Laboratory Method References

Domestic NSSP Laboratory List

Method NSSP Status Target/Matrix/Limitations Application (Purpose of Method) Reference Checklist Links
Approved Methods for Microbiological Testing   
APHA Decimal Dilution Approved Total Coliforms and Fecal Coliforms  - G.A. waters and Shellfish Growing Area Classification Recommended Procedures, APHA 1970 Microbiology
12 tube Single Dilution Approved Total Coliforms and Fecal Coliforms  - G.A. waters (cannot be used with Systematic Random Sampling) and Shellfish (end product depurated shellfish only) Growing Area Classification and Depuration Redman 1974, Proceedings of  8th National Shellfish Sanitation Workshop (J. Springer)  NSSP Interpretation 17-IV-@.02-102 Microbiology
Other APHA (10 tube, 10 ml portions) Approved Total Coliforms - UV Treated Process water Wet Storage and Depuration Standard Methods, 18th edition, 1992 Section 9221 Microbiology
mEndo agar LES Approved Total Coliforms - UV Treated Process water Wet Storage and Depuration Standard Methods, 20th edition, 1998. Section 9222 B. ; Proposal 11-111 Microbiology
A-1M Decimal Dilution MPN  Approved Fecal Coliforms - G.A. waters Growing Area Classification Method 978.23, AOAC 1990 Microbiology
A-1M 12 tube Single Dilution MPN Approved Fecal Coliforms - G.A. waters (cannot be used with Systematic Random Sampling) Growing Area Classification Method 978.23, AOAC 1990; NSSP Interpretation 17-III-@.02-100  Microbiology
A-1M without salicin  Approved Fecal Coliforms - G.A. waters (requires comparability testing) Growing Area Classification Karolus et. al 2003   Microbiology
mTEC Approved Fecal Coliforms - G.A. waters Growing Area Classification Rippey et. al 1987 (grandfathered)

Microbiology

ETCP Approved Fecal Coliforms - Shellfish (Clams only) Depuration Cabelli and Heffernan 1970 Microbiology
Standard Plate Count Approved Total Bacteria - Shellfish Shellfish transportation and handling  Recommended Procedures, APHA 1970 Microbiology
Approved Limited Use Methods for Microbiological Testing   
Modified Double Agar Overlay (MSC) Approved Limited Use MSC -  Shellfish (Hard and Soft Clams and Oysters) Tracking tool for point-sources; est. buffer zones around WWTP; reopen after WWTP discharge; assess before/after relay SLV (2009; Proposal 09-114 [soft shelled clams and oyster];13-120 [hard clams])   Microbiology
Approved Methods for Vibrio Enumeration  
EIA Approved Vibrio vulnificus (Vv) - Shellfish Antibody no longer available Reference no longer available (FDA BAM 1992) Under Development
Vibrio MPN ( with PCR confirmation) Approved Vibrio parahaemolyticus (Vp) - Shellfish PHP FDA BAM Ch9  Under Development
Direct Plating Method (probe) Approved Vibrio parahaemolyticus (Vp) (tlh & tdh) - Shellfish Growing Area Reopening  FDA BAM Ch 9; Cook et. al 1999 Checklist Under Interim Approval (17-110)
Vibrio MPN (with biochem or probe confirmation) Approved Vibrio vulnificus (Vv) - Shellfish PHP FDA BAM Ch9 & SLVs & Wright et. al 1993 Under Development
Vibrio MPN (with biochem or probe confirmation) Approved Vibrio parahaemolyticus (Vp) - Shellfish PHP FDA BAM Ch9 & SLVs & McCarthy et. al 1999 Under Development
SYBR Green 1 QPCR-MPN  Approved Vibrio vulnificus (Vv) - Oysters PHP  SLV (2009; Proposal 09-103) Under Development
MPN- Real Time PCR Approved Vibrio parahaemolyticus (Vp) (tdh & trh) - Oysters PHP and/or Growing Area Reopening SLV (2015; Proposal 15-111); Kinsey et al. 2015 PCR Microbiology
MPN- Real Time PCR Approved Vibrio parahaemolyticus (Vp) (tlh) - Oysters PHP and/or Growing Area Reopening SLV (2015; Proposal 15-113); Kinsey et al. 2015 PCR Microbiology
MPN - Real Time PCR Approved Vibrio vulnificus (Vv) - Oysters PHP SLV (2019; Proposal 19-126); Kinsey et al. 2015 Under Development
Approved Methods for Marine Biotoxin Testing  
APHA Mouse Bioassay (MBA) Approved PSP and NSP - Shellfish Growing Area Management Recommended Procedures, APHA 1970  MBA/Scotia/PSP, MBA/NSP
Receptor Binding Assay (RBA) Approved PSP - Shellfish (Mussels only) Growing Area Management SLV (2013; Proposal 13-114) Checklist Under Review (19-141)
PCOX Approved PSP - Shellfish (mussels, clams, oysters, scallops) Growing Area Management Proposal 09-104Rourke et. al 2008; Proposal 15-108 PSP/PCOX
LC MS/MS Approved  DSP - clams only Growing Area Management SLV (2017; Proposal 17-103) Checklist under Interim Approval(19-136)
Domoic Acid HPLC Approved  ASP (Domoic Acid) - Shellfish Growing Area Management  Quilliam et. al 1991 Domoic/HPLC
Approved Limited Use Methods for Marine Biotoxin Testing  
Abraxis Shipboard ELISA Approved Limited Use PSP - Shellfish (surf clams and quahogs) Growing Area Management  SLV 05-111 (extraction) & 09-107 (ELISA) Under Development
Scotia Rapid Test Approved Limited Use PSP - Shellfish screen Growing Area Management Proposal 03-116 and 05-110 MBA/Scotia/PSP
Reveal 2.0 ASP Approved Limited Use ASP (Domoic Acid) - Shellfish screen Growing Area Management SLV (2013; Proposal 13-112) Under Development
Receptor Binding Assay (RBA) Approved Limited Use PSP - Shellfish screening for clams and scallops only Growing Area Management SLV (2013; Proposal 13-114) Checklist Under Review (19-141)
ELISA Approved Limited Use NSP - oysters, hard clams, sunray venus clams; positive tests require MBA Growing Area Management SLV (2017; Proposal 17-107 )                                                           Marbionc

 

 

 

For additional information or questions, please contact CFSAN at CFSANDSSLEOS@FDA.HHS.GOV

Site Map © 2016 - 2024 ISSC. All rights reserved.