies
**Document Number:** SOP-105-B_1
**Effective Date:** 08/26/2022
**Version:** 1

***INTERNAL TITLE:*** QuickColor Test Signage

Print Format

1\) Intake Sample Tubes
---
- **Clean tubes - spray wipe with ethanol/alcohol and wipe tubes**
- **Intake with App (can also do during Amp heating)**

2\) Make 1X Inactivation Saline Solution
---
-   **Add 100X Inactivation Solution to Saline**

|  |  |  |
|:----------------------:|:-----------------------:|:-----------------------:|
| **Saline**<br>**5 mL** | **Saline**<br>**15 mL** | **Saline**<br>**50 mL** |
| **100X IS**<br>**50 μL** | **100X IS**<br>**150 μL** | **100X IS**<br>**500 μL** |
||

3\) Add 1X Inactivation Saline Solution to Sample Tubes
---
-   **Add 1mL of inactivation saline solution (1XISS) to each sample tube**
-   **One sample tube open at a time**

4\) Heat to Inactivate Samples
---
-   **Water Bath (set at 99°C)**
**Heat 8 mintues**
**Cool 10 minutes**
-   **Dry Heat Block for 1.5mL sample tubes (set at 95°C)**
**Heat 5 mintues**
**Cool 5 minutes**

5\) Make Reaction Mix
---
-   **Add CLAMP MM and Primer Soln (PGS) to 1.5mL tube**
-   **Aliquot into Strip8 tubes or 96 well PCR Plate**

|  |  |  |  |
|:--------:|:--------:|:--------:|:--------:|
| **8 Rxns** | **16 Rxns** | **24 Rxns** | **48 Rxns** |
| **PGS**<br>**92 μL** | **PGS**<br>**183 μL** | **PGS**<br>**275 μL** | **PGS**<br>**550 μL** |
| **CLAMP MM**<br>**109 μL** | **CLAMP MM**<br>**218 μL** | **CLAMP MM**<br>**328 μL** | **CLAMP MM**<br>**655 μL** |
||

6\) Add Sample to Reaction
---
-   **Add 2μL from each sample tube to corresponding well**
-   **Pipet up and down 5 times, blowout in liquid, tip touch**

7\) Heat Amp Reactions
---
-   **Heat at 65ºC for 25 min**
-   **Set personal timer (on phone) for 24 min**

8\) Log and Report Results
---
-   **Let samples cool for at least 1 minute before taking photo**
-   **Crop and apply vivid filter**
-   **Log Amp Run Form with QR code link**